Good Manufacturing Practices for Manufacture of Biopharmaceutical Products
Online Training Id: GMP-002
Geographical Region: Global
Duration: 2 hrs 30 mins
This lecture will demonstrate that Biopharmaceutical manufacturing processes are highly product specific and almost always designed to fit the Biopharmaceutical molecule and provides the delegate with the following skills.
A specific scientific knowledge of Biopharmaceuticals manufacture
The techniques used in Biopharmaceutical Manufacture
The Equipment necessary to manufacture Biopharmaceuticals
To introduce the principles of GMPs as they relate to biopharmaceuticals. To present the responsibilities of Manufacturing Operations and Quality Assurance in the biopharmaceutical manufacturing facility, on comlpeting this course the delegate will have a good understanding of;
Regulatory Standards for GMP Compliance
Roles of Production and Quality Organizations
A brief discussion on the process and its control
The importance of preventing contamination.
Thomas G. (Gary) Bird, Ph.D. is co-founder of PharmaConsult Global, Ltd., an international cooperative supplying GXP quality consulting services and President, PharmaConsult-US, LLC. He served as Director of Corporate Quality for GTx, Inc. (Memphis, TN, USA) from 2003 until 2013 and was responsible for confirming all non-clinical (GLP), manufacturing (GMP), and clinical trial (GCP) related activities were conducted in compliance with appropriate laws and regulations.
He developed all Quality Systems to support the growth of the small pharmaceutical company and led an NDA submission team. Prior to joining GTx, he was with Eli Lilly and Company from 1995 to 2003, serving as Senior Quality Advisor for Biotechnology in Corporate Quality Assurance and Senior Regulatory Consultant, CMC Regulator Affairs.
He was with the FDA from 1990 to 1995 in both CDER and CBER where he was Assistant to the Deputy Director. During his time with Lilly and FDA he represented both PhRMA and the FDA in the International Conference on Harmonization negotiations on four (4) different agreed guidances.
He approved and signed documents on behalf of both organizations. He was secretary for all ICH Working Committees for documents on which he worked including Biotech Stability (Q5C), Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process (Q5E); Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (Q6B) and The Common Technical Document for CMC Submissions (M4). Dr. Bird holds a Ph.D. in Biochemistry/Entomology from Mississippi State University.
Dr. Gary Bird PH.D.