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Vice President, Quality & Regulatory Affairs
Speaker BioMr. Brandreth brings over twenty years of experience in the regulatory and quality assurance fields for the biotechnology and pharmaceutical industries. Prior to joining Althea Technologies he was Vice President of Quality at Favrille, Inc., where he had oversight of QC, QA, Validation and Metrology. He has managed the validation of 11 biotech facilities over the past 17 years, and led the Process Validation Programs for five CBER/EMEA product launches. Previous to Favrille, Mr. Brandreth was Senior Director of Quality at BioMarin Pharmaceuticals, Inc. where he supported a variety of clinical and the launch of two commercial products. He held management positions in QA, Validation and Regulatory Affairs at IDEC Pharmaceuticals from 1992-1999, where he assisted in the development and launch of Zevalin' and Rituxan', CBER's first approved monoclonal antibody for cancer. He is an author of PDA TR 42, Process Validation of Protein Manufacturing, and is the Co-Chair of PDA TR 14, Validation of Chromatography Based Systems. He holds a BS in Biology and a Masters in Business Administration, was a Director for 10 years, President of ISPE, San Diego Chapter and current member of the Interphex Advisory Council Board.
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