Biopharmaceutical Development and Good Manufacturing Practice (GMP)

Package ID: GMP-PKG

Package Geographical Regions: Global

Level : Advanced

This course 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

Learning Objectives:

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.

Who Should Enroll:

  • Regulatory, Manufacturing, Distribution and Quality Assurance Staff.

This Package Include:

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;

  1. Introduction to Biopharmaceuticals and Biosimilar [Watch a Demo]

  2. Requirements of Master & Working Cell Banks for Biopharmaceuticals manufacture

  3. Cell bank characterization for manufacture of Biopharmaceuticals

  4. Biotech Manufacturing processes to produce Biopharmaceuticals

  5. Good Manufacturing Practices for Manufacture of Biopharmaceutical Products [Watch a Demo]

  6. Aseptic Processing of Biopharmaceuticals

  7. Manufacturing Facilities Required for a Biopharmaceutical Production

  8. Stability of Biopharmaceutical Products

  9. Specifications of Biopharmaceutical Products

  10. Biosafety for Biopharmaceutical Manufacture

Authors:

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.

John Dr Jolley FR PHARM S, FCQI CQP

 

 

 

 

 

 

John DR Jolley - FR Pharm S, FCQI CQP is a co-founder of Pharma Consult Global, a Pharmaceutical Consultancy providing technical consultancy and training European countries, Middle East, South Africa and the USA and involving International Pharmaceutical Experts from around the world.  He is a pharmacist who has held positions in Clinical Research, Product Registration, Pharmaceutical Manufacturing, Quality Assurance, and General Management.  He was Technical Director for Boehringer Ingelheim UK for 15 years before working in Technical consultancy. He is a practicing Qualified Person (QP) for pharmaceutical manufacturing, Distribution and Clinical Research organizations, and  is  an  Industry  representative  on  the  EMA  advisory  committees  for GMP/GCP.  John  has  a  degree  in  Pharmacy  and  has  been  awarded  fellowships  with  the  Royal Pharmaceutical Society and the Chartered Quality Institute.

GBP $750.00

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