The American Association for Homeopathic Products

AAHP Annual Membership Meeting
2023-03-16 11:00 - 12:30 (America/New_York)
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.

Tickets

Agenda

Event Information
Virtual Only
Wednesday, Oct. 18, 2023 from 12:00pm-4:00pm EST
Cost: $199-499
Open to non-members; AAHP members receive a discount.
ENTERPRISE TICKET PURCHASES: You will receive a confirmation email with instructions to register your remaining attendees following your transaction.
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

Please contact AAHP Volunteer Communications Chair Alissa Gould via email at Alissa.Gould@Boiron.com or by voice message at 610-325-8321.

Tickets

Agenda
All times below are in Eastern Daylight Time.

12:00-12:10pm

Mark Land, M.S., RAC - Welcome from AAHP

12:10-1:10pm

George Bernstein, Ph.D. - A Look at GMP Requirements in the HPUS

1:10-1:25pm

Break

1:25-2:25pm

Stephen Langille, Ph.D. - Microbial Contamination

2:25-2:40pm

Break

2:40-3:40pm

Tamara Ely - Compliance Trends

3:40-3:50pm

Mark Land, M.S., RAC - Closing

About the Speakers

George Bernstein, Ph.D.

A Look at GMP Requirements in the HPUSPresented by George Bernstein, Ph.D.President, MAI Consulting, Inc.
George Bernstein, Ph.D., is President of MAI Consulting, Inc., a consulting firm located in North Carolina. Dr. Bernstein has a Ph.D. in chemical engineering and more than 30 years of experience in pharmaceutical manufacturing, laboratory operations, data integrity, effective training, and quality risk management. Since 1988, Dr. Bernstein has consulted internationally with major pharmaceutical companies. He has lectured internationally on quality systems and root cause analysis to industry trade groups, quality organizations, including the Parenteral Drug Association and at Interphex conferences.
Dr. Bernstein’s experience, insights, and innovative problem solving have been integral to his work, which ranges from training effectiveness, GMP compliance, facility design, construction, and commissioning to business process re-engineering and process optimization. He has developed global quality standards (GLP, GCP, GPP) for a major international pharmaceutical company, and has assisted many clients with audit preparation, remediation activities, and communications with the U.S. FDA.
Dr. Bernstein recently authored the following articles on LinkedIn: “FDA and Data Integrity — 3 Perspectives,” “API Manufacturing and Data Integrity — an Auditor’s Perspective,” “So, You Want to be a Consultant? Really?” and “Training Compliance vs. Training Effectiveness.” Additionally, Dr. Bernstein is a strong proponent of homeopathy.

Stephen E. Langille, Ph.D.

Microbial ContaminationPresentation by Stephen E. Langille, Ph.D.Senior Microbiology Consultant, ValSource, Inc.
As a senior microbiology consultant at ValSource, Inc., Dr. Langille specializes in microbiological and particulate matter contamination control. Prior to this position, he spent 19 years with FDA as a microbiology reviewer, branch chief, and director of the Division of Microbiology Assessment in the Center for Drug Evaluation and Research.
Dr. Langille is a member of the United States Pharmacopeia and Parenteral Drug Association working groups on particulate and microbiological manufacturing control and participating in the writing of the FDA’s draft guidance on Microbiological Quality Considerations in Non-sterile Drug Manufacturing.
With a B.S. degree in biology from the University of Massachusetts, Dr. Langille earned his Ph.D. in microbiology from the University of Maryland.

Tamara L. Ely

Compliance TrendsPresented by Tamara L. ElyBranch Chief, Branch 6, Office of Manufacturing Quality, Office of Compliance, Center for Drug Evaluation and Research
Ms. Ely received a bachelor’s degree in chemistry from West Virginia University in 1996 and a master’s degree in quality assurance and regulatory affairs from Temple University’s School of Pharmacy in 2005. She began instructing at Temple University in 2015. As an Adjunct Associate Professor, she co-instructs a course on Microbiological Concepts for Pharmaceuticals and Current Good Manufacturing Practices.
In her career, Ms. Ely has held various quality and compliance positions within the pharmaceutical industry: analytical chemist, certified quality auditor, compliance reviewer, CGMP and validation consultant.
Since 2010, Ms. Ely has worked in the Office of Manufacturing Quality in the Center for Drug Evaluation and Research (CDER) reviewing administrative and regulatory actions regarding adulteration, evaluating inspectional findings, and determining the acceptability of manufacturing facilities. In this role, she also participates in the development of science-based regulatory policy and guidance.

Register

Early bird pricing is available through September 28, 2023 at 11:59pm EDT.

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