ALEXANDRIA, Va., Aug. 1, 2018 /PRNewswire/ --EAS Consulting Group, LLC: The Good Manufacturing Practices (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 addition, as states begin to regulate legalized cannabis, the concern of how GMPs apply to this unique industry cannot be understated. While regulations vary from state to state, the quality systems under which cannabis products are grown and manufactured have similarities that can begin to pave the way for putting practices and procedures in place to meet compliance expectations.
EAS Consulting Group, in cooperation with the American Herbal Products Association (AHPA), will be conducting a two-day intensive Dietary Supplement GMP Seminar to help firms understand their responsibilities and requirements under 21 CFR 111, while also assisting the cannabis industry in understanding how these principles can be applied to their manufacturing operations. Given by former FDA compliance officials and industry experts, this training program will provide a thorough overview of compliance expectations, covering the 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.
Early Bird Registration Rates in Effect Now: $1,000 After August 5, 2018: $1,200 All AHPA members: $1,000
Tara Lin Couch, Ph.D., EAS Senior Director, Dietary Supplement and Tobacco Services
Robert Fish, EAS Independent Advisor, Quality and Compliance
Marc Ullman, Of Counsel, Rivkin Radler, LLP
Who Should Attend?
Individuals involved in management, regulatory affairs, and quality control/assurance in the manufacturing, labeling, packaging, storing and distribution of dietary supplements and cannabis products.
Consultants, auditors, attorneys and others interested in learning about the requirements of the dietary supplement GMPs and how they should be applied.
At the Dietary Supplement GMP Seminar, You Will
Receive detailed practical guidance on how to apply the GMP 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.
About EAS Consulting Group: EAS Consulting Group, LLC (EAS) specializes in Food and Drug Administration (FDA) regulatory matters. Our prime focus is to assist domestic and foreign pharmaceutical, medical device, tobacco, food, dietary supplement, and cosmetic firms comply with applicable laws and regulations. EAS is staffed with former FDA compliance and inspection officials and industry executives and is assisted by an extensive network of independent consultants with many years of FDA and industry experience.
About AHPA: Founded in 1982, the American Herbal Products Association (AHPA) is the national trade association and voice of the herbal products industry. AHPA is comprised of more than 350 member companies, consisting primarily of domestic and foreign companies doing business as growers, processors, manufacturers and marketers of herbs and herbal products as foods, dietary supplements, cosmetics, and non-prescription drugs, and also including companies that provide expert services to the herbal trade.