Robert D. Seltzer

Background

About Robert D. Seltzer

In Life Sciences permanent (FTE) or consulting/contractual roles: Direct teams and collaborate cross-functionally in all organizations to assure CGMP compliance with (i) FDA, EU/EMA, Health Canada, Japanese MHWA laws, directives, regulations, guidelines, marketing authorizations;(ii) relevant compendial chapters; and consensus standards Build on past accomplishments and cumulative experience in: Investigating manufacturing process deviations via multiple root cause analyses and, as necessary, human error analysis; verifying CAPA (corrective action and/or preventive action) completion, and effectiveness post-warning-letter and post-consent-decree Remediating or revamping quality systems and providing technical writing of new or revised standard operating procedures; providing training in CGMPs, self-inspection, and quality assurance auditing Auditing sterile, small-molecule, API/drug substance or finished drug product (FDP) manufacturing as well as biologic large-molecule manufacturing Conceptualizing then leading a committee of 25 domestic and international volunteer SMEs in developing a body of knowledge (BoK) for the American Society for Quality (ASQ) 2008 adoption of the Certified Pharmaceutical GMP Professional (CPGP) exam