A Webinar on Compendial Definitions and Homeopathic GMPs changes
Wednesday, May 16, 2018
1:00 pm ET • 12:00 pm CT • 11:00 am MT • 10:00 am PT
The HPCUS has clarified the definitions affecting the OTC / Rx and External Use Attenuations. Updates are also being made to attenuation levels for selected monographs. The HPCUS has updated the Compendium’s Good Manufacturing Practices Guidelines to incorporate information in recent FDA documents. These changes and updates can affect your business, your cGMP compliance, your products, and your long-term success in the market!
This webinar will review the wording and rationale for changes in the definitions that accompany the HPUS attenuation tables. The Council on Pharmacy has reviewed and revised the definitions to provide clarity and eliminate confusion. The webinar will also cover the changes in the HPUS Good Manufacturing Practices Guidelines and the Guidelines for Manufacturing Homeopathic Medicines, which have been made to bring them into harmony with a recent FDA guidance document on APIs.
Attend this one hour webinar for an overview of how these definitions and guideline changes might affect your company and your products. In addition, the webinar will touch on other changes and additions implanted throughout 2017. An important aspect is the background information on the research results of the HPCUS Toxicity and Safety Committee which reviews the HPUS OTC attenuation levels and makes recommendations for changes that are ebing implemented by the Convention.
Whether you manufacture or just market homeopathic drug products, the new information in the HPUS has a bearing on your products’ compliance status. Regulatory and FDA review of homeopathic products over the past year support the importance of reviewing your GMP protocols and complying with the new guidelines and attenuation levels of the HPUS.
Eric Foxman RPh looks back, and is sometimes surprised to see that he has been involved with homeopathy for 40 years. About 2/3rds of his life. “It’s not a rags-to-riches story (no one gets too rich doing homeopathic medicines),” says Eric. “It was partly a narrative of dumb luck and being in the right place at the right time. But more so, it’s a tale of finding the making of homeopathic drug products resonated ‘just right’ with what lived inside of me.” Eric has have held various positions, ranging from pharmacy clerk/helper while in high school to homeopathic compounding pharmacy director, and manufacturing quality control manager. He presently provides consulting services on regulatory, labeling and GMP issues to manufacturers of homeopathic and complementary medicines.
For 38 years, Eric has been involved with the HPCUS in many capacities, including on its Board, and as chair of the Council on Pharmacy. In this latter role, Eric has helped with the review and revision of compendial documents to make them more current with contemporary cGMP expectations. For more than a quarter century, Eric has been also active on the Monograph Review and Standards & Controls Committees and their on-going work.
Many in the industry in the last 4 decades know Eric Foxman as a member or company representative of the American Association of Homeopathic Pharmacists. He is in the 8th year of his third term on the Board of Directors. He has worked on Continuing Education modules for pharmacists, and position statements of the Association. Eric has been a presenter or host of numerous AAHP Compliance Thru Education webinars addressing legal, regulatory and technical aspects of the manufacture and marketing of homeopathic drug products, as well as a series of webinars on previous updates to the HPUS.
COST: Non Members: $199. AAHP members get a $90 discount code available from the AAHP office.