Develop a Process Validation Roadmap Case Studies Show How to Satisfy FDA’s Scrutiny
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An FDAnews
Webinar Rebroadcast
Recent reports from FDA-inspected sites suggest that all FDA inspectors want to do is talk about process validation.
Mark your calendar for Wednesday, Nov. 28, when we’ll rebroadcast Rich Yeaton’s February webinar.
Here’s what our satisfied registrants had to say on what they liked about this webinar:
- “Innovative, specific points, no dancing around the point.”
- “Clear and concise language. Presenter was well qualified.”
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. Last year’s process validation (PV) guidance is both daunting and difficult.
Most drug and biologics manufacturers aren’t really sure how to comply with the new PV guidance. Many don’t even want to apply the guidance to avoid having to revalidate their processes.
SPECIAL BONUS for Attendees Attendees will 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.
Register now 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
A flexible fit for your busy schedule
The webinar rebroadcast, Develop a Process Validation Roadmap is convenient to attend. All that’s required is that you be in front of a computer monitor at the appointed time, whether you’re at the office or telecommuting from your office-in-home.
From process owners and engineers to quality, manufacturing, project, operations and validations managers, everyone on your team will benefit from taking part in this event. Best of all, everyone can attend at a cost that won’t break the budget.
You pay one single low registration fee per facility, regardless of how many participate. So spread the word to your team!
Sign up for Develop a Process Validation Roadmap: Case Studies Show How to Satisfy FDA’s Scrutiny today. Please note; this webinar has been previously recorded and no questions will be taken during the presentation.