The Challenge of CMC Regulatory Compliance for Biopharmaceuticals (2nd Ed., 2nd ed. 2013)
John Geigert is President of BioPharmaceutical Quality Solutions, which specializes in providing CMC regulatory strategy consulting for the biopharmaceutical and biologic industry. Dr. Geigert has over 35 years of CMC industrial experience and leadership in the biopharmaceutical industry. Dr. Geigert has served on the PDA Board of Directors, co-chaired the PDA Biotech Advisory Board and served as an expert member of the USP Biotechnology Committee. Dr. Geigert has written extensively for the Regulatory Affairs Professional Society (RAPS) Focus (What Senior Management Needs to Know About CMC Regulatory Compliance for Biotech Products (Aug-Nov 2009, 4-part series) and Demystifying CMC Regulatory Strategy (Sept 2011-Mar 2012, 4-part series)).
Highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment
Presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing
Revised 2nd Edition is broadened to include biopharmaceuticals (biotech drugs) and other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)
Includes supplementary material: sn.pub/extras
Date de parution : 08-2016
Ouvrage de 338 p.
17.8x25.4 cm
Date de parution : 05-2013
Ouvrage de 338 p.
17.8x25.4 cm
Mots-clés :
2nd Edition; Biopharmaceuticals; CMC; Geigert; Regulatory Compliance