Peter Berzins Eli Lilly

Peter Berzins is currently a Senior Director – Global Quality Systems for Eli Lilly and Company. He is responsible for external monitoring, establishing, and oversight of Lilly’s Global Quality Standards for Production Practices, Validation, and Sterility Assurance. In addition, he leads Lilly’s Annex 1 Global Team for the external engagement and commenting during the draft commenting periods and Lilly’s global implementation of Annex 1 across all Lilly manufacturing.

Mr. Berzins holds an undergraduate degree in Bio-medical Engineering from Marquette University in Milwaukee WI and an MBA from Meredith College in Raleigh NC. He has over 31 years of operational, engineering, quality, and leadership experience in the US Navy and Pharmaceutical industry, including 25 years of Parenteral and Device manufacturing experience. Mr. Berzins’ roles have included project and technical leadership of several parenteral manufacturing facility design, construction, commissioning and qualification, start up and regulatory approval projects. In addition, he has supported and led several parenteral and device manufacturing operations. Finally, he has implemented several education, training, qualification and career progression programs in engineering, quality, and operational roles. Mr Berzins has been a PDA member for nearly 25 years and is active in various interest groups including Annex 1 Implementation, Facilities and Engineering, Filtration, and Sterile Processing / Parenteral Drug Manufacturing.