Beyond the Checklist
Beyond the Checklist
Podcast Description
“Beyond the Checklist” is a podcast that explores not only the essential aspects of cGMP but also explores the human factors that drive excellence in life sciences manufacturing. Through expert interviews, industry insights and real-world discussions, we uncover how culture, leadership and innovation shape a safer, more efficient path to market.
Join us as we navigate the complexities of regulatory requirements while highlighting the people and processes that elevate compliance from a box-checking exercise to a mindset of continuous improvement.
In the highly regulated world of pharmaceutical, medical device and biotechnology manufacturing, compliance is critical — but true quality goes beyond the checklist.
Podcast Insights
Content Themes
The podcast focuses on topics like regulatory requirements, culture in manufacturing, leadership, and innovation, with episodes exploring key areas such as automation's impact on quality, the role of AI in drug manufacturing, and the importance of data governance. For instance, the inaugural episode discusses pharma tech evolution with expert Mike Rutherford, highlighting his insights on the balance between regulatory expectations and practical risk.
“Beyond the Checklist” is a podcast that explores not only the essential aspects of cGMP but also explores the human factors that drive excellence in life sciences manufacturing. Through expert interviews, industry insights and real-world discussions, we uncover how culture, leadership and innovation shape a safer, more efficient path to market.
Join us as we navigate the complexities of regulatory requirements while highlighting the people and processes that elevate compliance from a box-checking exercise to a mindset of continuous improvement.
In the highly regulated world of pharmaceutical, medical device and biotechnology manufacturing, compliance is critical — but true quality goes beyond the checklist.
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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For more information, visit www.perfval.com.
#cGMPCompliance #FDARegulations #QualityAssurance #CQV
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