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Mr.Max Lazar
Area Of Expertise : Pharma
35 Years Of Experience
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, 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 international standard, Max is uniquely qualified to share and explain the EWG’s intent of this new guidance.
His almost 50-year career in the Pharmaceutical Industry includes numerous memberships and chairs of committees. He founded and chaired the Pharmaceutical Manufacturers Association’s (PMA) 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 during his career including SOCMA, PDA, DIA, the original IVT, and PhRMA.
Max was named by PhRMA, Topic Leader and voting member of the ICH Q7A team that negotiated and developed the ICH API GMP document. 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 represented USA industry at significant API meetings including the BPC PIC/S Conference in Canberra, Australia and the WHO/CDC/FDA Diethylene Glycol Contamination Prevention Workshop that followed the Haitian tragedy where almost 100 children died. Max was named as PhRMA’s representative on the FDA PQRI initiative for the initial Bulk Substance projects. He was Vice Chair of the USP Pharmaceutical Waters Expert Committee (2000-2005), re-elected to another 5-year term (2005-2010) as a member of this USP Expert committee, and is currently an official member of the USP water panels (2010-2015).
3 results Found
Recorded Webinar
Auditing API Facilities
This webinar discusses most, if not all of the important issues surrounding “Auditing of API Facilities”. When and how to perform and audit any API Facilities, how to prepare for an audit, performing an audit, and what to examine during the audit. Discussed are the s ...
- Advanced
- 60 Mins
Recorded Webinar
ICH Q7 API GMP Guidelines from an Insider’s Practical Perspective
This webinar will examine the history of Q7, reason for its development, and reasons why it differs from Drug Product GMP. The reasons for differences are important to understand. The program looks at the sections that make up API GMP and during this limited time ...
- Basic & Intermediate
- 90 Mins
Recorded Webinar
Auditing API (Active Pharmaceutical Ingredient) Facilities
This webinar discusses most, if not all of the important issues surrounding “Auditing of API Facilities”. When and how to perform and audit any API Facilities, how to prepare for an audit, performing an audit and what to examine during the audit. Discussed are th ...
- Basic & Intermediate & Advanced
- 60 Mins