Homeopathic manufacturers attending the American Association of Homeopathic Pharmacists’ (AAHP) Quality & Safety Summit this summer will gain valuable insight during three sessions developed by George Bernstein, PhD, a well-known compliance expert for both homeopathic and allopathic companies. The limited-seating workshops will also provide easy access to this notable consultant for specific questions during this time of change for the industry.
Dr. Bernstein, president of MAI Consulting Inc. in Chapel Hill, NC, will draw upon his more than 30 years of pharmaceutical manufacturing and compliance consulting experience to help homeopathic manufacturers prevent inspection problems before they arise and address compliance issues if they do arise. As a pharmaceutical consultant, he works to improve the efficiency, compliance, and quality of small, medium, and large domestic and global pharmaceutical companies. Dr. Bernstein, his family, and their pets have been using homeopathic medicines for more than 30 years.
The AAHP Summit will feature three tracks—Quality, Safety and Regulatory. As the leader of the Quality Track, Dr. Bernstein will work with other knowledge leaders to develop and present practical recommendations that will deliver the most value to attendees. The three Quality Track sessions are:
- Establishing Analytical Specifications
- Process Validation
- Finished Product Testing/Content Uniformity
“Now more than ever, it is time for the homeopathic industry to come together and learn best practices and new approaches for manufacturing our products,” said Mark Land, AAHP president. “The focused program should provide attendees ample interaction with knowledgeable leaders like George—all at a fraction of the cost it would require for individual companies to hire consultants.”
Dr. Bernstein has shared his expertise with AAHP members in the past through an address at the association’s semiannual meeting last March and webinars on preparing for an FDA (U.S. Food and Drug Administration) audit (“The FDA is Coming,” March 2018) and process validation (“The Validation Master Plan” in 2009). He has helped many pharmaceutical companies, including homeopathic manufacturers, to address and resolve 483 and Warning Letter observations, and with FDA communications.
The AAHP Summit, “Challenges and Solutions in Quality & Safety of Homeopathic Drug Products: Keeping Your Business Compliant under FDA’s New Proposed Guidance” is scheduled for June 28, 2019 in Baltimore in conjunction with NCH and AIH’s Joint American Homeopathic Conference. Registration will open in the coming weeks.
For more information, visit www.theaahp.org/events.