Host Robert Perks speaks with Charlie Wakeham, Director at WakeUp to Quality and Chair of the ISPE GAMP Global Steering Committee. Charlie gives us the origin story of GAMP, including the tragic failures that underscored its necessity, and offers insight into how GAMP 5 Second Edition is helping teams move from documentation-heavy routines to risk-based, value-driven validation. She explains how GAMP supports innovation when applied with critical thinking and expertise, from AI to cloud platforms. This conversation is fascinating for professionals building a culture of intrinsic compliance and continuous improvement.
Key Takeaways:
(04:54) GAMP emerged from real-world failures and the urgent need for safer computerized systems.
(06:07) Validation is now expected, but quality execution remains inconsistent across the industry.
(09:25) GAMP 5 Second Edition promotes a risk-based, critical-thinking approach to validation.
(12:36) Intrinsic compliance is achieved through leadership, governance, and strong data integrity practices.
(14:42) Validation should be a strategic tool to ensure return on investment and patient safety.
(18:02) Adoption of AI and ML requires caution, transparency, and human oversight to ensure safe outcomes.
(22:54) Commissioning and qualification should align with validation as part of one continuous process.
(25:37) Empowering future professionals means moving beyond checklists and fostering independent, critical thinking.
Resources Mentioned:
https://www.linkedin.com/in/charliewakeham/
WakeUp to Quality | LinkedIn
https://www.linkedin.com/company/wakeup-to-quality/
WakeUp to Quality | Website
https://wakeuptoquality.com/
International Society for Pharmaceutical Engineering (ISPE) Website
https://ispe.org/
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