Good Manufacturing Practices for Manufacture of Biopharmaceutical Products
Online Training Id: GMP-006
Geographical Region: Global
Level: Intermediate
Duration: 2 hrs 30 mins
This eLearning lecture provides an overview of the Regulations and Guidelines governing the production of sterile products by aseptic processing and defines the process controls, personal behaviour, cleaning and validation that need to be in place to assure the sterility of the product.
Learning Objectives:
The course will provide an understanding of the Aseptic production process, and the monitoring systems require to mitigate the risks and controls necessary to assure the sterility of the completed product. Delegates completing this eLearning course will have a clear understanding of;
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Regulations and Guidelines
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Aseptic Processing
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Personal Behavior
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Aseptic process controls
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Cleaning and Process Validation
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Special Consideration for Aseptic Processing
All persons involved in the production of Sterile products by aseptic production techniques.
Author:
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.