Speaker Profile

Max Lazar
President, FDA Regulatory Compliance Consulting

Max Lazar retired from Hoffmann-La Roche Inc. in 2001 after 35 years, where he was Vice President, FDA & DEA Compliance. In that position he was responsible for compliance oversight of all of the Roche USA businesses including Active Pharmaceutical Ingredients, Pharmaceuticals (Solid, Liquid, and Sterile), R&D, Diagnostics, Fine Chemicals and Vitamins. Following his retirement, he established a consulting business specializing in API GMP issues and the training of personnel covering the ICH Q7A Guidance as well as the Excipient GMP (IPEC) Guidance. As a voting member of the ICH Expert Work Group (EWG) that developed and negotiated this new international standard, Max is uniquely qualified to share and explain the EWG’s intent of this new guidance. His involvement in this new API GMP pre-dates the ICH activity itself.

His more than 40-year career in the Pharmaceutical Industry includes numerous memberships and chairs of committees. He founded and chaired the Pharmaceutical Manufacturers Association’s Bulk Pharmaceutical Committee of the Quality Control Section. This chair lasted thru the reorganization of PMA into PhRMA and until Max’s retirement in 2001. He has presented at numerous meetings and training programs including SOCMA, PDA, DIA, PhRMA, Barnett, and IIR both domestically and overseas.
,br> Max was named Topic Leader for the Pharmaceutical Research and Manufacturers Association’s (PhRMA) ICH Q7A team that developed the API GMP document for ICH. He represented USA industry at the PIC/S Canberra Conference which preceded the ICH API activities and worked with FDA during the 1980 – 2000 era addressing all of the API industry related regulatory issues including the 1987 NDA Re-Write Guidelines and GMP activities. He was one of five invited industry representatives at the WHO/CDC/FDA Diethylene Glycol Contamination Prevention Workshop that followed the Haitian tragedy where almost 100 children died. This workshop developed recommendations for consideration by the Pan American Health Organization and WHO. Max was named as PhRMA’s representative on the FDA PQRI initiative that developed the initial Bulk Substance projects.

He was Vice Chair of the USP Pharmaceutical Waters Expert Committee (2000-2005) and had been re-elected to another 5-year term (2005-2010) as a member on this USP Expert committee. In 2011, USP has appointed Max to three USP Expert Panels covering various Water Subjects of interest to USP. Max conducts training and consultations on API GMP (ICH Q7A) and other FDA Compliance issues. While specializing in API, Max’s experience provides him with expertise in many areas of FDA compliance including Excipients, laboratory, documentation, sterile and oral dosage forms as well as devices, diagnostics and radiopharmaceuticals.

For his contribution to Q7A, he was awarded the USA FDA Commissioner’s Special Citation “For outstanding cooperation and achievement in developing an internationally harmonized good manufacturing practice guidance for active pharmaceutical ingredients used in human drug products."

He is a member of numerous professional organizations. He is on the Editorial Board of the Journal of GXP Compliance, the Editorial Advisory Board of Pharmaceutical Outsourcing and the Advisory Board of the GMP Manual, Maas & Peither AG – GMP Publishing. Max is listed in numerous editions of Who’s Who including Who’s Who in America and is a graduate of Brooklyn College of the City University of New York. He has contributed to several books dealing with APIs, and has written and published several guidances covering Bulk Pharmaceutical Chemicals (API) as chair of the PhRMA and PMA Bulk QC Committee and Workgroups. He resides in Surprise, AZ.

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FDA GMP requirements for APIs

FDA's API GMP requirements may or may not be obvious to all parties. GMP is an expectation defined under the U.S. Food Drug and Cosmetic Act. This United States Law establishes the authority of the FDA.

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