Avoiding the Pitfalls of Initial GMP Programming and Clinical Production Space Planning

  • Discussing the common pitfalls observed during establishment of initial GMP programs in the areas of quality systems, materials management, supplier qualification, etc.
  • How are companies adopting organizational changes and leveraging digital systems to avoid these pitfalls?
  • Important factors to consider when assessing build vs. buy for early-phase clinical production, and considerations for scaling a GMP program up and/or out
  • Illustrating the importance of establishing clear process requirements and conducting informal and formal facility fit assessments using real-world examples

Chris Mansur
President, Azzur Consulting
Azzur Group

Chris Mansur currently serves as the President of Azzur Group’s Consulting division, which specializes in providing innovative quality and compliance solutions to the life sciences industry. Throughout his career, Chris has specialized in new and renovated facility startups, project management, commissioning and qualification, computer validation, implementation of quality systems, and application of quality risk management principles. He is passionate about use of phase-appropriate GMPs to help companies solve problems that accelerate their product’s lifecycle or project timeline. Chris holds a bachelor of science degree in Mechanical Engineering from Worcester Polytechnic Institute.