EAS is offering our popular Food and Dietary Supplement Labeling Seminars in Philadelphia March 12-13 and March 14-15, 2019 respectively. Join independent consultants and labeling experts Gisela Leon and Jim Hoadley, Ph.D. for an in-depth look at the various requirements surrounding the development of Nutrition and Supplement Facts Panels, including FDA’s latest requirements. Join EAS for either the Food Labeling Seminar or Dietary Supplement Labeling Seminar, or both! Group discounts for two or more employees are available.
EAS Independent Consultant, Norma Skolnik and Advisor for OTC Drugs and Labeling, Susan Crane, has co-written an article on the OTC Drug Safety, Innovation, and Reform Act. Recently published in Solid Dose Digest, the article includes a proposed review and overhaul of the OTC Monograph process, eliminating inefficiencies and allows for better response times to safety concerns. Learn more in Solid Dose Digest and join Susan in Part 2 of her Five-part webinar series on OTC Monographs. Part 1 – an Overview of the OTC Monograph system, is available On-Demand now. Part 2 on OTC Labeling and Listing Requirements takes place on February 27, 2019.
The submission stage of a New Infant Formula Notification may seem like the beginning of the end of a years-long process of research and strategic development. But, without all the right documentation in place, this last step prior to product launch can be unnecessarily delayed for those companies not well-prepared for the rigors of FDA review and assessment. Learn the steps to NIFNs as well as the pitfalls and challenges companies face in leading up to the assembling of an Infant Formula dossier. EAS Consulting Group’s experts, scientists, and leaders in their fields at FDA and industry will walk you through challenges and pitfalls which delay or prevent final FDA approval of this most important nutrient for growing infants. Join Robert Martin, Ph.D., Robert Burns, Ph.D. and Timothy Morck, Ph.D. for an informative and technical overview of one of FDA’s most challenging applications on April 2, 2019, at 1:00 pm eastern. Reserve your seat today!
EAS independent consultant, Steve Cammarn, is presenting a webinar on considerations for Developing Vitamin, Mineral and Supplement Products for Commercial and Compliance Success. Join EAS February 7, 2019, at 1 pm Eastern where Dr. Cammarn will share principles and techniques for a phased-approach of the development of vitamin, mineral, and supplements products incorporating product design, process development, supply chain establishment, and qualification. Dr. Cammarn weaves together the scientific principles as well as the overarching regulatory requirements that must be met for commercial and compliance success. Join us!
Independent Consultant Thomas Dunn discusses packaging trends in an article for Natural Products Insider. Packaging is an important component of overall product design as it protects, preserves, escorts and describes the products consumed. As consumers demand more sustainable packaging, companies are working hard to meet that demand with innovative and cost-effective products.
EAS Senior Director for Dietary Supplement Consulting Services, Tara Lin Couch, Ph.D. will instruct the next EAS seminar on Good Manufacturing Practices for Dietary Supplement Laboratories April 23, 2019 in Denver, CO. This one-day intensive program will discuss FDA’s current GMP requirements for Research and Development and Quality Control of Laboratories including physical, analytical, and microbiological laboratories. Topics include analyst training and qualification; the labs’ physical facility and environment; instrument qualification, calibration and maintenance programs and more.
Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. was interviewed for an article in Natural Products Insider on Own Label Distributors and challenges of industry to establish product specifications. According to FDA data, in fiscal year 2018, about 24 percent of the FDA Form 483 inspection reports cited firms for failing to establish specifications of finished dietary supplements. This issue is clearly a challenge for the industry and one in which OLDs should be well-versed and ensure compliance.
Independent Consultant Mehrdad Tajkarimi has published part two of his three-part series in Food Safety Magazine on designing food safety training programs to meet FSMA compliance expectations. Food safety training is critical, not only in meeting FDA
EAS has announced a new date for our Riverside, CA GMP One-Day Refresher Training. This California training, now hosted on May 14, 2019, and its sister one-day Refresher trainings in Texas, Massachusetts and New York, are designed to meet the annual requirements many companies have that enable employees to stay current in GMP requirements. EAS is hosting four GMP Refresher trainings around the country in 2019. Please join us and consider outsourcing your company’s Refresher compliance trainings to EAS!
EAS published a blog on the International Society of Pharmaceutical Engineers’ iSpeak blog on how GMPs and data integrity align for safer products and swifter approvals. FDA has noted that in recent years, findings from pharma facility inspections show increasing challenges with meeting data integrity requirements, which has led to regulatory actions including warning letters, import alerts, and consent decrees.
The December American Herbal Products Association (AHPA) Report (subscription required) included an EAS authored article on steps to develop fully compliant Standard Operating Procedures. Though the development and detail of each SOP is at the discretion of individual companies, they should provide a thorough manual that enables each employee to understand their roles and responsibilities and how to perform and document them with regard to the cGMPs. As current practices evolve, so too should SOPs as they are designed to be living documents, representing best practices and required procedures.
EAS authored an article in MedTech Intelligence on FDA’s efforts at encouraging innovation while keeping a close eye on safety as part of a medical device regulatory overhaul. FDA is working to retire outdated predicates for 510(k) submissions as well as improve their post-market surveillance system through a multi-collaborative effort called National Evaluation System for Health Technology (NEST).
Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. participated in a discussion with other industry leaders on best practices for contract laboratories in a recent Natural Products Insider. Contract labs are often enlisted to certify that products are fully and validly tested, and the relationship with these labs can sometimes be complicated by a lack of provided material and product matrix information to ensure that appropriate, scientifically valid test methodologies are used. Couch and her industry colleagues share thoughts on how to convey expectations and develop agreements.
Join EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane, as she explores the history of OTC Monographs and how OTC drug companies can expect updates to the Monograph system to impact their labels in a webinar series starting January 16, 2019. Part one will discuss the history of OTC monographs and why reforms are necessary. Part two is February 27, 2019 and will discuss understanding the FDA and FTC Labeling and Claim Requirements for Cosmetic and Homeopathic products in the OTC market. The final sessions, with dates to be announced will discuss what makes a drug an OTC and the Monographs Compliance System; and GMP obligations – understanding how the GMPs are Applied and how to prepare for FDA Inspection. Reserve your seat today!
Seafood is largely accepted based on how it is labeled or listed on a menu. This is true for seafood wholesalers, distributors as well as retailers. The financial incentive for unethical practices is huge but measures can be adopted to protect product identity and integrity. Join EAS Independent Consultant and former Director of the Seafood Inspection Program at NOAA, Tim Hansen, for a discussion on various types of fraudulent activity in the seafood industry including where and why fraud can occur in the supply chain. He’ll discuss how seafood operators, buyers, and consumers can protect themselves as well as regulatory issues and possibly short, medium and long-term solutions.
Join Tim on December 18, 2018, at 1:00 pm Eastern for his discussion on Overcoming Seafood Fraud in a complimentary webinar hosted by EAS. Reserve your seat today!
Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., has written an article for Natural Products Insider on the intersection of OLD and Quality Systems. “The development and implementation of essential own label distributor quality systems and programs will go a long way to ensure GMP compliance in a contract manufacturer partnership,” she says.
In addition, for those who missed or would like to review the very informative webinar presented by Bruce Elsner, also on OLD responsibilities, it is now available on-demand on the EAS website along with many other complimentary webinars covering a wide range of regulatory topics.
Senior Director for Food Consulting Services, Allen Sayler, published an article in Dairy Foods Magazine on FDA’s PMO (Produce Milk Ordinance) new Appendix T, which mirrors FSMA in many ways in that it requires preventive controls for those hazards not already covered in the PMO. This new requirement may well be the dairy industry’s most significant new regulatory challenge for 2019. “One of the major challenges many firms face is the establishment of acceptable written food safety programs and maintenance of required records that demonstrate compliance with Appendix T. The failure of a Grade “A” dairy plant to meet any of these requirements will result in either loss of its Grade “A” designation or a request for the state to remove its Grade “A” designation.”
EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane, will explore 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 a five-part complimentary webinar series.
Part 1 (January 16, 2019) will cover OTC Drug Monographs, Past, Present and Future and will discuss what a Monograph is, how it is used and how to interpret the different sections of the monograph.
Part 2 (February 27, 2019) will cover OTC Labeling requirements and Drug listings responsibilities.
We are just days away from the webinar that EAS is co-presenting with FDA for IFT. Declaring Dietary Fiber in Nutrition Information will be presented by Independent Consultant and labeling expert, James Hoadley, Ph.D., Douglas Balentine, Ph.D., Director at FDA’s CFSAN Office of Nutrition and Food Labeling, and Sarah Gebauer, Ph.D., Nutritionist at CFAN. The webinar will take place December 6, 2018, at 9:00 am EST. Registrations are accepted by the IFT. FDA and EAS will join forces to discuss the policy on labeling dietary fiber and unravel challenges facing the food industry as it considers the path forward.
James Evans expanded on his September 2018 issue of the month article on MRAs in an article published in Tablets and Capsules magazine. He discusses MRAs in-depth, as well as Field Action Reports, Med-Watch Reports, and Drug Quality Sampling and Testing as methods of monitoring the U.S. drug product supply chain.
EAS Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., Independent Consultant Heather Fairman and President and COO, Dean Cirotta will represent EAS at the upcoming Supplyside West show November 6-10, 2018 in Las Vegas. You may find EAS at booth #5641. EAS is also well represented in the SupplySide West technical sessions as Tara will discuss Effectively Partnering with a Contract Laboratory as part of a panel on Wednesday, November 7 from 1:30–4:30 pm; and Tara and Heather together will present on Contract Manufacturing scheduled for Saturday, November 10 from 8:30 am–11:30 am. In addition, President and COO, Dean Cirotta will moderate a panel as part of the 7thannual AHPA Botanical Congress in Cooperation with ABC on how 21 CFR 111 applies to the Dietary Supplement industry.
EAS will be presenting two sessions at the upcoming Food Safety Tech’s Food Safety Consortium taking place November 13-15, 2018 in Schaumburg, IL. Independent Consultant Andrea Yablunoksy will present on Recall Readiness: Understanding Requirements, Similarities & Differences in a USDA and FDA Program and Kathy Knutson, Ph.D. will discuss Lessons Learned in Food Safety and Applied to Cannabis-infused Edibles as part of the Cannabis Quality track. Both presentations take place on November 15th.
Seafood is largely accepted based on how it is labeled or listed on a menu. This is true for seafood wholesalers, distributors as well as retailers. The financial incentive for unethical practices is huge but measures can be adopted by processors, wholesalers, and retailers to protect product identity and integrity. Join EAS Independent Consultant, and former head of NOAA Fisheries, Tim Hansen, for a discussion on various types of fraudulent activity in the seafood industry including where and why fraud can occur in the supply chain. He’ll discuss how seafood operators, buyers, and consumers can protect themselves as well as regulatory issues and possibly short, medium and long-term solutions.
Join Tim on December 5, 2018, at 1:00 pm Eastern for his discussion. Reserve your seat today!
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 starting January 16, 2019.
Part 1 of the series, OTC Drug Monographs, Past, Present, and Future will discuss what a Monograph is and how it is used. She’ll dive into reading and interpreting the different sections of the monograph and discuss what the future might hold as Congress considers changes to the system. Join Susan on January 16, 2019, at 1:00 pm Eastern for part 1.
Later sessions will include topics such as what makes a drug an OTC and the Monographs Compliance System; OTC Labeling requirements and Drug listings responsibilities; Understanding the FDA and FTC Labeling and Claim Requirements for Cosmetic products, Homeopathic products in the OTC market; as well as OTC Drugs and Your GMP Obligations – Understanding how the GMPs are Applied and Preparation for FDA Inspection.