Dietary Supplement GMP Enforcement – a Look at Recent FDA Observations and Warning Letters

Robert Fish, EAS Independent Advisor for Quality and Compliance

Though FDA’s 21 CFR 111 Good Manufacturing Practices (GMPs) for Dietary Supplements has been in place for over a decade, the industry continues to be plagued by the complexities of compliance. The establishment of specifications for components, in-process materials, and finished products; and then testing to those specifications has continuously been the top observation issued by the FDA. Use of a Master Manufacturing Record (MMR) that is executed for each manufactured and packaged batch, and at every batch size, in a Batch Production Record (BPR) has also been a challenge, despite the detailed list of MMR and BPR requirements provided in Subparts H and I of the regulation, respectively. In addition, having a Quality Unit that reviews and approves these specifications and records, as well as all other processes, and conducts necessary material reviews to make scientifically sound disposition decisions is a vital part of the GMP quality system that is frequently missing or inadequate.

Join EAS Consulting Group’ Robert Fish for a look at how the overall industry is complying with 21 CFR 111 through a review of recent FDA observations and Warning Letters. Gain insight to FDA’s enforcement focus as well as trends in problem areas that your firm can proactively address. When FDA shows up for a surprise inspection, you’ll be ready.

About the Presenter

Robert Fish, EAS Independent Advisor, Quality and Compliance

Robert Fish

Mr. Fish joined EAS Consulting Group, LLC in November 2006 after ten years consulting for FDA regulated industries. He spent 33 years with Food and Drug Administration (FDA), the last 6 years of that service as Director, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Prior to that position, Mr. Fish was Director of Compliance at the Nashville District Office and was also a Supervisory Investigator at the Nashville District Office. Mr. Fish began his career as an investigator in the Minneapolis District Office in 1962, and subsequently served as an Investigator at the Grand Rapids Residence Post and the Detroit District Office. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and Current Good Manufacturing Practice Regulations (GMPs) as they relate to pharmaceutical, device, and biologics manufacture. Further, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert, speaking at international events on FDA inspections and GMPs.

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How to be an Effective and Sought-After Expert Witness

Presented by Ronald Levine, EAS Consulting Group Independent Consultant and General Counsel with Herrick, Feinstein, LLP

As highly regulated industries are subject to more claims and litigations, and with growing agency challenges to ingredients, processes and branding, the target company’s regulatory compliance is often a key issue in presenting a successful defense. An expert witness’ opinion, report and testimony will play an essential role in mounting the response.

For attorneys, choosing a knowledgeable and experienced expert witness is of paramount importance. Unlike attorneys who are schooled in the world of litigation, experts often come from academia, the government and industry, and are not familiar with the unique skills required to be an effective witness.

Join EAS Consulting Group’s Independent Consultant and General Counsel at Herrick Feinstein LLP, Ronald J. Levine, for a one-hour complimentary webinar replay on the role, expectations, and required skills for being an effective expert witness.

The webinar will provide an in-depth overview of:

  • The discovery process and the role of the expert
  • The engagement process of becoming an expert
  • How experts are utilized in investigations, trials, and arbitrations
  • Projecting expertise as part of written reports and oral testimony
  • The business of being an expert witness

About the Presenter

Ron Levine has 40 years of experience advising consumer products companies in complex commercial matters. In addition to providing consulting services for EAS, he serves as the General Counsel of Herrick, Feinstein LLP, a law firm with offices in New York and Newark, NJ. He has practiced with Herrick since 1984, where he was a partner from 1985-2018. He served as Chair of the firm’s Litigation Department for 15 years.

A pragmatic advisor who helps clients anticipate, minimize and resolve the financial and reputational damage arising from claims and potential claims, Ron specializes in crisis management, for food and beverage manufacturers, and advises on class action litigations and investigations, including serving as an expert witness, related to labeling, the Food Safety Modernization Act (FSMA), advertising claims, product recalls, FDA regulations and other concerns.

The EAS Expert Witness team is greatly enhanced with the addition of Ron. By strategically matching the regulatory purview of the case at hand with our former high-level FDA and industry executives, EAS offers in-depth analysis of FDA and other Federal and state laws as well as standard industry best practices. Ron, along with Steve Armstrong, EAS Independent Advisor for Food Law and Regulation and former Chief Counsel for Campbell Soup Company and Bruce Silverglade, an EAS Independent Consultant and a Principal with the law firm Olsson Frank and Weeda Terman Matz, PC, lead the EAS Expert Witness team of consultants providing detailed and critical services to firms in all FDA commodity areas.

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Navigating CBP and Prior Notice of FDA’s Imported Products

Presented by William Scopa and Angel Suarez, EAS Independent Consultants

As the pace of FDA regulated products increases, companies importing food, dietary supplements, food additives, food and dietary ingredients to the United States must keep pace with changing regulations intended to ensure the safety of U.S. consumer and integrity of the food-based products being imported. FDA has historically seen an import rate increase of 5-10% in the last decade and in 2018, 31% of those were food products requiring prior notice.

Understanding how to navigate the FDA and US Customs import process, including how to utilize their programs to expedite the review of paperwork and shipments at the US ports of entry will be covered in some detail in this webinar. Qualifying for these “expedited” programs is critical to meeting shipment timelines in order to maintain successful business relationships with U.S. wholesalers and retailers.

As the U.S government increases its focuses on and enforcement of food fraud, food defense, and food safety regulations, existing companies or new companies intending to import food-based products into the US must be aware that requirements have changed substantially over the past year, with many more regulatory obstacles that must be addressed in order to continue a successful import business.

Additionally, of great importance to dietary supplement firms, FSMA gave new authorities to import under Subpart L Foreign Supplier Verification Program for Importers Section1.511 Importing foods subject to dietary supplement CGMP regulations. Under the prior notice all food including dietary supplements are required to file and import admissibility require follow the CGMP plus the FSVP.

Join EAS Consulting Group’s Independent Consultants William Scopa and Angel Suarez for a deep dive into the regulatory challenges of importing FDA regulated products into the US and opportunities for streamlining procedures for companies able to demonstrate a record of safety and compliance.

About the Presenters

William Scopa

William Scopa

William (Bill) Scopa has over 30 years at Customs and Border Protection (CBP) at both ports of entry and Headquarters. During his 15 years at the ports, he processed import and export clearance of cargo and passengers. At Headquarters, as a Branch Chief, he led the development of policies and procedures addressing such areas as, intellectual property rights, anti-dumping and countervailing duties, and revenue collections. He spent several years leading CBP’s trade enforcement efforts in targeting evasions such as misclassification and undervaluation. His last position was CBP’s liaison to other government agencies to develop CBP import processing of imports for EPA, FDA, and DEA.

Angel Suarez

Angel Suarez

Angel Suarez is a former Supervisor Consumer Safety Officer with the Food & Drug Administration. In this role, he had the responsibility of import enforcement in areas of seafood and Low-Acid Canned Food (LACF) as well as foreign inspections, warning letters, detentions, import alerts, import bulletins, and sample collections. He is the co-author of numerous publications including portions of the National Shellfish Sanitation Program’s Shellfish Equipment Construction Guide and the National Shellfish Sanitation Program’s Guide for the Control of Molluscan Shellfish Annotated Manual. In addition, he has developed training courses including FDA Certified Better Process Control School, Inspection and Sampling of Abnormal Food Metal Containers and the FDA Shellfish Officer Standardization Course. Angel has a B.S. with a major in Biology and minor in Chemistry and Physics from the Inter American University.

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FDA’s Transition from CFR 820 to the ISO 13485:2016 – Instituting a New Quality Management System (QMS)

Presented by George Yanulis, D.Eng., EAS Independent Consultant

FDA’s shift to a Quality System Regulation structure of ISO 13485:2016 is an effort to harmonize medical device regulations as well as reduce compliance and record keeping burdens faced by current medical device manufacturers. But will those operating under 21 CFR 820 Quality Management Systems make the voluntary switch?

While ISO 13485 is an international standard, its focus on design and development planning and controls, based on risks and outputs differs in many respects to the GMPs under which medical device firms selling products in the U.S. have been operating. Making the shift to ISO standards requires a shift in thinking, planning and execution of manufacturing policies and working procedures.

Learn more about the ISO standards and how they might benefit your business. Join George Yanulis, D.Eng., and ensure your medical device manufacturing is as efficient, safe and compliant as it can be.

About the Presenter

George Yanulis, Ph.D.

Dr. George Yanulis has consulted in Medical Device Product Development and Research for 20 years and has a Doctorate and Master’s Degree in Biomedical Engineering. He has conducted cardiovascular device research at the Cleveland Clinic Foundation on cardiac pacing paradigms used in heart failure patients. In addition, Dr. Yanulis has been involved in the R&D Medical Device Consulting & Litigation Support as an Expert Witness for over 10 years and has been involved in numerous medical device liability and patent infringement cases. He provides expertise to attorneys, medical device companies, health care systems and insurance carriers related to FDA medical device controls, PMAs, post-market surveillance issues, medical device/product failures, and IP medical device issues. In addition, he has reviewed MDR(s) and other adverse events related to implant device failure. Dr. Yanulis is highly motivated in maintaining and providing the highest level of quality in the design, development and safe and effective use of all types of cardiac device implants.

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Food Defense – Untangling the Challenges and Strengthening Opportunities

Presented by Charles Breen and Kathy Knutson, Ph.D.

EAS Independent Advisor for FSMA, Charles Breen and Consultant Kathy Knutson, Ph.D. co-present a webinar on Food Defense. Food Defense is increasingly a worry for firms as our global business climate opens opportunities for intentional harm both domestically and overseas. The ability of food manufacturers to identify and mitigate the impact of intentional attacks that compromise food safety is not only required as part of the Food Safety Modernization Act (FSMA) it makes good business sense to protect consumer health and brand reputation.

About the Presenters

Charles Breen

Mr. Breen became available to EAS Consulting Group after a distinguished career at the FDA working in areas such as HACCP and LACF and BSE prohibited materials in the dairy. Mr. Breen has worked with the industry on compliance issues related to the Bioterrorism Act of 2003 and led the field and HQ professionals in developing and implementing surveillance and compliance programs, and initial FSMA training implementation. His attention to detail has garnered him an FDA Award of Merit, Outstanding Achievement and five Commissioner Special Citations.

Kathy Knutson, Ph.D.

Kathy Knutson, Ph.D. is a microbiologist and certified lead instructor for Preventive Controls for Qualified Individuals through the Food Safety Preventive Controls Alliance. She consults with companies in meeting FSMA requirements, including manufacturers in the cannabis industry as she educates on issues surrounding cannabis infused food products for sale in states with medical and recreational use legislation. Kathy has a Ph.D. in Food Science from the University of Minnesota and prior to consulting worked as a Food Safety Educator and Proficiency Program Coordinator with the Northland Laboratories.

Understanding GRAS Submissions and Avoiding Data Pitfalls- Meet FDA Requirements

Presented by Robin Guy and Robert Kapp, Ph.D.

Before a substance can be legally added to food in the U.S., with rare exceptions, it must be either an approved food additive or determined to be generally recognized as safe (GRAS) for use in food.

Developing a food ingredient so that it is ready for GRAS submission can be a time consuming and costly process. Understanding the major components of a GRAS submission, the details of the required sections, and factors FDA considers when reviewing GRAS submissions are imperative to a successful submission and the receipt of subsequent “No Questions” response from FDA.

Join EAS Consulting Group, leaders in FDA regulatory consulting services for a review of GRAS notification requirements, strategies to strengthen preparations and communications with FDA and avoiding GRAS dossier compilation and submission pitfalls. EAS has prepared numerous GRAS notifications, helping clients to gain a new foothold in the marketplace.

This webinar could be one of the most valuable hours of time invested all year.

About the Presenters

Robin Guy

Robin Guy

Robin Guy is a board certified toxicologist and quality assurance consultant with more than thirty years of experience including nineteen years in industry (pharmaceutical toxicology & food ingredient safety assessment) and over sixteen years as an independent consultant. She is an expert in nonclinical toxicology, regulatory and Good Laboratory Practices (GLPs), designing/coordinating toxicology studies and programs, preparing regulatory submissions, including GRAS Notices, upgrading labs to GLP quality, and developing and presenting professional training courses worldwide. Prior to becoming a consultant, she served for eleven years with The NutraSweet Company/Monsanto, and for eight years with G.D. Searle & Co.

Robert Kapp, Ph.D.

Robert Kapp Ph.D.

Robert Kapp, Ph.D. has over 30 years’ experience as a toxicologist involved with the management, development, and safety of new and existing products in a broad spectrum of industries including preclinical program study design, study reports, occupational and industrial toxicology and evaluating clinical and product safety data. Dr. Kapp assists EAS clients with writing critical position papers, GRAS notifications, 510(k) submissions, US EPA Premarketing Notifications, toxicology profiles, Safety Data Sheets and labels in the US and in global markets. Prior to consulting Dr. Kapp worked as Director, Toxicology Laboratory at Exxon Biomedical Sciences, Inc. He has a Ph.D. in toxicology from George Washington University.

Preparing for FDA Inspections, a Look at Recent Observations and Trends

Presenter: Sophia Lily, EAS Independent Consultant

Foreign companies exporting FDA regulated products to the United States can at any time expect an FDA announcement of facility inspection. Looking at the complete safety package from record keeping and retention, to specifications and testing to employee training, FDA ensures foreign firms operate with the same safety standards required of companies operating within the U.S.

A look at trends of inspection findings of foreign manufacturers provides insight into industry challenges concerns garnering FDA’s increased focus.

Learn more about how FDA conducts foreign facility inspections as well as recent inspection trends. Understanding how gaps may be addressed before FDA knocks on your door will lead to a safer consumer product as well as a smoother inspection process.

About the Presenter

Sophia Lily has over 25 years of experience in the regulated pharmaceutical, nutraceutical and food industry Quality Control, Quality Assurance. Based in India, she is experienced in handling inspections, validations, vendor audits and training. She routinely works with, including training, personnel in a range of GMP topics including Data Integrity. With expertise including GMP compliance, gap analysis and remediation and development of roadmaps to compliance, she has successfully implemented effective quality management systems for many companies both small and large.

GMPs for OTCs – Improving Compliance as FDA Eyes Enforcement Actions

Presented by Bryan Coleman, EAS Senior Director for Drugs and Medical Devices

With more than 80 therapeutic categories, Over-the-Counter (OTC) drug products play an ever-increasing role in health care. FDA’s Center for Drug Evaluation and Research (CDER) working in conjunction with the Office of Regulatory Affairs (ORA) ensures that OTC products are safe to use, appropriately labeled, adverse events reports are filed and that all products are manufactured under the appropriate quality control measures. Generally, the FDA’s first and best opportunity to assess the quality and compliance conformance of an OTC drug will be during an on-site inspection of the manufacturing facility. From a Good Manufacturing Practices (GMP) perspective, manufacturers must recognize that the FDA applies the same, stringent 21 CFR 210 and 211 drug GMP standards to OTC products just as prescription drugs are held to. Thus, OTC drug manufacturers (and contract manufacturers) must maintain vigilance at all times with all aspects of production quality and documentations. From the physical plant and grounds, employee training, testing and specifications, including Out of Specifications (OOS) results management, compliance expectations with 21 CFR 211 are clearly articulated.

About the Presenter

Bryan Coleman

Bryan Coleman

Join Bryan Coleman, EAS Senior Director for Drugs and Medical Devices for a complimentary webinar on June 13, 2019 at 1:00 pm eastern where he will discuss the specifics of GMP compliance under 21 CFR Part 211 and common pitfalls that warrant increased FDA attention.

Understanding the Food Fraud Puzzle

EAS, SQFI and Food Safety News Offer a Complimentary Webinar

EAS Consulting Group
SQF Institute
Food Safety News

With long supply chains that can stretch around the world, Food Fraud is a hot topic for the food industry, consumers and government regulators. Food fraud’s negative impacts cause financial harm to the food manufacturing industry and public harm while fostering consumer mistrust. Examples of food fraud can be found in many food sectors including spices, seafood, meat and dairy as well as more specific examples such as olive oil, honey, coffee and saffron, just a few.

Substituting cheap ingredients and food additives is called “economic adulteration”, a violation of US federal law. In addition, when dangerous ingredients are used, crossing the line into “intentional adulteration” the crime is a felony, with the potential for jail time.

Learn what tools are available to food manufacturers and government regulators to combat this growing problem. Novel application of next-generation sequencing (NGS) screening and identification of multispecies which aims to improve food authenticity and tackle food fraud will be discussed.

How can you confirm suspicions of food fraud in order to avoid being a victim? What can you do to protect against food fraud and how can you ensure your products have all the safety nets in place to defend against intentional adulteration?

This webinar will provide a background on food fraud and provide an overview of tools available to meet the challenge of economic loss and consumer illness, injury or death caused by those with s nefarious, and potentially deadly, criminal intent.

Join Mehrdad Tajkarimi, Ph.D., EAS Independent Consultant and Leann Chuboff, VP of Technical Affairs at the Safe Quality Foods Institute (SQFI), co-sponsored by Food Safety News, for a webinar covering the many facets of food fraud and food defense and some of the mitigation strategies that must be put in place for prevention. Learn real world perspectives, definitions and solutions on a micro and macro level.

About the Presenters

Mehrdad Tajkarimi, Ph.D.

EAS independent consultant, Mehrdad Tajkarimi, is an expert in national and international food safety regulations, warehouse and wholesale manufacturing, dairy, grain, poultry and retail industries, HACCP, food defense, ISO 22000, BRC. He assists clients with organic requirements, Food Safety Modernization Act (FSMA), as well as in natural food preservatives and packaging, foodborne pathogenic and spoilage microorganisms characteristics, SPC and shelf life studies.

Leann Chuboff

LeAnn Chuboff has over 30 years of foodservice experience specializing in supply chain food safety and quality assurance. Currently LeAnn is the Vice President of Technical Affairs for the Safe Quality Food (SQF) Institute responsible for the technical elements of the SQF program including the development, maintenance and technical support of the SQF Code and supporting materials. Prior to working at the SQF Institute, LeAnn worked for the National Restaurant Association Solutions as the Director of Science and Regulatory Relations. In this role, she was responsible for the technical accuracy of the ServSafe food safety program and developed program and services on food safety and food defense to fit with all segments of the restaurant industry. LeAnn has also worked for Long John Silver’s and Boston Market in corporate quality assurance where she developed food safety and vendor approval program. LeAnn graduated from Iowa State University with a B.S. in Food Science and is active with many organizations including GFSI, AFDO and the International Association for Food Protection. She sits on several committees in an effort to enhance policy and develop programs for the industry to help protect public health.

About EAS Consulting Group

EAS Consulting Group continues 55 plus years of leadership in providing regulatory consulting to the industries regulated by FDA and other federal and state agencies. Our network of independent advisors and consultants enables EAS to provide comprehensive consulting, training and auditing services to the dietary supplement, pharmaceutical, food, medical device, tobacco and cosmetic industries. Whether the need is assistance with general FDA or USDA regulatory compliance or more specific needs such as product development, New Dietary Ingredient submissions, FSMA regulation compliance, generic or customized compliance trainings, 483 responses, product market withdrawals or recalls, mock-FDA audits, expert witness services, GRAS & food additive issues, dietary supplement labeling compliance or the development of a detailed import strategy and policy, EAS, with its over 150 consultants, former FDA compliance officials and industry experts, is able to assist. With vast expertise in FDA’s policies and enforcement, EAS is the proven choice for assistance in FDA and other regulatory matters. easconsultinggroup.com

About Safe Quality Food Institute

The Safe Quality Food (SQF) program is recognized by retailers and foodservice providers around the world as a rigorous, credible food safety management system. It is the only certification system recognized by the Global Food Safety Initiative (GFSI) that offers certificates for primary production, food manufacturing, food packaging, distribution and retail/wholesale grocers. This enables suppliers to assure their customers that food has been produced, processed, prepared and handled according to the highest possible standards, at all levels of the supply chain. Additionally as a division of the Food Marketing Institute (FMI), the SQF program incorporates continual retailer feedback about consumer concerns. This information is passed on to SQF certified suppliers, keeping them a step ahead of their competitors. https://www.sqfi.com/

About Food Safety News

Food Safety News pulls together a team of talented journalists to provide timely reporting on food safety issues. Our original, in-depth reports are published daily, and are complemented by contributed articles and opinion pieces written by food safety leaders from every sector of the industry. Our reporters have been granted access to the White House, the Supreme Court, and multiple Congressional offices alongside the nation’s leading newspapers and media networks and provide outstanding, award-winning coverage of topics ranging from policy and politics to foodborne illness outbreaks to sustainability, science and research.http://www.foodsafetynews.com

FDA 21 CFR-Part 11 Compliance Audit

Presented by Independent Consultant Jeffrey Roberts

Regardless of the type of industry, if you are regulated by the FDA you are bound by the rules around electronic data integrity. Whether preparing to release a finished batch of material, making decisions on data and information that was created and generated electronically or preparing to file a technical dossier with the FDA; your electronic recordkeeping and other electronic data forms require more than just being available for review and inspection. The FDA requires these sources of evidence to be generated, processed and maintained in a manner that provides complete traceability, prevents unauthorized alteration and requires a verified electronic signature that ensures identity and authenticity. 

Learn the specifics of Part 11 requirements for electronic signatures with Jeffrey Roberts. This complimentary webinar will discuss how record keeping is inclusive of a larger focus on GMPs for electronic records that are created, modified, maintained, archived, retrieved, or transmitted as well the specifics of content that must be included in these records for verification and validation.

About the Presenter

Jeffrey Roberts

EAS Independent Consultant, Jeffrey Roberts, is an expert in software and systems auditing/validation including compliance with 21 CFR Part 11, 21 CFR Part 820 and ISO-13485. He writes Software Development Life Cycle (SDLC) documents including Validation Compliance Plan (VCP), Functional Requirements Specification (FRS), System Design Specification (SDS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Requirements Traceability Matrix (RTM) and Validation Summary Report (VSR).

Cosmetics Claims – Words Do Matter

Presented by Independent Consultant Norma Skolnik

In the competitive cosmetics world, discerning consumers are carefully considering product purchases to determine which offer the results they are hoping to achieve. In response, the pressure on marketing and labeling teams may entice to push the envelope with regards to product claims. However, words do matter, particularly in the eyes of FDA.

The manner in which labels are worded and claims are made can make all the difference in a cosmetic product inadvertently being marketed as an unapproved drug. Once a company has crossed that line, FDA takes notes and immediate changes to the marketing strategy to correct the errors or the product will be forcefully pulled from the market with potential liability risks for the company and product owners.

Learn how the words used on a cosmetic label can alter the intended meaning of a claim and FDA views on them. Ensure your cosmetic products are labeled and marketed in a compliant manner, offering consumers an accurate understanding of what they can expect and protecting your products from FDA concerns. Join Norma Skolnik on May 7, 2019 for a complimentary webinar and ensure your cosmetic product labeling and claims are compliant with FDA regulations.

About the Presenter

Norma Skolnik

Norma Skolnik has over 35 years of regulatory experience working with the pharmaceutical, OTC drug, cosmetic and dietary supplement industries. Prior to consulting, she served as Director of Regulatory Affairs for the Americas for Cadbury Adams until her retirement. She also held the positions of Director of Regulatory Affairs for the Adams Division of Pfizer and Associate Director of Regulatory Affairs for the Warner-Lambert company.

Qualified Individuals – FDA’s Final Link in the Chain of Food Safety and Food Imports

The Food Safety Modernization Act, signed into law in 2011, includes an important provision for food importers under the Foreign Supplier Verification Program (FSVP) Final Rule. Namely, Part 1 Subpart L, Section §1.503 requires that importers of human and animal food enlist a Qualified Individual (QI) who has responsibility for developing a program and performing each activity under the program to ensure that the products that they are importing are not adulterated or misbranded (in regards to allergens) and have been produced in accordance with the preventive control regulations for human or animal food (CFR §117 & 507 respectfully), or the Produce Safety Rule (CFR §112).

Companies importing finished food and food ingredients for further processing into the U.S. must have a QI, either an employee or someone contracted to perform QI duties. This FSVP QI looks at each supplier closely and determines whether the foods or food ingredients they produce meet FDA’s strict safety requirements by assessing the supplier’s food safety plans and determining whether adequate controls are in place that would reduce or minimize harm due to biological, chemical and physical hazards. The QI would also have to identify verification activities that would ensure that the hazards are being addressed. Based on the type of activity identified, the importer may also have to enlist a Qualified Auditor (QA) to perform this function.

Everyone with a role in the importation of foreign sourced foods should be familiar with applicable FSVP requirements including brokers ,exporting shippers, foreign suppliers, and others. This comprehensive approach can help better protect food safety.

Join EAS Independent Advisor for FSMA and former FDA Seattle District Officer, Charles Breen and EAS Independent Advisor for Import Operations and former Director of the FDA’s Division of Import Operations, Domenic Veneziano, for an informative and fast-paced webinar on understanding the requirements of an FDA Qualified Individual and Auditor.

About the Presenters

Charles Breen, Independent Advisor, FSMA Consulting Services

Mr. Breen became available to EAS Consulting Group after a distinguished career at the FDA working in areas such as HACCP and LACF and BSE prohibited materials in the dairy. Mr. Breen has worked with the industry on compliance issues related to the Bioterrorism Act of 2003 and led the field and HQ professionals in developing and implementing surveillance and compliance programs, and initial FSMA training implementation. His attention to detail has garnered him an FDA Award of Merit, Outstanding Achievement and five Commissioner Special Citations.

Domenic Veneziano, Independent Advisor, Import Operations

Mr. Veneziano is a veteran FDA specialist with over 24 years of Agency experience. He served as director of the FDA’s Division of Import Operations for more than ten years. In that role, he was responsible for oversight of FDA’s import operations program and provided leadership, guidance, and direction to approximately 1,000 field investigators in more than 320 U.S. ports of entry. He also served as co-lead in the development of the FSMA import regulations and was the senior advisor on the implementation of FSMA and the FDA Safety and Innovation Act. Mr. Veneziano began his FDA career in 1992 as a field investigator in the New England District specializing in medical device inspections. In 1998 he became a supervisory investigator in New England overseeing the medical device and import programs.

Regulatory, Technical and Formulations for New Infant Formula Notifications – Challenges and Opportunities

Presented by EAS Independent Consultants Robbie Burns, Ph.D. and Timothy Morck, Ph.D. and Independent Advisor for Food and Color Additive Safety, Robert Martin, Ph.D.

The submission stage of a New Infant Formula Notification may seem like the beginning of the end of a years-long process of research and strategic development. But, without all the right documentation in place, this last step prior to product launch can be unnecessarily delayed for those companies not well-prepared for the rigors of FDA review and assessment.

Just some of the roadblocks Infant Formulas face is that all ingredients must be GRAS specifically for Infant Formula use, Approved Food Additives, or have a history of safe use in U.S. formulas. The submissions which demonstrate this must also show that their formulations deliver on nutrient label declarations throughout shelf-life with nutrient levels within FDA-established ranges. Some examples of required studies include Protein Efficiency Ratio test for protein quality, nutritional shelf life stability studies and infant growth monitoring studies, all which must demonstrate the product is produced under processing conditions that assure safe and consistent formulas. Finally, when all the data is available it is assembled into a well-designed New Infant Formula Notification (NIFN) which is submitted to and reviewed by FDA. Learn the steps to NIFNs as well as the pitfalls and challenges companies face in leading up to the assembling of an Infant Formula dossier. EAS Consulting Group’s experts, scientists, and leaders in their fields at FDA and industry will walk you through challenges and pitfalls which delay or prevent final FDA approval of this most important nutrient for growing infants. Join Robert Martin, Ph.D., Robert Burns, Ph.D. and Timothy Morck, Ph.D. for an informative and technical overview of one of FDA’s most challenging applications.

Learn more about EAS services with New Infant Formula Notifications as Allen Sayler and Robbie Burns, Ph.D. share critical information on FDA expectations for safety and submissions of NFINs.

About the Presenters

Robert Martin, Ph.D., Independent Advisor, Food and Color Additive Safety

Dr. Robert Martin is a former deputy director of FDA’s Division of Biotechnology and GRAS Notice Review. His 38-year career at the agency included service as a research chemist and as a consumer safety officer in the Division of Food and Color Additives. He became a supervisor and team leader after that division was renamed the Division of Petition Control. Dr. Martin holds a Ph.D. in chemistry from Georgetown University.

Robert Burns, Ph.D., Independent Consultant

Robert, “Robbie” Burns retired from the Grocery Manufacturers Association as former Vice President of Health and Nutrition Policy. Previously, he was the Global Nutrition and Scientific Affairs Director at Cadbury Schweppes where he worked to establish consistent global standards and strategies for the improvement of product pipelines. Prior to Cadbury, he was at Mead Johnson Nutritionals where he worked on the scientific and regulatory aspects of new and reformulated infant formulas, Medical Foods and other nutritional products. Robbie has a Ph.D. in Nutritional Biochemistry from Queens University in Belfast, Ireland with Postdoctoral Research Fellowships at the Universities of Nottingham and Illinois, Urbana-Champaign. He is the author of nearly 50 papers and articles and has been an invited speaker at dozens of international symposiums and conferences.

Timothy Morck, Ph.D., Independent Consultant

Timothy Morck provides expertise in nutrition-related research, product development, regulatory and public policy and global scientific affairs. Dr. Morck’s career includes clinical nutrition practice, research, and medical school faculty appointments, scientific association management, entrepreneurial personalized nutrition start-ups, and executive and senior management positions at several global food, nutrition and pharmaceutical companies including The Dannon Company, Mead Johnson Nutritionals, Abbott Nutrition, Nestle Health Science and Nestle Corporate Affairs. The interplay between the legal, scientific, and regulatory framework surrounding medical foods has been a particularly sharp focus for him. He received a B.S. in animal science from Penn State University, followed by MS and Ph.D. degrees in nutrition (biochemistry & physiology minors) from Cornell University.

Cosmetics Labeling and Claims Regulations – Part 3

OTC Monograph Regulations a Five Part Webinar Series

Join EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane, as she explores the history of OTC Monographs, why reforms are necessary and being undertaken now, and how OTC drug companies can expect those changes to impact their labels in the future in a five-part series.

What Does the 2018 Farm Bill Mean for the Cannabis Industry?

Presented by: Marc Ullman, Of Counsel, Rivkin Radler LLP and Tara Lin Couch, Ph.D., Senior Director, Dietary Supplement and Tobacco Services

The 2018 Farm Bill answered many questions for the cannabis industry, but its message has also been largely misunderstood. Misinterpretations as to the legality of including cannabis as an ingredient in foods, herbal products, and dietary supplements have erroneously lead firms to begin planning and production of illegal products, and, in the case of those which legally include (by state) CBD ingredients there is often little regard or understanding of how to manage the quality, including product specifications for the production of a consistent and safe product.

Join EAS Senior Tara Lin Couch, Ph.D. and special guest, Marc Ullman with Rivkin Radler for a dynamic and informative discussion on what the Farm Bill really means for the cannabis industry. What is FDA’s position on cannabis and how are the states managing the patchwork of federal regulations that make this burgeoning industry so confusing? Finally, in those cases where companies are legally producing cannabis products, what steps should be taken to implement and improve upon sound quality systems?

About the Presenters

Tara Lin Couch, Ph.D., Senior Director, Dietary Supplements and Tobacco Services

Tara Couch PhD

Dr. Couch is a Ph.D. Analytical / Organic Chemist with exceptional analytical abilities and over 25-years of diverse laboratory and regulatory experience in academic, field, contract, and manufacturing environments. She is a sought-after expert on issues pertaining to Quality Control in both pharmaceutical and dietary supplement manufacturing facilities including the establishment of specifications and the development of well-organized, sophisticated laboratories. As a consultant Dr. Couch has assisted numerous dietary supplement companies with the development, improvement, and implementation of strong Quality Systems that are scientifically sound, efficient, practical, and compliant with all FDA regulations. She also performs mock FDA inspections, gap- analyses, and contractor facility audits. In addition, Dr. Couch provides GMP and laboratory trainings via seminar, webinar, and on-site presentations.

Marc Ullman, Of Counsel, Rivkin Radler LLP

Marc Ullman

Attorney Marc Ullman represents clients in matters relating to all aspects of the firm’s practice, including Food and Drug Administration and Drug Enforcement Administration matters, regulatory issues, Federal Trade Commission proceedings and litigation. He practiced with one of New York’s leading white collar criminal defense firms for ten years, where he represented clients in both federal and state prosecutions, as well as numerous related civil matters and other litigations.

OTC Drugs, Labeling and Listing Requirements – Part 2

OTC Monograph Regulations a Five Part Webinar Series

Join EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane, as she explores the history of OTC Monographs, why reforms are necessary and being undertaken now, and how OTC drug companies can expect those changes to impact their labels in the future in a five-part series.

Developing Vitamin, Mineral and Supplement Products for Commercial and Compliance Success

Presented by Steve Cammarn, Ph.D.

Product development in the dietary supplement industry has never been more competitive. With new companies and products arriving in the marketplace at rapid speed, the pressure is on to develop something new and exciting for the consumer in order to stay ahead of the competition.

When developing new products, one area that cannot be overlooked is that of regulatory compliance with the Dietary Supplement Health and Education Act of 1994 (DSHEA), and FDA’s Good Manufacturing Practice requirements for dietary supplements per 21 CFR 111, Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements,and appropriate labeling of the dietary supplement product in accordance to 21 CFR 101, Food Labeling.

Join EAS Independent Consultant, Steve Cammarn, Ph.D., for a discussion on principles and techniques for a phased-approach of the development of vitamin, mineral, and supplements, incorporating product design, process development, supply chain establishment, and qualification. Dr. Cammarn weaves together the scientific principles as well as the overarching regulatory requirements that must be met for commercial and compliance success.

About the Presenter

Stephen Cammarn, Ph.D., is an independent consultant with EAS Consulting Group. Previously, Dr. Cammarn served 34 years as a leader in healthcare R&D and Quality Assurance with The Procter & Gamble Company. Stephen led and managed organizations that spanned the Americas, EMEA, and Asia, responsible for global Pharmaceutical Development and Quality Assurance for healthcare products. He has expertise in formulation, design, process, technical support, quality and regulatory aspects of pharmaceuticals, OTC medicines; vitamins, minerals and supplements; oral care products and devices, and foods. Stephen also holds numerous patents and has developed, obtained FDA approval for and launched numerous new products, and has led work to remediate contractor firms after FDA observations and Warning Letters. Stephen also has extensive experience in due diligence, joint ventures, and partnerships. Stephen holds an undergraduate degree in Chemical Engineering and a Ph.D. in Industrial Pharmacy. Stephen has also served as adjunct faculty with the University of Cincinnati College of Pharmacy, as well as on numerous community boards.

OTC Drug Monographs, Past, Present, and Future – Part 1

OTC Monograph Regulations a Five Part Webinar Series

Join EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane, as she explores the history of OTC Monographs, why reforms are necessary and being undertaken now, and how OTC drug companies can expect those changes to impact their labels in the future in a five-part series.

Pharma’s Problems with Data Integrity

Presented by Independent Consultant, Brian Nadel

FDA takes data Integrity very seriously and their many Warning Letters and Import Alerts to dosage form and Active Pharmaceutical Ingredient (API) manufacturers in the past several years, indicate that validation is a consistent problem for the pharmaceutical industry. Data integrity, or lack thereof, can have major repercussions for a firm because once FDA finds some data to be unreliable, it considers all of a firms’ data to be unreliable. FDA expects that data to be reliable and accurate, and that crucial and often overlooked validation step can ultimately cost manufacturers untold amounts in R&D, materials, product recalls, submissions, and more.

Understand the Agency’s expectations of data integrity as well as how your company can assess your compliance. Learn critical strategies and processes that each firm should undertake to limit data integrity risk and demonstrate reliable data every time.

“Own Label Distributor” Responsibilities

More and more OTC drug and dietary supplement companies are contracting out manufacturing, packaging, laboratory testing, and distribution services. This requires a full understanding of how those contract services are being conducted in order to have complete confidence that their products are meeting quality specifications and regulatory requirements. In addition in the past several years, the FDA has focused more intensely on such companies that they refer to as “own label distributors” (“OLDs”). The result has been an escalating number of FDA inspections, Form 483 inspection observations, and warning letters.

With such increasing FDA enforcement activity, it is imperative that those in responsible positions in OLDs gain a full understanding of FDA’s requirements for “knowing what and how these [contracted] activities are performed so that you can make decisions — whether to approve and release the products for distribution”. This also means that you are “responsible for ensuring that the product is not adulterated for failure to comply with CGMP requirements, regardless of who actually performs the CGMP operations”.

This webinar will include the following topics:

  • FDA’s Explanation of the Responsibilities of an “Own Label Distributor
  • How To Meet Your “OLD” Responsibilities
  • Qualifying Contract Service Providers
  • Establishing a Quality Agreement With a Contract Service Provider
  • Responsibilities of an “OLD’s” Quality Unit
  • Key SOPs/Documents & Recommended Content
  • On-Going Monitoring of a Contract Manufacturer/Packager

Time for an interactive Q&A period will be provided at the end of the presentation.

About the presenter

Bruce Elsner

EAS Independent Consultant, Bruce Elsner, has over 28 years of experience working in FDA regulated fortune 250 companies manufacturing and packaging drug, medical device, and cosmetic products. His responsibilities have included laboratory management, process control and improvement, pilot plant management, plant quality assurance management and quality systems improvement across multiple manufacturing and research facilities. He has been consulting for OTC drug and dietary supplement companies for more than 22 years in the areas cGMP compliance auditing and quality systems improvement. His experience also includes training drug and dietary supplement industry personnel in cGMP requirements, assisting in improving their levels of compliance with those regulations and helping them respond to complex issues arising from FDA inspection observations, warning letters and consent decrees.

Preparing for Tobacco TPMPs in Cooperation with TMA

Since CTP Director, Mitch Zeller’s announcement at the 2018 TMA Annual Meeting that the Agency is prioritizing a Tobacco Product Manufacturing Practices Rule (TPMPs), the industry has been speculating regarding what these rules may encompass.

While there has been no direct guidance from the FDA to date on what may be included in a TPMP rule, some insight can be gained from the results of the numerous tobacco industry inspections that the Agency has performed over the past 6 years. Based on these inspections there are likely to be numerous requirements regarding TPMPs.

Hosted in Cooperation with the Tobacco Merchants Association, this informative webinar will provide an overview of expectations for the TPMP rule and how you can begin assessing your current quality systems.

The tobacco industry should now be performing manufacturing and quality process assessments to prepare for the development and implementation of quality systems, manufacturing and packaging controls, facilities management, material controls, equipment qualification and calibrations, equipment cleaning and maintenance processes, sanitation and environmental monitoring programs, and a personnel training program; all of which is governed by written procedures (SOPs) and documented via the generation of records. Based on Mr. Zeller’s presentation, the impending issuance of Tobacco TPMPs in conjunction with FDA’s inspectional activities indicates this preparation should begin sooner rather than later.

About the Presenters

Dean Cirotta

Dean Cirotta is the President and Chief Operating Officer for EAS Consulting Group where he is responsible for the day to day management of the technical aspects of the company with responsibility for client relations and personnel management. Mr. Cirotta is a highly accomplished Executive with 29 years of experience in the pharmaceutical and dietary supplement industries, including executive management roles with responsibility for regulatory affairs, compliance, quality assurance/control, operations, manufacturing, laboratory operations, and financial and corporate management. Mr. Cirotta works with Pharmaceutical, Dietary Supplement and Tobacco companies to ensure compliance with all applicable FDA laws and regulations. Immediately prior to joining EAS, Mr. Cirotta was President and COO of UPM Pharmaceuticals in Baltimore, Md. and prior to UPM, he was Vice President of Global Regulatory Affairs for the pharmaceutical division of Bausch & Lomb.

Tara Lin Couch, Ph.D.

EAS Senior Director for Dietary Supplement and Pharmaceutical Services, Dr. Tara Lin Couch, is a Ph.D. Analytical / Organic Chemist with exceptional analytical abilities and over 25 years of diverse laboratory and regulatory experience in academic, field, contract, and manufacturing environments. She is a sought-after expert on issues pertaining to Quality Control in pharmaceutical, dietary supplement and tobacco manufacturing facilities including the establishment of specifications and the development of well-organized, sophisticated laboratories. As a Senior Director for EAS Consulting Group, Dr. Couch has assisted numerous companies with the development, improvement, and implementation of strong Quality Systems that are scientifically sound, efficient, practical, and compliant with all FDA regulations. She also performs mock FDA inspections, gap-analyses, and contractor facility audits. In addition, Dr. Couch provides GMP and laboratory training via seminar, webinar, and on-site presentations.

 

Are Industry-Initiated Environmental Swab-a-Thons a Benefit?

The emphasis on proactive management of issues that could cause a food safety hazard, per FDA’s Food Safety Modernization Act, requires firms to improve controls for a variety of issues at all levels. One hot-button concern that continues to wreak havoc in the industry is that of pathogen contamination. It is generally understood that contamination in the processing environment will eventually make its way into the product. Even with the best of safety controls, it is imperative that companies have a robust environmental monitoring program that includes vigilant and regular testing. After all, finished product testing gives limited data and is a small snapshot of the entire lot manufactured. FDA can take hundreds of swabs during inspections, does your environmental monitoring meet that level of testing?

Temporary Marketing Permits – Opportunity and Pitfalls of the Specialized FDA Application

Food Standards are an important component of FDA’s oversight, ensuring honesty and fairness to the consumer through requirements that provide for the basic nature of a standardized food to be uniform in terms of its characteristics as well as the ingredients that it must or may contain, (i.e., mandatory and optional ingredients. But what happens when a newly developed food or production method warrants consideration of a product category outside of the standard? Petitioning to amend a food standard or to create a new one, is a lengthy and complicated process; however, a temporary solution may be available through a specialized category called a Temporary Marketing Permit(TMP’s). With TMP’s companies with novel standardized food innovations may apply to market test a food product that deviates from the standard of identity for that particular food, providing FDA with data needed to consider a future petition to amend the standard.

About the Presenter

April Kates was most recently a supervisory consumer safety officer at FDA. Prior to that position, she served with USDA’s Food Safety and Inspection Service Federal-State Audit Branch, also as a supervisory consumer safety officer. Previously, she served as manager of regulatory compliance at McCormick Spice Company, as a food regulatory specialist at American Ingredients Company (now Corbion), as a program analyst at FSIS, and as a food technologist at FDA.

Preparing for Foreign FDA Inspections

Have you ever wondered why your foreign suppliers: API, intermediates, food ingredients, etc. are suddenly in trouble with regulatory authorities? Did they just go astray or is your auditing program not performing as designed? Actually, there are several things at play. EAS Independent Consultant, Peter Saxon, will shed some light on reasons FDA inspections can “go south” as well as provide insight on how disappointing results can be managed. Saxon has personally attended 90 FDA inspections of foreign facilities and another 15 inspections by other regulatory agencies (TGA, WHO, EDQM). His insights will provide an opportunity for companies to consider improvements to their internal audit structure to help minimize regulatory risks.

About the Presenter

Peter Saxon has extensive experience in assisting pharmaceutical companies to prepare for FDA inspections of API and finished dosage plants for the U.S. market. He brings 45 years of experience in technical operations, materials management, and business development background in the pharmaceutical industry. His expertise includes pre-inspection audits, Drug Master File (DMF) preparation, equipment, cleaning, computer and process validations as well as QA training. A consultant since 1993, he has assisted major US pharmaceutical companies through FDA consent decrees and guided foreign API and finished dosage manufacturers through FDA inspections. Prior to consulting Saxon served in management roles with Ciba-Geigy Corporation, including stints in Cairo, Egypt, and Basel, Switzerland. Mr. Saxon holds an MBA from Rutgers University, and a BS in chemical engineering from Manhattan College, Riverdale, NY. He is fluent in German and has a working knowledge of Spanish, French, Arabic, and Chinese

Quality Systems for the Cannabis Industry – Preparing for State GMP Regulations

Presented by: Tara Lin Couch, Ph.D., Senior Director, Dietary Supplement and Tobacco Services

As states begin to regulate legalized cannabis, the concern of how Good Manufacturing Practices (GMPs) apply to this unique industry cannot be understated. While regulations vary from state to state the quality systems under which cannabis products are grown and manufactured have similarities that can begin to pave the way for putting practices and procedures in place to meet compliance expectations, including those of testing and quality control of in-process materials, finished batches and packaged/labeled products. The time is right for the Cannabis industry to begin assessing your manufacturing processes and implementing sound and effective quality systems in order to help you begin to prepare for GMP regulations. Stay ahead of the curve, standardize your product quality and be a leader in your industry.

About the instructor

Tara Lin Couch, Ph.D.,
Senior Director, Dietary Supplement and Tobacco Services

Tara Couch PhD

Dr. Tara Lin Couch is a Ph.D. Analytical / Organic Chemist with exceptional analytical abilities and over 25 years of diverse laboratory and regulatory experience in academic, field, contract, and manufacturing environments. She is a sought-after expert on issues pertaining to Quality Control in pharmaceutical, dietary supplement and tobacco manufacturing facilities including the establishment of specifications and the development of well-organized, sophisticated laboratories. As a Senior Director for EAS Consulting Group, Dr. Couch has assisted numerous companies with the development, improvement, and implementation of strong Quality Systems that are scientifically sound, efficient, practical, and compliant with all FDA regulations. She also performs mock FDA inspections, gap-analyses, and contractor facility audits. In addition, Dr. Couch provides GMP and laboratory training via seminar, webinar, and on-site presentations.

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Conferencia web de EAS: Programa de verificación de proveedores extranjeros – ¿qué significa para usted?

Foreign Supplier Verification Program – What Does it Mean for You?

En Espanol

Si usted exporta alimentos, ingredientes, empaques, suplementos o aditivos alimenticios hacia los Estados Unidos, su agente aduanal en los Estados Unidos, importador y clientes le pedirán proporcionar documentación para verificar que su empresa cumple con la Ley de Modernización de la Inocuidad de los Alimentos (FSMA por sus siglas en Ingles) del Departamento de Drogas y Alimentos (Food and Drug Administration o FDA). Esto incluye el cumplimiento de una serie de nuevas reglas, incluyendo “controles preventivos para alimentos humanos (PCHF)”, “controles preventivo de alimentos para animales (PCAF)”, regulaciones de seguridad de los productos agrícolas frescos, transporte sanitario y defensa de alimentos.

If you export food, food ingredients, food packaging, dietary supplements or food additives to the United States, your U.S. Customs Agent, FSVP Importer and customer now requires you to provide documentation verifying that your company is compliant with the Food Safety Modernization Act (FSMA) regulations from the U.S. Food and Drug Administration (FDA). This includes compliance with a range of new rules, including “Preventive Controls for Human Foods (PCHF)”, “Preventive Controls for Animal Feeds (PCAF)”, Produce Safety regulations, Sanitary Transport and Food Defense.

¿Qué significa esto para su negocio? ¿Qué tipos de documentos se le pedirá proporcionar a su negocio?

What does that mean for your business? What kinds of documents will your business be asked to provide?

Únete al Consultor independiente del Grupo Consultor EAS, el Dr. Gustavo González (experto originario de México), en un seminario sobre las complejidades acerca del programa de verificación de proveedores extranjeros (FSVP) y lo que esto significa para usted como proveedor de alimentos, aditivos y hortalizas exportadas a los Estados Unidos.

Join EAS Consulting Group Independent Consultant, Dr. Gusatvo Gonzalez for a webinar on the complexities of FSVP and what that means to you as a supplier of foods, food additives and produce exported to the United States, presented in Spanish.

El “programa de verificación de proveedores extranjeros (FSVP)” entró en vigor el 26 de mayo de 2017, y las fechas de cumplimiento para empresas pequeñas están ya en efecto. El FSVP requiere que los Importadores a los Estados Unidos verifiquen que sus proveedores extranjeros de alimentos, empaques, ingredientes, suplementos, aditivos y productos alimentarios importados a los Estados Unidos posean el mismo nivel de protección a la salud pública como los productores nacionales.

“Foreign Supplier Verification Program (FSVP)” went into effect on May 26, 2017, and compliance dates for smaller firms are now also in effect. The FSVP requires U.S. importers to verify that their foreign suppliers of food, food packaging, food ingredients, dietary supplements, food additives and/or product imported to the U.S. possess the same level of public health protection as is offered by domestic producers.

Únete a EAS para un webinar exclusivo, presentado en español, donde el Dr. González ayudará a las empresas a entender los requisitos y documentos necesarios para cumplir FSMA y que es lo que los importadores estadounidenses esperan de ustedes.

Join EAS for an exclusive webinar, presented in Spanish, where Dr. Gonzalez will help foreign firms understand the requirements and documents that they will have to meet under FSMA and what U.S. importers will be expecting from them.

The Role of Your US Agent

Foreign entities who operate in US FDA regulated industries must have an appointed US Agent before doing business and importing products into the US. US Agents act as an intermediary between the foreign company and FDA, assisting with two-way communication on requirements and questions such as establishment and facility registrations, product listings as well as submissions such as Foreign Color Manufacturers Testing and Approval through FDA, drug submissions such as IND, DMF, ANDA and their amendments and annual updates, and medical device applications such as 510(k), 513(g), PMA and IDE.

In addition to these basic requirements, regulatory US Agents have expertise in providing additional services to foreign clients such as technical reviews of submissions prior to FDA submission, preparation for FDA facility inspections (both through mock-inspections and desk-reviews of documentation), any Corrective Action Plans required by FDA and by providing answers to various questions surrounding the complex FDA regulatory requirements.

This webinar is presented by EAS Senior Director for Pharmaceutical and Medical Device Consulting Services, Bryan J. Coleman and Regulatory Specialist, Victoria Pankovich have covered important basic requirements of the US Agent role as well as opportunities to enhance your understanding of FDA oversight of foreign facilities.

Medical Device Quality Auditing

Presenter: EAS Independent Consultant – George Gary Calafactor

Medical Device manufacturers understand the tight FDA regulations and legal obligations surrounding devices. From initial safety and effectiveness study design through Pre-Market Applications (PMAs), Pre-Market Notifications (PMN), registration, Good Manufacturing Practices (GMPs) through reporting of adverse events, every detail must be attended to in a thorough and documented quality system. Quality systems are key indicators of a company’s commitment to producing a safe and effective product as well as a company’s good record keeping practices as records are tested and maintained to provide transparency to FDA inspectors in the case of an audit.

The more robust the quality system the better outcome companies can expect when FDA knocks at the door for both routine audits and those which are prompted by quality questions or concerns.

Good Quality Systems are verified in a variety of ways - through in-house audits; audits with the assistance of third-party consultants who specialize in quality systems; and officially by FDA inspectors. Many companies use a combination of “mock” and “desk” audits to enhance their systems, identify gaps and initiate improved procedures where necessary.

The time to assess compliance gaps is now as a product’s quality is the basis for good business practices, ensuring the safety of customers, verifying that the product works effectively and in a manner consistent with which it was approved by FDA. Quality system audits are even used in due diligence assessments in advance of mergers and acquisitions.

Join EAS Independent Consultant, George Gary Calafactor for this EAS on-demand webinar, including detailed coverage of Medical Device Quality Auditing.

  • Learn about the types and purposes of audits
  • How FDA and EU audits differ in scope
  • How quality systems link to other systems within the business practices such as
    • Accounting and Finance
    • Purchasing
    • Customer Service
    • Marketing and Sales
    • Informational Technology
  • FDA’s enforcement requirements of quality systems (Compliance Against External Requirements and Governmental Regulations)
  • Quality Assurance (Internal Goals, Objectives, and Requirements; Continuous Improvement)
  • Quality Control (Testing and Evaluation Against Standards)
  • How FDA enforces regulations and gaps found during audits
  • Trends found in FDA enforcement for medical devices in recent years

About the Presenter:

George Gary Calafactor is an EAS Independent Consultant on matters pertaining to medical device quality assurance and regulatory compliance issues. Mr. Calafactor offers a diverse background in quality consulting, auditing, manufacturing, and pharmaceutical, biologic, and medical device operations, with vast experience in the medical device industry, internal FDA operations, and the international business arena. He performs reconciliation and FDA readiness activities associated with FDA level II QSIT inspections and revises and creates quality system procedures using FDA laws, regulations, standards, and guidance documents. He also assists in various FDA inspection backroom activities including subject matter expert coaching.

Unraveling The Impact of FSMA On Acidified Food Regulations

  • Do you understand the impact of the Food Safety Modernization Act (FSMA) on Acidified Foods (AF)?
  • Do you understand the terms of AF regulations and the interplay with a modern, risk-based food safety plan?
  • Is your food safety system for AF robust enough for an inspection by the Food and Drug Administration (FDA)?

This webinar hosted by EAS Consulting Group will provide you with these answers. The webinar will be presented by EAS Independent Consultant Omar A. Oyarzabal, Ph.D., a microbiologist processing authority, and FDA Consumer Safety Officer Priya Rathnam with the Office of Compliance/Division of Compliance Policy at FDA’s CFSAN. Specific topics covered include:

  • Brief history of Low Acid Food and Acidified Food (AF) regulations
  • Definition of an AF and key terms used in AF regulations
  • The importance of recording Critical Factors
  • The unique impacts of FSMA on AF processors
  • An FDA primer on the enforcement of the LACF and AF requirements
  • Summary of recent FDA inspections of large and medium-sized AF manufacturers
  • Opportunity for improvements based on observations from FDA inspections

Together, the presenters will provide participants with detailed information and insight on acidified foods, their definition, filing requirements, and FDA expectations.

Instructors:

Priya Rathnam, M.P.H., Consumer Safety Officer, FDA

Priya Rathnam, M.P.H. is a Consumer Safety Officer in the Division of Compliance Policy/Office of Compliance at FDA’s Center for Food Safety and Applied Nutrition (CFSAN). She was previously a subject matter expert in the Division of Enforcement routinely reviewing regulatory actions related to microbial contamination in food. Priya has worked at CFSAN for over 16 years, and works closely with FDA’s Office of Regulatory Affairs and Office of Chief Counsel in determining regulatory strategies for follow up action. Currently, she works on compliance policy development. She is also co-lead for the FSMA Phase 2 workgroup for implementation of the Preventive Controls in Human foods regulation.

Omar A. Oyarzabal, Ph.D., Independent Consultant, EAS Consulting Group, LLC

EAS Independent Consultant, Omar Oyarzabal is an expert in microbiology and an Associate Professor of Food Safety at the University of Vermont Extension. He has taught food safety, bioinformatics, biostatistics, microbial risk assessment and management, and has delivered numerous international presentations and training courses on food safety in Asian and South American countries for more than 25 years. Oyarzabal serves a current member of the National Advisory Committee for Microbiological Criteria for Foods, a Certified HACCP Auditor (American Society for Quality), a Lead Instructor for the International HACCP Alliance, a Lead Instructor for Preventive Control for Human Food, Foreign Supplier Verification Program, the Sprout Safety Alliance and the Better Process Control School. Oyarzabal is the co-editor of two books: Microbial Food Safety: An Introduction, and DNA Methods in Food Safety: Molecular Typing of Foodborne and Waterborne Bacterial Pathogens. Oyarzabal also serves as the Editor-in-Chief of the scientific journal Microbial Risk Analysis, published by Elsevier. Oyarzabal holds a degree in Veterinary Medicine from the National University of Rio IV, Argentina, and an M.S. and Ph.D. degrees in food safety/microbiology from Auburn University in Auburn, AL.

How to Select and Qualify a Contract Laboratory

EAS Webinar Series on GMP Compliance in Dietary Supplement Laboratories

Back by popular demand – Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. will discuss Good Manufacturing Practice (GMP) compliance in the dietary supplement laboratory. This series, originally run in 2015, will discuss various aspects of regulatory compliance with 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, as it pertains to laboratory operations.

This series is a great opportunity to learn how to maintain a laboratory facility with effective laboratory controlled processes as well as evaluate your contract laboratory for the same. Participants in this webinar will get a basic understanding of the available analytical techniques and test methods; and when they are appropriate to establish that dietary ingredient and dietary supplement product specifications for identity, purity, strength, composition, and potential contaminants have been met.

Each one-hour webinar replay

  1. 21 CFR 111 GMP Laboratory Overview [View]
  2. Using Analytical Instrumentation Appropriately [View]
  3. What is a Scientifically Valid Method? [View]
  4. Developing Compliant Specification – No “By Inputs” Here
  5. How to Select and Qualify a Contract Laboratory [View Below]

Instructor

Tara Lin Couch, Ph.D.
Senior Director of Dietary Supplement and Tobacco Services

EAS Senior Director for Dietary Supplement and Tobacco Services, Dr. Tara Lin Couch is a Ph.D. Analytical / Organic Chemist with exceptional analytical abilities and over 25 years of diverse laboratory and regulatory experience in academic, field, contract, and manufacturing environments. She is a sought-after expert on issues pertaining to Quality Control in both pharmaceutical and dietary supplement manufacturing facilities including the establishment of specifications and the development of well-organized, sophisticated laboratories. As a consultant, Dr. Couch has assisted numerous dietary supplement companies with the development, improvement, and implementation of strong Quality Systems that are scientifically sound, efficient, practical, and compliant with all FDA regulations. She also performs mock FDA inspections, gap-analyses, and contractor facility audits. In addition, Dr. Couch provides GMP and laboratory training via seminar, webinar, and on-site presentations.

What is a Scientifically Valid Method?

EAS Webinar Series on GMP Compliance in Dietary Supplement Laboratories

Back by popular demand – Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. will discuss Good Manufacturing Practice (GMP) compliance in the dietary supplement laboratory. This series, originally run in 2015, will discuss various aspects of regulatory compliance with 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, as it pertains to laboratory operations.

This series is a great opportunity to learn how to maintain a laboratory facility with effective laboratory controlled processes as well as evaluate your contract laboratory for the same. Participants in this webinar will get a basic understanding of the available analytical techniques and test methods; and when they are appropriate to establish that dietary ingredient and dietary supplement product specifications for identity, purity, strength, composition, and potential contaminants have been met.

Each one-hour webinar replay

  1. 21 CFR 111 GMP Laboratory Overview [View]
  2. Using Analytical Instrumentation Appropriately [View]
  3. What is a Scientifically Valid Method? [View Below]
  4. Developing Compliant Specification – No “By Inputs” Here
  5. How to Select and Qualify a Contract Laboratory [View]

Instructor:

Tara Lin Couch, Ph.D.
Senior Director of Dietary Supplement and Tobacco Services

EAS Senior Director for Dietary Supplement and Tobacco Services, Dr. Tara Lin Couch is a Ph.D. Analytical / Organic Chemist with exceptional analytical abilities and over 25 years of diverse laboratory and regulatory experience in academic, field, contract, and manufacturing environments. She is a sought-after expert on issues pertaining to Quality Control in both pharmaceutical and dietary supplement manufacturing facilities including the establishment of specifications and the development of well-organized, sophisticated laboratories. As a consultant, Dr. Couch has assisted numerous dietary supplement companies with the development, improvement, and implementation of strong Quality Systems that are scientifically sound, efficient, practical, and compliant with all FDA regulations. She also performs mock FDA inspections, gap-analyses, and contractor facility audits. In addition, Dr. Couch provides GMP and laboratory training via seminar, webinar, and on-site presentations.

Using Analytical Instrumentation Appropriately

EAS Webinar Series on GMP Compliance in Dietary Supplement Laboratories

Back by popular demand – Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. will discuss Good Manufacturing Practice (GMP) compliance in the dietary supplement laboratory. This series, originally run in 2015, will discuss various aspects of regulatory compliance with 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, as it pertains to laboratory operations.

This series is a great opportunity to learn how to maintain a laboratory facility with effective laboratory controlled processes as well as evaluate your contract laboratory for the same. Participants in this webinar will get a basic understanding of the available analytical techniques and test methods; and when they are appropriate to establish that dietary ingredient and dietary supplement product specifications for identity, purity, strength, composition, and potential contaminants have been met.

Each one-hour webinar replay

  1. 21 CFR 111 GMP Laboratory Overview [View]
  2. Using Analytical Instrumentation Appropriately [View Below]
  3. What is a Scientifically Valid Method? [View]
  4. Developing Compliant Specification – No “By Inputs” Here
  5. How to Select and Qualify a Contract Laboratory [View]

Instructor:

Tara Lin Couch, Ph.D.
Senior Director of Dietary Supplement and Tobacco Services

EAS Senior Director for Dietary Supplement and Tobacco Services, Dr. Tara Lin Couch is a Ph.D. Analytical / Organic Chemist with exceptional analytical abilities and over 25 years of diverse laboratory and regulatory experience in academic, field, contract, and manufacturing environments. She is a sought-after expert on issues pertaining to Quality Control in both pharmaceutical and dietary supplement manufacturing facilities including the establishment of specifications and the development of well-organized, sophisticated laboratories. As a consultant, Dr. Couch has assisted numerous dietary supplement companies with the development, improvement, and implementation of strong Quality Systems that are scientifically sound, efficient, practical, and compliant with all FDA regulations. She also performs mock FDA inspections, gap-analyses, and contractor facility audits. In addition, Dr. Couch provides GMP and laboratory training via seminar, webinar, and on-site presentations.

21 CFR 111 GMP Laboratory Overview

EAS Webinar Series on GMP Compliance in Dietary Supplement Laboratories

Back by popular demand – Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. will discuss Good Manufacturing Practice (GMP) compliance in the dietary supplement laboratory. This series, originally run in 2015, will discuss various aspects of regulatory compliance with 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, as it pertains to laboratory operations.

This series is a great opportunity to learn how to maintain a laboratory facility with effective laboratory controlled processes as well as evaluate your contract laboratory for the same. Participants in this webinar will get a basic understanding of the available analytical techniques and test methods; and when they are appropriate to establish that dietary ingredient and dietary supplement product specifications for identity, purity, strength, composition, and potential contaminants have been met.

Each one-hour webinar replay

  1. 21 CFR 111 GMP Laboratory Overview [View Below]
  2. Using Analytical Instrumentation Appropriately [View]
  3. What is a Scientifically Valid Method? [View]
  4. Developing Compliant Specification – No “By Inputs” Here
  5. How to Select and Qualify a Contract Laboratory [View]

Instructor:

Tara Lin Couch, Ph.D.
Senior Director of Dietary Supplement and Tobacco Services

EAS Senior Director for Dietary Supplement and Tobacco Services, Dr. Tara Lin Couch is a Ph.D. Analytical / Organic Chemist with exceptional analytical abilities and over 25 years of diverse laboratory and regulatory experience in academic, field, contract, and manufacturing environments. She is a sought-after expert on issues pertaining to Quality Control in both pharmaceutical and dietary supplement manufacturing facilities including the establishment of specifications and the development of well-organized, sophisticated laboratories. As a consultant, Dr. Couch has assisted numerous dietary supplement companies with the development, improvement, and implementation of strong Quality Systems that are scientifically sound, efficient, practical, and compliant with all FDA regulations. She also performs mock FDA inspections, gap-analyses, and contractor facility audits. In addition, Dr. Couch provides GMP and laboratory training via seminar, webinar, and on-site presentations.

Key Changes in SQF 8.0

While 2017 is a year for manufacturing facilities to augment their FSMA programs for US markets, 2018 will be a year to update their GFSI systems. Beginning in January SQF advances to Edition 8.0.  Learn more about these revisions and the impact on SQF 8.0 on facilities who are, or plan to be, certified by SQF.

Instructor

Susan Moyers, Independent Consultant

Susan Moyers, Ph.D., MPH, has more than two decades of experience in developing, training and auditing food safety, quality, and dietary supplement management systems. Dr. Moyers is an SQF Certified Consultant and Trainer, a Lead Trainer for FDA’s Preventive Controls and Foreign Supplier Programs, and a consultant, auditor, and trainer for Dietary Supplement cGMPs and HACCP systems.

Kristie Grzywinski, Senior Technical Manager, FMI, SQFI

Kristie Grzywinski, Senior Technical Manager for the Food Marketing Institute’s Safe Quality Food (SQF) Institute, is responsible for delivering education solutions for SQF professionals, including SQF practitioners, consultants, and auditors in support of SQF Institute’s globally-recognized food safety and quality management standard. Grzywinski has made a career of enabling training and education in the foodservice and food manufacturing industries, including 11 years working with the National Restaurant Association’s ServSafe® training program.

Foreign Supplier Verification Program – What Does It Mean For Your Business

If you export food, food ingredients, food packaging, dietary supplements or food additives to the United States, your U.S. Importer will soon require that you provide documentation verifying that your company is compliant with the Food Safety Modernization Act (FSMA) regulations from the U.S. Food and Drug Administration (FDA). This could include compliance with a range of new rules, including "Preventive Controls for Human Foods (PCHF)", "Preventive Controls for Animal Feeds (PCAF)", and Produce Safety regulations.

What does that mean for your business? What kinds of documents will your business be asked to provide?

Join EAS Consulting Group Independent Advisor for FSMA, Charles Breen and EAS Independent Consultant Dr. Susan Moyers in a webinar directed at foreign embassy staff, and foreign food, food ingredient and food additive firms who export to the United States.

Beginning May 26, 2017, FDA’s “Foreign Supplier Verification Program (FSVP)” goes into effect for large firms; smaller firms may have additional time to comply. The FSVP requires U.S. importers to verify that their foreign suppliers of food, food packaging, food ingredients, dietary supplements and/or food additives imported to the U.S. possess the same level of public health protection as is offered by domestic producers.

In a related FSMA regulation, the FDA is also offering an optional “fast-track” in 2018 for manufacturers who have a documented safety policy and a solid record of safety in their products.

In an exclusive webinar for EAS, Charles Breen and Dr. Susan Moyers will help foreign firms understand the requirements and documents that they will have to meet under FSMA and what U.S. importers will be expecting from them.

Foreign Supplier Verification Program, FSMA’s Next Big Challenge

EAS Client - Exclusive Webinar

The US Food and Drug Administration’s will require all importers, starting at the end of May 2017 to have on hand for FDA review, significant new food safety documentation at their US office(s) for all foreign suppliers of food, food ingredients, and food additives. The FDA’s “Foreign Supplier Verification Program (FSVP)” requires importers to verify that their foreign suppliers of food, food ingredients and food additives imported into the US market are compliant with all parts of the FDA Food Safety Modernization Act (FSMA) and its “Preventive Controls for Human Foods (PCHF) and “Preventive Controls for Animal Feeds (PCAF”) regulations. The first step is to make sure all foreign suppliers are registered with FDA.

Since the FDA FSMA implementation will place significant regulatory food safety responsibility on a segment of the US food supply chain that had only limited past involvement in food safety regulatory compliance (importers), it is expected there will be both industry implementation and FDA enforcement problems. Any regulatory missteps by importers could trigger FDA import alerts to block importation of foods, food ingredients or food additives from foreign suppliers because of importer non-compliance. US food processors who rely on foreign sourced foods, food ingredients, and food additives could find themselves running short due to FDA blocking imports due to importer/broker regulatory issues related to the FDA FSMA requirements.

In an exclusive webinar for EAS, Independent Consultant Dr. Susan Moyers will discuss the FSVP rules and how to apply them, determining regulatory exposure by both importers and US-based food processors using foreign sources foods, food ingredients, and food additives, identifying exemptions, modified requirements, and documentation requirements.

This 90-minute webinar will offer practical and informative steps to ensure meeting compliance requirements, protecting against adulteration and misbranding as well as corrective actions should something go wrong.

Presenter: Dr. Susan Moyers, EAS Independent Consultant

About the presenter: Dr. Susan Moyers, has over 20 years of experience in developing, training and auditing food and dietary supplement management systems. She consults with facilities to develop and implement the BRC and SQF programs, as well as FDA’s Dietary Supplement cGMP, Preventive Controls, and Foreign Supplier standards. She also investigates and assists in resolving microbiological spoilage and food safety issues. Dr. Moyers is an SQF Registered Consultant and Trainer; a Lead Trainer for FDA’s Preventive Controls and Foreign Supplier Programs, and a consultant, auditor, and trainer for Dietary Supplement cGMPs and HACCP systems.

Dr. Moyers is a native of Philadelphia and received her undergraduate degree at Penn State. She holds a Ph.D. in Food Science and Nutrition from the University of Florida, and a Masters of Public Health degree from the University of South Florida. She currently resides in Tampa, Florida.

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Quality Agreements in the Complex World of Dietary Supplements

One of the most fundamental concepts in the dietary supplement regulation dictated in 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, is the role of the Quality Unit (QU). The QU is responsible for reviewing and approving all controlled processes and documentation; as well as making all disposition decisions for raw materials, packaging components, labels, in-process materials, and finished dietary supplement products. It is therefore essential that these quality responsibilities are clearly defined and assigned to appropriate personnel. This can be readily accomplished with a designated QU department at a single firm. However, the dietary supplement industry is an industry of contractors. Own Label Distributors (OLDs) often use multiple contractors to manufacture product, package and label product, test product, and then hold and distribute product to consumers. Given this complexity, the assignment of QU responsibilities can become quite confusing and even entirely lost. The establishment of a Quality Agreement among the contractors can resolve this by defining the QU obligations and responsibilities of each party involved. Learn what constitutes a Quality Agreement and how to establish one with your contractor in the EAS Webinar, Quality Agreements in the Complex World of Dietary Supplements.

How to Successfully Respond to FDA 483s and Warning Letters

EAS Senior Advisor for Quality and Compliance, Mr. Robert Fish, will present a webinar on How to Respond to FDA 483s and Warning Letters. He will discuss the correct and incorrect way to prepare these responses with emphasis on the FDA’s expectations. He will also explain why companies may receive an FDA 483 and how to respond in a way to prevent the issuance of a Warning Letter.”

Managing FDA Inspections

With FDA inspections becoming more frequent, particularly in the dietary supplement world, it is imperative that companies familiarize themselves with how to host and manage such an inspection. We say “manage an FDA inspection” because the more knowledge a company has the better able it will be to make the inspection process move smoothly in the direction that you help set. To provide you with that knowledge, this webinar will cover:

  • FDA compliance guidance to its inspectors
  • The scope of FDA inspectional authority
  • Receiving investigators and organizing the opening meeting
  • Employee “Do’s” and “Don’ts” during an inspection
  • Managing the inspection process
  • Wrapping up the inspection and post-inspection follow-up actions

FDA Strategies to Implement & Enforce the Food Safety Modernization Act

This FSMA webinar will explore FDA’s anticipated enforcement strategy following finalization of the Hazard Analysis and Risk-based Preventive Control (HARPC) regulations for manufactured foods. The final rule will require that each food facility identify a “Qualified Individual” to conduct a multi-factor hazard analysis, then design and implement a written plan to control significant hazards.

The HARPC rules for human and animal feed are scheduled to be published in August 2015 and will become effective 60 days thereafter, with enforcement to follow 12 to 36 months later, depending on company size.

Regulatory Compliance Strategies for Marketing Dietary Supplements on Social Media

The widespread use of social media has had an impact on how we interact in our personal and professional relationships. It is also having a profound effect on businesses and their relationships with customers. For those of us in FDA-regulated industries, there are implications for marketing strategies and what companies are allowed to say. While the FDA has provided guidance on such strategies for prescription drugs and medical devices, the rules and regulations for advertising of dietary supplement on social media have not been as clear.

Learn how these FDA guidance documents, along with those from the Federal Trade Commission, can help you to consider social media as you meet regulatory agency expectations in marketing your dietary supplement products.

Ms. Crane is an experienced professional in the pharmaceutical industry specializing in quality and regulatory compliance for over-the-counter (OTC) and dietary supplement products. She has a thorough knowledge of federal regulations on marketing, labeling, and distribution of OTC drugs and dietary supplements.