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Validation, Change Control and Maintaining the Validated State

Validation, Change Control and Maintaining the Validated State

Implement a Compliant Program that has Immediate Impact

  • Instructor: Gamal Amer

  • Duration: 60 Min

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Managing changes in your Quality Management System is a FDA regulatory requirement. Change control is used as a risk mitigation tool and to maintain a validated state-of-control. This webinar guides you through a process of developing, implementing and maintaining a robust change control program enterprise-wide.

 

Top 10 Reasons to Attend:

  • Know the regulations, guidance and recommendations
  • Use change control as a tool to mitigate risk
  • Maintain compliance and a validated state
  • Understand the types of change and their potential impact
  • Learn the key components of a change control procedure
  • Outline of a robust change control procedure
  • Learn how to conduct an impact assessment
  • Know how to plan for Implementation
  • Implement change control and post change monitoring program
  • Receive a change control request form

 

Personnel in the Following Environments Should Attend:

  • Validation
  • QA/QC
  • Engineering
  • Regulatory Affairs
  • Compliance
  • Manufacturing
  • Laboratory

 

Gamal Amer

Ph.D., Principal, Premier Compliance Services, Inc.

Dr. Amer, a chemical engineer by training, has 40 years-experience in the pharmaceutical and related industries. He has held senior management positions with leading pharmaceutical, consumer products, and engineering consulting companies. His experience includes comprehensive process design in bulk pharmaceutical chemicals manufacturing, biotechnology manufacturing, pharmaceutical solid dosage manufacturing, and containment of potent and radioactive therapeutics. He is also experienced with facility development for therapeutic products operations. Dr. Amer is a recognized expert in GMP compliance and validation. He has lectured extensively in the US, Europe, Asia, and the Middle East and taught many courses on subjects such as controlled release technology, GMP trends, Validation and Change Control, and implication of GMP compliance on process and facility design in the biotechnology industry.

Education:

Ph.D. BioChemical Engineering, Virginia Polytechnic Institute & State University
M.S. Chemical Engineering, Virginia Polytechnic Institute & State University
B.Sc. Chemical Engineering, Cairo University

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