Brian Belz

  PhotoBrian Belz has been a Compliance Officer for the FDA, within CDER’s Office of Compliance / Division of Manufacturing and Product Quality / International Compliance Branch (ICB) since 2008. Brian’s main responsibilities in ICB include reviewing and evaluating international inspection reports and collected evidence and recommending actions to be taken by FDA for firms failing to comply with applicable regulations. Belz is also a member of CDER’s Part 11 Working Group charged with re-evaluating Part 11 regulation and serves as a divisional expert in the areas of analytical chemistry, impurities, and OOS investigations. Prior to joining the FDA, Belz worked within large pharma which included several Merck & Co., Inc. facilities and positions. Brian’s industry experience covers: chemistry, such as in-process quality control and method development/validation; auditing, including documentation and facilities (manufacturing areas and laboratories); and global regulatory where he authored worldwide CMC submissions including INDs, NDAs and supplements. Belz educational degrees are in Chemistry and Physics from Lycoming College.