If there is one truth shared across every inspection, whether in the US, Europe, or Asia-Pacific, it’s this: Audit readiness doesn’t depend on how well people repeat procedures. It depends on how well they understand them. Most organisations treat audit preparation as a last-minute exercise: refresh the SOPs, rehearse a few storyboards, tidy up documentation,…
Audit Readiness Is Not a Training, It’s a Culture Read More »
Conversations That Matter No deviation’s Takeaways from ISPE France Conference – Outsourcing and Supplier Management in the Pharmaceutical Industry Speaker: Jean-Denis Mallet – Former Inspector, Auditor, and Trainer With over 350 inspections and 300 audits under his belt, the speaker offers a unique dual lens—one forged in the rigour of regulatory enforcement, the other in the
Outsourcing of GMP Audits: Practical and Regulatory Aspects Read More »
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