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Max Lazar

Max Lazar is Keynote Speaker at Compliance key Inc. He 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 reporting to the President. 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 Q7A 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 involvement in this new API GMP pre-dates the ICH activity itself.

His 50-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.

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.

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, Foods and Food Additives, Nutritional Supplements, laboratory, documentation, sterile and oral dosage forms as well as devices, diagnostics and radiopharmaceuticals.


 Webinar Id: LSHCML002
 6 months unlimited
 Duration 75 mins
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FDA GMP Requirements for API (Active Pharmaceutical Ingredients) - Just what do YOU need to do?

While this topic may appear easily addressed, appearances can be deceiving. This program will examine some history, real life experiences and discuss the real facts about GMP for Active Pharmaceutical ingredients. Just what is important to firms, producers of API and consumers of API. Discussed will be what regulations apply and what guidance is important. Also examined are various ICH and FDA guidance that enter the everyday business o........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCML001
 6 months unlimited
 Duration 75 mins
Ratings:
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Outsourcing and/or Purchasing API or Excipients - An Examination of Quality/Business Issues you should consider!

This program examines considerations that are important to firms that are considering if they should produce, outsource, or purchase API. The steps discussed during this program also have application to Excipients that are used by drug product producers. The subject has both Quality and Business implications which are important to a corporate plan's success. It discusses risks and benefits associated with these decisions and what a plan........

$167 Recorded (6 months unlimited access)


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