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, PhD
Senior Director, 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 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.

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 [View]
  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 [View]
  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 [View]
  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 [View]
  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.