Dr. Gary Bird Ph.D.

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.

Other Online Trainings Provided:
  1. Good Manufacturing Practices for Manufacture of Biopharmaceutical Products
  2. Introduction to GMPs
  3. What to expect from a GCP audit/inspection?
  4. Requirements of Master & Working Cell Banks for Biopharmaceuticals manufacture
  5. Cell Culture – the Basis for Biopharmaceuticals / Biosimilars
  6. Good Manufacturing Practices for Manufacture of Biopharmaceutical
  7. Specifications for Biopharmaceuticals
  8. Stability Testing of Biopharmaceuticals
  9. Characterisation of Biopharmaceuticals
  10. Introduction To Biosafety
  11. Biotech Manufacturing processes to produce Biopharmaceuticals
  12. Aseptic Processing of Biopharmaceuticals
  13. Manufacturing Facilities Required for a Biopharmaceutical Production
  14. Stability of Biopharmaceutical Products
  15. Specifications of Biopharmaceutical Products
  16. Biosafety for Biopharmaceutical Manufacture
  17. Cell bank characterization for manufacture of Biopharmaceuticals