Learn From Our Library of On-Demand Webinars
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.
Developing and Implementing a Supplier Qualification Program for Dietary Supplements
Presented by EAS Independent Consultant, Aisha Siddiqui. The FDA regulations dictated in 21 CFR 111, Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, require the establishment of component (Dietary Ingredient)...
Cleaning Validation – Your GMPs Depend on It
Presented by Joe McGuinness, EAS Independent Consultant. For FDA to require that equipment be clean prior to use is nothing new, with the main rationale to prevent contamination or adulteration of drug products. Per FDA’s current Good Manufacturing Practices (cGMPs), the protection against cross...
Distilling FSMA – Alcohol Beverages and the FDA
A complimentary webinar presented by Charles Breen, Senior Advisor FSMA, EAS Consulting Group and John Messinger, Senior Attorney, Lehrman Beverage Law. The question of which federal government agency(s) regulate alcohol beverages should be easy to answer. But, because beverages are also...
Scientifically Sound Specifications – No “By-Inputs” Here
Learn how to develop scientifically sound Finished Product Specifications, even when no analytical test method is available to test the final product. An EAS Complimentary Webinar June 8, 2021 at 1pm eastern presented by Steve Cammran, Ph.D., Independent Consultant.
PMTA Deficiency Letter Readiness and Response Preparation
Part 2 of a special series focusing on CTP’s requirement of PMTA submissions With Willie J. McKinney, Ph.D., Scientific Advisor for Labstat and EAS Independent Consultant & Moderated by Michael Bond, President of Labstat International. You are anxiously waiting to hear from FDA...
Medical Device Manufacturing – A Look at FDA Enforcement Trends
EAS Complimentary Webinar Presented by George Calafactor, Ph.D., EAS Independent Consultant. A look at FY 2020 FDA observations for medical device manufacturers shows a clear focus on procedural integrity and quality systems. Good Manufacturing Practices for medical devices, as found in 21 CFR...
FDA’s Food Safety Enforcement – a Look at 483s and Warning Letters
A complimentary webinar presented by Bryan Armentrout, EAS Independent Consultant. A look at FY 2020 FDA observations for foods shows clear shortfalls in industry compliance with regards to sanitation hazards, and a lack of traceability, (particularly with regards to Foreign Supplier Verification...
“Own Label” and “Private Label” Distributor Responsibilities
A complimentary EAS Consulting Group webinar Presented by Bruce Elsner. If you are an “Own Label Distributor” (OLD) or “Private Label Distributor” (PLD) it is imperative that you understand FDA compliance expectations. With more and more of the OTC drug and dietary supplement industry turning to...
PMTA State of the Union
A Situational Review with Jeff Stier Moderated by Dean Cirotta, EAS Consulting Group. As filers of FDA Premarket Tobacco Applications (PMTA)s wait for substantive reviews, the industry remains in flux due to several unresolved issues, namely the potential implications of FDA policy on flavors, the...
Medical Device or a Wellness Device?
Wellness devices are big business, creating an accountability partner for the user and providing real-time data to their medical provider. But where does a wellness device cross the line to a medical device and what does that mean for the manufacturer? From design, to claims to special
EPCRA SARA SDS RCRA An Alphabet Soup and Customer Notifications Post FDA Regulations
Ingredient suppliers have an alphabet soup of compliance requirements, beyond those of FDA. From EPA to OSHA to even DOT, all product ingredients are regulated depending on the hazards
Medical Foods – When Will the FDA Enforcement “Shoe” Drop?
The industry’s interest in Medical Foods is growing with many new products as well as the repositioning and relabeling of existing products that places them into the medical foods space. FDA’s oversight and enforcement effort focused on Medical Foods has been limited partly …
Safe Foods for Canadians – What you Need to Know
The Canadian Food Inspection Agency (CFIA) is responsible for the safety of food products sold in Canada by enforcing the recently implemented Safe Foods for Canadians Regulation (SFCR). It is a compilation of 14 sets of regulations governing safety of human …
US FDA Proposed Traceability Rule – Overview
FDA’s proposed rule “Requirements for Additional Traceability Records for Certain Foods” mandates traceability recordkeeping requirements for certain foods such as cheeses, shell eggs, some types of fish and produce. When finalized, the Traceability Regulation will be …
California Proposition 65 and the Food Industry
Proposition 65 is a statute that all companies selling products into California must comply with by providing warnings if their products contain certain chemicals that result in consumer exposure above a certain daily threshold. Failure to comply with the stringent requirements …
Preparing for a PMTA Pre-Approval Inspection
Presented by Tara Lin Couch, Ph.D., EAS Senior Director for Dietary Supplement and Tobacco Services The Family Smoking Prevention and Tobacco Control Act referred to as the Tobacco Control Act (TCA), signed into law on June 22 …
Hygiene Improvement, Monitoring & Tracking
While the “new norm” for food manufacturing hygienic practices is rapidly evolving, an intense focus on proactive assurance of food and employee safety is the top industry priority. With increased focus on hygienic practices comes an increased requirement to data …
Understanding and Mitigating Risks of Emerging Pathogens
The food industry has a history of testing for Enterobacteriaceae, coliforms and/or E. coli as indicator microorganisms. Since 2009 there were 40 outbreaks in the United States of pathogenic E. coli such as Shiga toxin-producing E. coli (STEC) associated with leafy greens…
Modifications to FDA Food Labeling Requirements – Temporary Changes During COVID-19
Compliance with food ingredient, allergen and nutrition labeling rules has never been more challenging, particularly now as manufacturers may be challenged because of raw material supply changes …
Low Acid Canned Food and Acidified Foods – Current Topics for the Food Industry
EAS Consulting Group and partner organization and testing laboratory, Certified Laboratories, are co-presenting a complimentary webinar that will review the basic regulatory requirements of low acid canned foods and acidified foods …
Selecting and Submitting an ANDA Application
The FDA Generic Drug User Fees Amendment (GDUFA) has entered a relatively matured stage with applicants of Abbreviated New Drug Applications (ANDAs) experiencing a timely review and communications regarding their submissions packet, as well as increasing approval numbers. However, until …
Retail Food Safety in a Post-Pandemic World
The Retail Food Industry is finally beginning to see an opening as many areas of the country are experiencing decreasing cases of COVID-19, meaning businesses can begin to safely scale up. But what does that mean and how can the retail food industry ensure safe operations in this new normal? Do you understand …
Virtual Book Tour – Food Safety Lessons for Cannabis-Infused Edibles
Join EAS for a live virtual book tour as independent consultant, Kathy Knutson launches her new book Food Safety Lessons for Cannabis-Infused Edibles covering the manufacturing evolution as cannabis moves from isolation …
Food Safety and Employee Protection for the Food Processing Industry During the COVID-19 Pandemic Presented in Spanish
La pandemia de COVID-19 ha puesto al mundo frente una amenaza sin precedentes. Como consecuencia de la pandemia, se han cerrado muchas empresas, escuelas e instituciones educativas, y se han restringido …
Temporary Policies Regarding Preventive Controls and FSVP During the COVID-19 Public Health Emergency
FDA has implemented temporary policies regarding compliance with FSMA’s Foreign Supplier Verification Program during the COVID-19 pandemic. What do these changes mean for your business and how can you best ensure foreign suppliers are appropriately …
Qualifying Suppliers – Dietary Supplements FSVP Requirements in the Era of COVID-19
The COVID-19 pandemic is causing major disruptions of business and the global supply chain across many industries including public health products that are regulated by the FDA. This means there is an additional challenge for these …
Fast Tracking Antimicrobial Agents – FDA’s Accelerated Programs
Developers of antimicrobial agents may seek an accelerated FDA review of their products under the accelerated programs such as Fast Track Designation, Breakthrough Therapy Designation, Accelerated Approval, or Priority Review and gain additional 5 years of …
Dietary Supplement Serious Adverse Events – Traceability Compliance in the Era of COVID-19
In the wake of COVID-19 pandemic, a number of enforcement discretion measures have been put in place by FDA, one of which pertains to the reporting of Serious Adverse Events (SAE) …
OSHA Lockout-Tagout – Critical Steps to Employee Safety
Is your manufacturing floor a safe work environment? Do you abide by OSHA controls commonly known as Lockout-Tagout? Employees can be seriously or fatally injured when machinery they clean, service or maintain unexpectedly energizes, starts up, or releases …
Practical Approaches to FSMA (PCQI, Supply Chain, FSVP) in the Era of COVID-19
A global pandemic does not negate our responsibility and requirement to maintain Food Safety in food production plants and adhere to FSMA policies set forth by the FDA. In fact, in an era of reduced workforce, supply chains may be …
Cutting Edge Methods for Detecting Food Fraud
The challenge of detecting Food Fraud has never been greater nor the economic loss to food manufacturers, importers, retailers and consumers. In the recent past, we have had to rely on the integrity of the supply chain, person to person relationships and trained sensory
Tips to Streamlining the Drug Master File Process
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 …
Codex Opportunities for Food Manufacturers
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 …
Dietary Supplements and FSMA Compliance – Fallacy or Fact?
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
Dietary Supplement GMP Enforcement – a Look at Recent FDA Observations and Warning Letters
Though FDA’s 21 CFR 111 GMPs for Dietary Supplements has been in place for over a decade, the industry continues to be plagued by the complexities of compliance…
How to be an Effective and Sought-After Expert Witness
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 …
Navigating CBP and Prior Notice of FDA’s Imported Products
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 …
FDA’s Transition from CFR 820 to the ISO 13485:2016 – Instituting a New Quality Management System (QMS)
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 …
Food Defense – Untangling the Challenges and Strengthening Opportunities
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 …
Understanding GRAS Submissions and Avoiding Data Pitfalls- Meet FDA Requirements
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 …
Preparing for FDA Inspections, a Look at Recent Observations and Trends
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 …
GMPs for OTCs – Improving Compliance as FDA Eyes Enforcement Actions
With more than 80 therapeutic categories, Over-the-Counter (OTC) drug products play an ever-increasing role in health care. FDA’s Center for Drug Evaluation and Research (CDER) working in conjunction with the Office of Regulatory Affairs (ORA) ensures that OTC products are safe to use, appropriately labeled, adverse events reports are filed and that all products are manufactured under the appropriate quality control measures. Generally, the FDA’s first and best opportunity to assess the quality and compliance conformance of an OTC drug will be during an on-site inspection of the manufacturing facility. From a Good Manufacturing Practices (GMP) perspective, manufacturers …
Understanding the Food Fraud Puzzle
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 …
FDA 21 CFR-Part 11 Compliance Audit
Regardless of the type of industry, if you are regulated by the FDA you are bound by the rules around electronic data integrity. Whether preparing to release a finished batch of material, making decisions on data and information that was created and generated electronically or preparing to file a technical dossier with the FDA; your electronic recordkeeping and other electronic data forms require more than just being available for review and inspection. The FDA requires these sources of evidence to be generated, processed and maintained in a manner that provides complete traceability, prevents unauthorized alteration …
Qualified Individuals – FDA’s Final Link in the Chain of Food Safety and Food Imports
The Food Safety Modernization Act, signed into law in 2011, includes an important provision for food importers under the Foreign Supplier Verification Program (FSVP) Final Rule. Namely, Part 1 Subpart L, Section §1.503 requires that importers of human and animal food enlist a Qualified Individual (QI) who has responsibility for developing a program and …
Regulatory, Technical and Formulations for New Infant Formula Notifications – Challenges and Opportunities
The submission stage of a New Infant Formula Notification may seem like the beginning of the end of a years-long process of research and strategic development. But, without all the right documentation in place, this last step prior to product launch can be unnecessarily delayed for those companies …
What Does the 2018 Farm Bill Mean for the Cannabis Industry?
The 2018 Farm Bill answered many questions for the cannabis industry, but its message has also been …
Developing Vitamin, Mineral and Supplement Products for Commercial and Compliance Success
Product development in the dietary supplement industry has never been more competitive. With new companies and products arriving in the marketplace …
OTC Drug Monographs, Past, Present, and Future
EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane, 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.
Pharma’s Problems with Data Integrity
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 …
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 …
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 …
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 …
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 …
Quality Systems for the Cannabis Industry – Preparing for State GMP Regulations
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 …
Conferencia web de EAS: Programa de verificación de proveedores extranjeros – ¿qué significa para usted?
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 …
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 …
Medical Device Quality Auditing
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 …
Unraveling The Impact of FSMA On Acidified Food Regulations
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 …
How to Select and Qualify a Contract Laboratory
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 …