AAHP GMP Compliance Seminar
October 18 @ 12:00 pm - 4:00 pm EDT$199 – $499
AAHP GMP Compliance Virtual Seminar
The American Association of Homeopathic Pharmacists is excited to present a virtual seminar on Good Manufacturing Practices (GMP) for our industry. This event is open to both AAHP members and non-members.
3 Crucial Topics Discussed in Depth
This half-day cGMP seminar will help homeopathic manufacturers prepare for Food and Drug Administration (FDA) inspection by facilitating an understanding of compliance requirements from both the Homeopathic Pharmacopoeia of the United States (HPUS), Code of Federal Regulations (CFR), and FDA. Learn about the most pressing enforcement topics and microbiological requirements for your products.
Tamara L. Ely, Branch Chief, FDA Office of Manufacturing Quality, Office of Compliance
Overview of recent enforcement actions against homeopathic products and FDA cGMP guidance documents.
Stephen E. Langille, Ph.D., Senior Microbiology Consultant at ValSource, Inc. and former Director of FDA CDER’s Division of Microbiology Assessment
Discussion on one of the most common reasons for an FDA warning letter to manufacturers of homeopathic products: microbial contamination in non-sterile drug products.
George Bernstein, Ph.D., Industry Consultant
Review of easily-overlooked GMP requirements in the HPUS intended to specifically supplement pharmaceutical cGMPs for homeopathic drug products.
By knowing what FDA takes into consideration, homeopathic manufacturers can better prepare for inspections and minimize their impact on day-to-day business activities. Ultimately, this crucial education leads to manufacturing excellence and the production of the safest and highest-quality homeopathic products.
Wednesday, Oct. 18, 2023 from 12:00pm-4:00pm EST
Open to non-members; AAHP members receive a discount.
What You Will Learn
- Overview and examples of inspection enforcement.
- GMP requirements specifically for homeopathic products from the HPUS.
- Design of an effective QC program.
- Microbiological quality standards for non-sterile products.
- FDA hot topics.
Who Should Attend
This seminar is a must-attend for domestic and foreign firms who manufacture, label, pack, or hold homeopathic drug products for sale in the United States.
- Quality Staff
- Legal & Regulatory Staff
- Product Leads
- Product R&D Staff
- Company Leaders (President/CEO)
- And those similarly responsible at your contract manufacturer
All times below are in Eastern Daylight Time.
Mark Land, M.S., RAC - Welcome from AAHP
George Bernstein, Ph.D. - A Look at GMP Requirements in the HPUS
Stephen Langille, Ph.D. - Microbial Contamination
Tamara Ely - Compliance Trends
Mark Land, M.S., RAC - Closing
About the Speakers
Early bird pricing is available through September 28, 2023 at 11:59pm EDT.