BIOTECH2007.pptVIP

Quality and Compliance Challenges for Biopharmaceutical Products Ramon Rivera Gonzalez, Ph.D. Director Quality Assurance Amgen Manufacturing, Limited Outline Background Information Regulatory and Process Challenges Quality by Design Risk Management Process Analytical Technology Key Quality Systems Deviations/Nonconformities Corrective and Preventive Actions Biological Product Deviations FDA and EMEA Observations Biotechnology Biotechnology is a set of scientific techniques used to derive valuable products from living organisms Applications biopharmaceutical drugs agriculture waste ma