Develop a Process Validation Roadmap - Webinar CD/Transcript
Develop a Process Validation Roadmap: Case Studies Show How to Satisfy FDA’s Scrutiny
If you haven’t started revalidating your processes and using your change control SOPs, you’re headed for 483s and recalls that could cost millions of dollars.
Most drug and biologics manufacturers aren’t really sure how to comply with the FDA’s process validation (PV) guidance. Many don’t even want to apply the guidance to avoid having to revalidate their processes.
BONUS: Receive a customizable template document that will help you answer the FDA’s basic PV questions: How’d you get there? Can you prove your results in a repeatable manner? Show me what you’re doing going forward. This document has been used by drug and biologics companies, reviewed by FDA investigators and found acceptable.
The FDA has significantly changed its approach to process validation. You risk costly enforcement if you haven’t aligned your change controls, monitoring and trending efforts. Now, this 90-minute webinar helps you do it all with an easy-to-follow roadmap that has already helped companies with complex processes achieve compliance.
Process validation expert Rich Yeaton shares his road-tested “roadmap” — a template that will enable you to use your existing PV data to satisfy regulators. Plus, he’ll share case studies of how three companies like yours have used the roadmap successfully.
Order the webinar CD and transcript to get the know-how you need to map out your own fastest, surest route to PV compliance, including how to:
- Use Yeaton’s template to zero in on the statistics that matter — and avoid wasting time validating things that don’t matter
- Align your approach with the FDA’s own new approach with everything from change control SOPs to justifying changes in PV data
- Translate case studies into your own best practices for establishing credibility with FDA investigators as they review your data and procedures
- Understand how the nuances of the new FDA final guidance apply to you
- Implement a plan that covers all the bases — process design, qualification and continued verification — in exactly the way the FDA expects
- Follow a quick and easy format to be ready to present FDA auditors with an Executive Summary of your process validation
- And more