Register now – EAS complimentary webinars offer regulatory solutions to your most complex problems

Join EAS for our upcoming regulatory webinars covering topics such as FSMA’s applicability to the dietary supplement industry, streamlining the Drug Master File process and understanding how adherence to Codex standards can improve your export opportunities.

EAS will host two complimentary webinars in December and we invite you to join us for some great regulatory compliance information. First, on December 4, Senior Directors Allen Sayler and Tara Couch, Ph.D. will co-present a webinar on FSMA’s applicability to the dietary supplement industry. This will be a fantastic presentation as Allen specializes in FSMA compliance and Tara that of dietary supplement GMPs. You may remember an earlier article co-written by the two on the subject published in EASeNews. If you would like a refresher, click here.

On December 13, Priya Jambhekar, and expert on pharmaceutical submissions will present a webinar on streamlining the Drug Master File (DMF) process. Learn what documentation is required in a DMF, and how much detail, as well as companies commonly run into issues during the FDA review of their dossiers?

[add hyperlink when ready] Join Allen Sayler and EAS Independent Consultant Richard White on January 16, 2020 for a review of how Codex, or internationally harmonized standards, can enhance your company’s trade opportunities by facilitation of food and food ingredient exports. Learn just what Codex standards are and how building your food safety programs around them can ease your export practices.

Spring 2020 EAS Compliance Trainings Scheduled for April in Long Island

Are you in need of training on food labeling, dietary supplement labeling or dietary supplement GMP compliance? EAS offers in-depth training programs for you!

[add hyperlinks when ready] EAS has scheduled our spring training seminars in Long Island this year. Join us April 12-13, 2020 for Food Labeling Compliance, April 14-15 for Dietary Supplement Labeling Compliance and April 14-15 for Dietary Supplement GMP seminars. Each of our flagship trainings are taught by our internationally recognized consultants and provide an excellent opportunity to not only learn the specific requirements but to do so in a small group setting with plenty of opportunity to practice and skill improvment.

Safety Data Sheets – A Requirement for Safe Manufacturing Operations

Safety Data Sheets are required by law for all facilities that use chemical compounds that have the potential to be hazardous. Learn the what’s and why’s of ensuring your SDS hit the mark.

Food Quality and Safety Magazine published an article written by EAS Independent Consultant Robert Kapp Safety Data Sheets (SDS) covering their importance and utilization in manufacturing operations. SDS, formerly known as Material Safety Data Sheets (MSDS), are a critical component, required by law, containing all the basic information about a chemical or product which will help to ensure the user’s safety and health all stages of its manufacture, storage, use, and disposal.

Are you Making Natural Color Claims on Your Cosmetic Products?

FDA states that all color additives are synthetic, so cosmetics making a “natural colors” claims must include only colors inherent to the ingredients.

FDA has stated all color additives are synthetic, so “natural colors” in cosmetic products must be an inherent color of an ingredient, not added for coloring, says John and Catherine Bailey, EAS Independent Consultants and experts on cosmetics. Their article on natural claims was published in the Natural Products Insider.

Ready to be an Expert Witness? Concerned about Dietary Supplement GMPs?

View our latest on-demand webinars on the EAS website

If you missed our recent webinars you are now able to view them free on-demand on the EAS website. Our Expert Witness bootcamp, presented by EAS Independent Consultant and General Counsel at Herrick Feinstein, Ronald Levine, and his colleague at Herrick, Leah Kelman provided a great opportunity to learn what is involved in acting as an expert in legal proceedings and how to market your skills for doing so. EAS is considering a full-day training on becoming and strengthening skills necessary to be an expert witness. If you be interested in participating in an event like that please contact us.

The EAS webinar on Dietary Supplement GMP Observations and Trends presented by Independent Advisor for Quality and Compliance, Robert Fish, offered a detailed look at FDA observations and discussed trends in FDA’s focus as well as tips for compliance.

Your Food Additives May Need GRAS

As innovative food companies develop an array of products to satisfy a discerning consumer, the question of whether food additives intended for use in those products are safe for their intended uses.

According to FDA, “GRAS” is an acronym for the phrase Generally Recognized ASafe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive. Product development teams must take into account the specific ingredients used and whether those ingredients are GRAS for their intended uses.  Those food additives for which GRAS has not been established require a determination of safety for that ingredient through scientific procedures. 

Are your food additives  GRAS? EAS can help you make that determination.  If you need to establish GRAS, EAS can help with the design and execution of safety studies, data organization and preparation of the dossier.  Our team of toxicologists and microbiologists have assisted countless EAS clients with GRAS and we’d be glad to discuss your product and its ingredients.  Contact Cathryn Sacra to ensure your product innovation meets FDA requirements.

From the Desk of the Chairman December 2020

Dear Readers,

Edward A. Steele

As 2019 comes to a close, it is my honor to thank you for your interest in EAS Consulting Group and convey my appreciation for your dedication to improving your understanding of FDA regulatory requirements through our EASeNews, the many articles published in trade magazines and websites, our webinars and regulatory compliance seminars. It has been another banner year for EAS, and it goes without saying, we value the trust you place in us to help you ensure your GMP and FSMA regulatory compliance is sound, your products are appropriately labeled, your technical submissions such as GRAS, DMF, 510(k) and others are prepared with the diligent attention to detail that you, and FDA, expects. Thank you for the trust you place in EAS each day and we will always strive to ensure that trust is well placed.

In particular, as we have received such good feedback on the utility (and, of course, the price) of our complimentary compliance seminars, I am pleased to say we upped our game and by year’s end will have offered 23 webinars hosted by our many talented independent regulatory consultants (most now available on-demand) ranging in topics from GMP observations for dietary supplements and pharmaceuticals to FDA’s move to a new QMS for medical devices, to what exactly is GRAS and what goes into the preparation of a dossier and more. Thousands registered for our webinars this year, which is an amazing accomplishment and indication that we are on the right track ensuring that you have an understanding of FDA requirements.

As always, when more information was needed or additional questions were raised, EAS consultants answered the call, by planes, trains and automobiles, as well as the good old-fashioned telephone, providing worldwide assistance, in many cases on very short notice. We helped firms to thwart or respond to a crisis and provided routine and actionable recommendations for improvements to a variety of issues such as SOPs, SDS, equipment sanitation, labeling challenges and more. Our in-house trainings saw a banner year as clients contracted EAS to dedicate focused training opportunities for some of their most pertinent challenges. We are pleased that more and more firms are taking a proactive approach to regulatory compliance as it is always easier to correct an issue before it becomes a full-blown problem.

I wish you a safe and happy holiday season. If ever EAS can be of assistance, please know we are always just a phone call or email away.

Sincerely,

EAS Signature Ed

Ed

Food Labeling Compliance Seminar

April 16-17, 2020

Long Island, NY

EAS’ Food Labeling Compliance Seminar has been awarded 16 CEU credits by the Commission on Dietetic Registration.

As the food industry turns its focus to compliance with the latest FDA guidance for labeling regulations, the significance of those changes and how they influence claims are raising questions. Which ingredients must be declared added sugars and which can be as dietary fiber? EAS Consulting Group, with our vast expertise in assisting food firms in all manners of FDA compliance is offering a food labeling compliance seminar in Philadelphia, PA and an opportunity to learn from our internationally renowned labeling experts.

Learn food labeling regulations from internationally renowned experts, who had primary roles at FDA in shaping current labeling regulations and experience in the development of thousands of food labels.

This hands-on, two-day seminar covers the basics of how foods need to be labeled to comply with the complex set of labeling rules, covers the latest in food labeling issues that have gotten attention from FDA, and provides answers to your most challenging questions.

Registration

$1,200

Earlybird registration of $1,000 available until February 15, 2020 (use discount code earlybird)

Group Rate, two or more from the same firm – 10% per person (group10)

Federal/State Government Employees – 50% per person (gov50)

Registrants with Promotion codes – Limit one Promotion code per transaction

Location

Hilton Garden Inn Melville
1575 Round Swamp Road
Plainview, New York 11803

https://www.hilton.com/en/hotels/jfkmlgi-hilton-garden-inn-melville/

Instructors

James E. Hoadley, Ph.D., EAS Independent Consultant

During Dr. Hoadley’s 20-year FDA career, he participated in the development of NLEA-implementing nutrition labeling and health claim regulations. As a Senior Regulatory Scientist in the Office of Nutritional Products, Labeling and Dietary Supplements (ONPLDS) Dr. Hoadley’s primary responsibilities were in food label claim regulations. In this role, he conducted scientific and regulatory reviews of petitions for new health claims and nutrient content claims.

Gisela Leon, EAS Independent Consultant

Gisela Leon brings in over 21 years of experience in international labeling of food and over 8 years’ experience in US labeling. As a regulatory consultant, she has focused on a concise review process for food, dietary supplements, and cosmetics. As a long term EAS Consultant she has reviewed hundreds of labels for US compliance and helped international products to come into compliance with US regulations. Her international labeling background allows her to point out differences or similarities with other countries.

Who Should Attend?

  • Individuals involved in management, regulatory affairs, and quality control/assurance in the manufacturing of foods.
  • Those responsible for preparing or reviewing food labels.
  • Consultants, auditors, attorneys and others interested in food labeling compliance.

At the Food Labeling Compliance Seminar, You Will

  • Learn FDA food labeling requirements from labeling experts who helped to develop and implement the current regulations and have reviewed hundreds of labels for the industry.
  • Learn about hot issues that have triggered recent FDA warning letters.
  • Apply learning in practical work sessions.
  • Have your specific issues addressed and discussed in a casual, interactive learning environment.

Seminar Handouts

  • Participant’s Manual 
  • EAS Type Size Guide
  • Food Label Handbook – Developed by EAS Independent Consultant, Gisela Leon, the 115-page guide discusses how changes to nutrient values are listed and how those changes impact claims, assisting companies in developing compliant food labels based on FDA’s final rule. (A $99 value.)

Minimum Registration Policy

Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel by March 1, 2020, and refund the registration fee in full.

Cancellation Policy

Cancellations received before February 15, 2020 will result in a $95 processing fee. No refunds will be given for cancellations received after that date. Substitutions will be allowed as long as notice is given to EAS in advance.

Terms and Conditions

By submitting this form you will be joining the nearly 20,000 who receive the monthly EASeNews regulatory newsletter. Please note EAS never shares your information and you may unsubscribe at any time.

For More Information

Contact Amy Scanlin at (571) 447-5508 or ascanlin@easconsultinggroup.com

In-House Seminar

EAS will conduct this seminar for individual firms upon request. Bringing the seminar in-house at your facilities can be a cost-effective alternative to train your employees. It also allows the program to be tailored to your particular needs. Contact Cathryn Sacra for a price quote. (571) 447-5500 or csacra@easconsultinggroup.com.

Dietary Supplement Labeling Compliance Review Seminar

April 14-15, 2020

Long Island, NY

Dietary supplement manufacturers need to keep up to date on new and changing FDA labeling policies as they will undoubtedly carry over to an increased focus on labeling enforcement. This seminar provides all that is necessary to prepare labels that comply with FDA requirements. It will address the regulatory requirements for the mandatory labeling elements and will cover allowable dietary supplement claims. Attendees will participate in a workgroup exercise to facilitate their understanding of the regulations as well as understand how dietary supplement label requirements differ from those of foods and issues that have triggered FDA enforcement actions.

Registration

$1,200

Earlybird registration of $1,000 available until February 15, 2020 (use discount code earlybird)

Group Rate, two or more from the same firm – 10% per person (group10)

Federal/State Government Employees – 50% per person (gov50)

Registrants with Promotion codes – Limit one Promotion code per transaction

Location

Hilton Garden Inn Melville
1575 Round Swamp Road
Plainview, New York 11803

https://www.hilton.com/en/hotels/jfkmlgi-hilton-garden-inn-melville/

Instructors

James E. Hoadley, Ph.D., EAS Independent Consultant

During Dr. Hoadley’s 20-year FDA career, he participated in the development of NLEA-implementing nutrition labeling and health claim regulations. As a Senior Regulatory Scientist in the Office of Nutritional Products, Labeling and Dietary Supplements (ONPLDS) Dr. Hoadley’s primary responsibilities were in food label claim regulations. In this role, he conducted scientific and regulatory reviews of petitions for new health claims and nutrient content claims.

Gisela Leon, EAS Independent Consultant

Gisela Leon brings in over 21 years of experience in international labeling of food and over 8 years’ experience in US labeling. As a regulatory consultant, she has focused on a concise review process for food, dietary supplements, and cosmetics. As a long term EAS Consultant she has reviewed hundreds of labels for US compliance and helped international products to come into compliance with US regulations. Her international labeling background allows her to point out differences or similarities with other countries.

Who Should Attend?

  • Individuals involved in management, regulatory affairs, and quality control/assurance in the manufacturing of dietary supplements.
  • Those responsible for preparing or reviewing supplement labels.
  • Consultants, auditors, attorneys and others interested in supplement labeling compliance.

At the Dietary Supplement Labeling Compliance Seminar, You Will

  • Learn FDA supplement facts panel labeling requirements from labeling experts who helped to develop and implement the current regulations and have reviewed hundreds of labels for the industry.
  • Learn about hot issues that have triggered recent FDA warning letters.
  • Apply learning in practical work sessions.
  • Have your specific issues addressed and discussed in a casual, interactive learning environment.

Seminar Handouts

  • Participant’s Manual 
  • EAS Type Size Guide
  • Dietary Supplement Label Handbook – Developed by EAS Independent Consultant, Gisela Leon, the 115-page guide discusses how changes to nutrient values are listed and how those changes impact claims, assisting companies in developing compliant food labels based on FDA’s final rule. (A $99 value.)

Minimum Registration Policy

Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel by March 1, 2020, and refund the registration fee in full.

Cancellation Policy

Cancellations received before February 15, 2020 will result in a $95 processing fee. No refunds will be given for cancellations received after that date. Substitutions will be allowed as long as notice is given to EAS in advance.

Terms and Conditions

By submitting this form you will be joining the nearly 20,000 who receive the monthly EASeNews regulatory newsletter. Please note EAS never shares your information and you may unsubscribe at any time.

For More Information

Contact Amy Scanlin at (571) 447-5508 or ascanlin@easconsultinggroup.com

In-House Seminar

EAS will conduct this seminar for individual firms upon request. Bringing the seminar in-house at your facilities can be a cost-effective alternative to train your employees. It also allows the program to be tailored to your particular needs. Contact Cathryn Sacra for a price quote. (571) 447-5500 or csacra@easconsultinggroup.com.

Dietary Supplement Good Manufacturing Practices (GMP) Compliance Seminar

April 16-17, 2020

Long Island, NY

The GMPs dictated in 21 CFR 111 have been in place for over a decade, but the FDA continues to issue numerous Warning Letters to the industry for a failure to comply with even the basic tenants of the regulation.  In light of increased FDA oversight, a thorough review of industry rules for Good Manufacturing Practices (GMPS) is warranted.

EAS Consulting Group Dietary Supplement GMP Seminar helps firms prepare for increased FDA enforcement by facilitating an understanding of compliance requirements for responsibilities of domestic and foreign firms who manufacture, label, pack or hold dietary supplements for sale in the United States, including those involved with the testing, quality control and distribution of supplements.

Instructed by former a FDA compliance official, industry expert on GMPs, and a food and drug attorney, this intensive training program will help your firm stay on top of GMP requirements. 

Registration

$1,200

$1000 early-bird rate available until February 15, 2020 (use discount code earlybird)

Group Rate, two or more from the same firm – 10% per person (use discount code group10)

Federal/State Government Employees – 50% per person (use discount code gov50)

Registrants with Promotion codes – Limit one Promotion code per transaction

Location

Hilton Garden Inn Melville
1575 Round Swamp Road
Plainview, New York 11803

https://www.hilton.com/en/hotels/jfkmlgi-hilton-garden-inn-melville/

Instructors

Dr. Tara Lin Couch, EAS Senior Director, Dietary Supplement and Tobacco Services

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.

Robert Fish, EAS Independent Advisor, Quality and Compliance

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.

Marc Ullman, Of Counsel at Rivkin Radler, LLP.

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.

Who Should Attend?

  • Individuals involved in management, regulatory affairs, and quality control/assurance in the manufacturing, labeling, packaging, storing and distribution of dietary supplements.
  • Consultants, auditors, attorneys and others interested in learning about the requirements of the new dietary supplement GMPs and how they should be applied.

At the Dietary Supplement GMP Seminar, You Will

  • Learn the requirements of the final Rule and understand how they differ from the proposed rule that was published in March 2003
  • Receive detailed practical guidance on how to apply these requirements.
  • Be given an opportunity to demonstrate your understanding of GMPs in group work sessions Be coached on how to prepare for an FDA inspection and how to avoid receiving a List of Objectionable Inspection Observations (Form FDA 483) and the end of an FDA inspection.

Seminar Handouts

  • Participant’s Manual 
  • Pocket Guide: 21 CFR Part 111

Minimum Registration Policy

Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel by March 1, 2020 and refund the registration fee in full.

Cancellation Policy

Cancellations received February 15, 2020 will result in a $95 processing fee. No refunds will be given for cancellations received after that date. Substitutions will be allowed as long as notice is given to EAS in advance.

Terms and Conditions

By submitting this form you will be joining the nearly 20,000 who receive the monthly EASeNews regulatory newsletter. Please note EAS never shares your information and you may unsubscribe at any time.

For More Information

Contact Amy Scanlin at ascanlin@easconsultinggroup.com or 571-447-5508 

In-House Seminar

EAS will conduct this seminar for individual firms upon request. Bringing the seminar in-house to your facilities can be a cost-effective alternative to train your employees. It also allows the program to be tailored to your particular needs.

Contact Tara Lin Couch, Ph.D. for a price quote. 571-447-5510 or tcouch@easconsultinggroup.com

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.

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.

Jermeale Lewis-Johnson LCB CCS

Thank you for the webinar today. I truly enjoy learning about FDA regulations when it’s broken down, so that I can research more. I look forward to learning with your next topic.

How to be an Effective and Sought-After Expert Witness

On-Demand

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.

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.

Terms and Conditions

By submitting this form you will be joining the nearly 20,000 who receive the monthly EASeNews regulatory newsletter. Please note EAS never shares your information and you may unsubscribe at any time.

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

On-Demand

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.

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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