Autoren

Lothar obtained his Diploma and Ph.D. in Technical Chemistry/Biotechnology from the Technical University of Berlin.

He joined Hoffmann-La Roche in 1988 and served in numerous functions in the global Quality Department. Lothar acted as “Head of External Relations”, interacting with regulatory health authorities and associations for more than a decade before being assigned as “Head of Knowledge Management”. He is now Head of Quality at Crucell Switzerland AG a Johnson & Johnson company.

He served for approximately 10 years on the board of APIC/CEFIC as Vice-Chairman. In this function he was nominated for the ICH Q7a Expert Working Group setting up world-wide harmonized GMPs for APIs. In this effort he also was FDA awarded in May 2004. Lothar is co- and lead-author of various documents published by CEFIC/APIC and EBE (European Biopharmaceutical Enterprises).

Lothar served as member in the “Board of Directors” of PDA (Parenteral Drug Association) and as chair of EBE's BioManufacturing Working Group. He is an expert in GMPs for APIs and ATMPs, Pharmaceutical Quality Systems and Knowledge Management.

Publications at Maas & Peither GMP Publishing

• GMP MANUAL
  (Author of chapter 1 Pharmaceutical Quality System)
• Pharmaceutical Quality System - PDF Download
  (Chapter 1 of the GMP MANUAL for Download)