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The American Association of Homeopathic Pharmacists (AAHP) announces its upcoming virtual seminar on Good Manufacturing Practices (GMP) for the homeopathic industry on Oct. 18 from 12:00 p.m. to 4:00 p.m. EDT. This informative event is open to AAHP members and non-members, with registration costs ranging from $199 to $499. Early bird pricing is available until September 27.
The GMP Compliance Seminar will delve into three crucial topics, providing attendees with in-depth insights into compliance requirements sourced from the United States Food and Drug Administration (FDA), Homeopathic Pharmacopoeia of the United States (HPUS), and Code of Federal Regulations (CFR).
Tamara L. Ely, Branch Chief at the FDA Office of Manufacturing Quality, Office of Compliance, will review compliance trends.
Stephen E. Langille, Ph.D., Senior Microbiology Consultant at ValSource, Inc. and former Director of FDA CDER’s Division of Microbiology Assessment, will address a common concern among homeopathic manufacturers: microbial contamination in non-sterile drug products. Dr. Langille’s presentation will provide valuable strategies for microbial contamination control, helping manufacturers avoid FDA warning letters and enhance product safety.
Industry Consultant George Bernstein, Ph.D., will shed light on often-overlooked GMP requirements in the HPUS, specifically designed to supplement pharmaceutical cGMPs for homeopathic drug products. Dr. Bernstein’s expertise in pharmaceutical manufacturing and quality risk management will guide attendees through these essential but frequently missed compliance elements.
This seminar is essential for both domestic and foreign firms involved in the manufacturing, labeling, packaging, or holding of homeopathic drug products for sale in the United States. Attendees may include quality staff, legal and regulatory staff, product leads, product R&D staff, company leaders, and those with similar responsibilities at contract manufacturing firms.
AAHP President Mark Land expressed his enthusiasm, stating, “AAHP is thrilled to provide attendees with an opportunity to hear directly from FDA’s Branch Chief in the Office of Manufacturing Quality, Office of Compliance. This unprecedented access will help everyone in our industry understand and meet guidelines set forth by the FDA.”
Through the GMP Compliance Seminar, homeopathic manufacturers can gain valuable insights, improve their compliance practices, and be better prepared for FDA inspections, ultimately leading to the production of the safest and highest-quality homeopathic products.
Those interested in registering may do so here, and all registration or event-related questions should be directed to AAHP Secretary Eric Foxman via email at info@aahp.info or by phone at 513-402-8847.
