October 2, 2024
Gillette Stadium

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Session 2: Audit Preparedness

2:00 PM – 2:45 PM | West Red Level, Suite 81

Audit Preparedness

In this presentation, Kneat Solutions™ Subject Matter Expert, Joe Azzarella, discusses the types of audits and inspections pharma companies can expect, how to prepare for them, what to do as the inspection is being carried out, and steps to be taken after the final report is delivered. He’ll also discuss how digital validation enhances audit readiness, streamlines inspection, and can lead to lasting positive relationships with regulators. -How digital validation supports preemptive audit readiness, auditor question responses, and can support in post-audit activities -The types of audits and how they differ -Best practices for companies while they are being audited.


Joe Azzarella, Customer Service Engineer, Kneat Solutions

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Joe Azzarella is a Six Sigma Black Belt and has 10+ years’ experience in lyophilization development, technology transfer, and process development for pharma and life sciences companies. An author of multiple papers and whitepapers, Joe has also guest lectured at Purdue University, appeared on webinars and podcasts, and currently works with Kneat Solutions to bring digital validation to life sciences leaders.