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Homeopathic Labeling: The FDA Is Watching – Webinar Archive
January 2, 2015 - January 2, 2018
AAHP Compliance Thru Education Webinar ARCHIVE
More than at any other time, the FTC and FDA continue to increase their scrutiny of homeopathic drug labeling and advertising. In order to protect your consumers, your brands, and your business, it is critical to have a thorough understanding of regulatory requirements.
This webinar provides a comprehensive overview of the requirements of the FDA Compliance Policy Guide for Homeopathic Drug Products, the HPUS Labeling Guidelines, and the regulations governing drug labeling and claims across the marketing mix, from product labels to websites to advertising.
In This Webinar Archive You’ll Learn How To:
- protect your consumers, products, brands, while avoiding costly errors by complying with all HPUS and required FDA labeling requirements.
- ensure your label has the required Drug Facts panel and warnings, and that you have the necessary substantiation and controls necessary for all claims.
- create advertising, websites, POS, and other communications that maximize competitive advantage while adhering to the required labeling regulations.
- distinguish OTC from Rx claims.
Note: this webinar can also be utilized by your staff in fulfillment of your required mandatory training requirements. Homeopathic manufacturers and marketers have found the AAHP to be an excellent third party source for this training.
Who Should View:
- Manufacturers, private label producers, distributors, and or marketers of homeopathic products.
- QA/QC professionals, marketing/PR staff, packaging/regulatory managers, and executives who manage or oversee labeling, consumer communications, and/or risk management.
This efficient 2.5 hour webinar archive features an expert panel of noted homeopathic industry consultants discussing the current regulatory guidelines, potential pitfalls to avoid, developing corporate guidelines/GMPS, as well as an Question and Answer period to addresses individual issues:
Meet the Presenters
Al Lorman Esq — AAHP counsel and authority on the Compliance Policy Guide. Al provides an overview of the FDA & FTC Advertising Review Process, an overview of recent enforcement actions and warning letters, and provides guidance for avoiding these mistakes. He also discusses OTC vs. Rx claims, and regulation of products containing both homeopathic and other allopathic drugs or supplements.
Eric Foxman, RPh –Secretary for the AAHP, Board Member of the HPCUS, and consultant on regulatory and GMP issues with over 35 years of involvement in the homeopathic pharmacy and manufacturing. Eric discusses the labeling requirements of the HPUS, the drug facts statements, and critical points regarding label formats and dosing, as well as requirements for marketing to adults vs. children.
George Bernstein PhD — Pharmaceutical consultant improving the efficiency, compliance, and quality of small, medium, and large domestic and global pharmaceutical companies. George provides guidance on creating a claims substantiation file, on using all the correct warnings for safety and specific condition claims. He also reviews proper cGMPs of labeling, approvals/sign off, change control, revision numbers, and label inventory controls.
This 2.5 hour Webinar DVD also contains all the handouts available during the original on-line event.
Webinar DVD archives can be ordered directly from the AAHP office at 4332 SE Logus Road, Milwaukie, OR 97222. The cost of the DVD Archive is $395 (includes S&H); AAHP members get a $200 discount.