Manufacturing Facilities Required for a Biopharmaceutical Production

Online Training Id: GMP-007

Geographical Region: Global

Level: Advanced

Duration: 1 hr 30 mins

This eLecture will provide you essential information for manufacturing facilities design given the critical nature the manufacturing process necessary for the manufacture of biopharmaceuticals.

Learning Objectives:

This lecture will detail the Manufacturing facilitates required for the production of Biopharmaceuticals, and will provide;

  • An Update on Regulations and Guidelines

  • Review of Facility design and control

  • Requirement for Cleaning Facility

  • Water Specification Requirements

  • Facility Environmental and Utilities Monitoring

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.

GBP $75.00

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