The detailed technical knowledge of EAS Senior Directors and Independent Consultants sets us apart from the competition and EAS frequently offers webinars in a public forum to provide a regulatory overview of hot topics that enable greater industry understanding. These public webinars are also available on-demand, here on the EAS website. We hope that you find them informative and welcome any questions or comments.
Tips to Streamlining the Drug Master File Process
February 12, 2020
Presented by Priya Jambhekar The meticulous detail of a Type II Drug Master Files (DMF) enables FDA to review and assess the chemistry, manufacturing, stability, purity, impurity profile, packaging and Good Manufacturing Practices data of Active Pharmaceutical Ingredients (API) or a finished drug dosage form, keeping confidential sensitive intellectual property while enabling two pharmaceutical firms […]
Codex Opportunities for Food Manufacturers
January 16, 2020
Presented by Richard White and Allen Sayler Can Codex food standards and various food safety, hygiene guidelines and codes of practice positively impact domestic food manufacturers that do not export? The short answer is “YES!” Codex provides a transparent international platform for food safety and hygiene as well as manufacturing practices, food standards (ranging from dairy […]
Dietary Supplements and FSMA Compliance – Fallacy or Fact?
December 4, 2019
Tara Lin Couch, Ph.D. & Allen Sayler In 1994 the Dietary Supplement Health and Education Act (DSHEA) created a new, legal class of products, called “Dietary Supplements”, which are regulated by the FDA as a subcategory of foods. Since DHSEA, the Food Safety Modernization Act (FSMA) of 2011 was passed, and as a category of […]
Dietary Supplement GMP Enforcement – a Look at Recent FDA Observations and Warning Letters
November 7, 2019
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 […]
How to be an Effective and Sought-After Expert Witness
November 6, 2019
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’ […]
Navigating CBP and Prior Notice of FDA’s Imported Products
October 29, 2019
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’s Transition from CFR 820 to the ISO 13485:2016 – Instituting a New Quality Management System (QMS)
September 25, 2019
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 […]
Food Defense – Untangling the Challenges and Strengthening Opportunities
September 12, 2019
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 […]
Understanding GRAS Submissions and Avoiding Data Pitfalls- Meet FDA Requirements
August 22, 2019
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 […]
Preparing for FDA Inspections, a Look at Recent Observations and Trends
July 24, 2019
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 […]
GMPs for OTCs – Improving Compliance as FDA Eyes Enforcement Actions
June 20, 2019
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, […]
Understanding the Food Fraud Puzzle
June 18, 2019
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 […]
FDA 21 CFR-Part 11 Compliance Audit
May 14, 2019
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 […]
Cosmetics Claims – Words Do Matter
May 7, 2019
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 […]
Qualified Individuals – FDA’s Final Link in the Chain of Food Safety and Food Imports
April 3, 2019
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 […]
Regulatory, Technical and Formulations for New Infant Formula Notifications – Challenges and Opportunities
April 2, 2019
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 […]
Cosmetics Labeling and Claims Regulations – Part 3
March 28, 2019
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?
March 13, 2019
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 […]
OTC Drugs, Labeling and Listing Requirements – Part 2
February 27, 2019
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
February 7, 2019
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 […]
OTC Drug Monographs, Past, Present, and Future – Part 1
January 16, 2019
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
October 18, 2018
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 […]
“Own Label Distributor” Responsibilities
October 11, 2018
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, […]
Preparing for Tobacco TPMPs in Cooperation with TMA
October 9, 2018
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 […]
Are Industry-Initiated Environmental Swab-a-Thons a Benefit?
September 17, 2018
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 […]
Temporary Marketing Permits – Opportunity and Pitfalls of the Specialized FDA Application
August 23, 2018
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 […]
Preparing for Foreign FDA Inspections
August 22, 2018
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 […]
Quality Systems for the Cannabis Industry – Preparing for State GMP Regulations
August 15, 2018
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 […]
Conferencia web de EAS: Programa de verificación de proveedores extranjeros – ¿qué significa para usted?
June 6, 2018
Foreign Supplier Verification Program – What Does it Mean for You?En EspanolSi 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 […]
The Role of Your US Agent
February 27, 2018
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 […]
Medical Device Quality Auditing
January 29, 2018
Presenter: EAS Independent Consultant – George Gary CalafactorMedical 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 […]
Unraveling The Impact of FSMA On Acidified Food Regulations
December 18, 2017
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 […]
How to Select and Qualify a Contract Laboratory
November 21, 2017
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 […]
What is a Scientifically Valid Method?
October 31, 2017
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 […]
Using Analytical Instrumentation Appropriately
October 20, 2017
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 […]
21 CFR 111 GMP Laboratory Overview
October 12, 2017
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 […]
Key Changes in SQF 8.0
September 13, 2017
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 […]
Foreign Supplier Verification Program – What Does It Mean For Your Business
June 21, 2017
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 […]
Foreign Supplier Verification Program, FSMA’s Next Big Challenge
April 18, 2017
EAS Client – Exclusive WebinarThe 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)” […]
Quality Agreements in the Complex World of Dietary Supplements
June 10, 2016
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 […]
How to Successfully Respond to FDA 483s and Warning Letters
June 6, 2016
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 […]
Managing FDA Inspections
October 2, 2015
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 […]
FDA Strategies to Implement & Enforce the Food Safety Modernization Act
August 15, 2015
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 […]
Regulatory Compliance Strategies for Marketing Dietary Supplements on Social Media
June 18, 2015
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 […]