Process Validation for the 21st Century: How to Prepare for the FDA’s First Changes in Two Decades
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The FDA has mapped out a new approach to process validation that emphasizes statistical analysis and lifecycle testing. What the agency hasn’t mapped out is how you will find the time and money it’s going to take overhaul your entire operation.
Still, you don’t have a choice: For 20 years, if a batch tested out of spec, the SOP was simply to sample another batch or two. Now, that same practice could trigger a warning letter. So could problems with statistics, monitoring, intra-batch testing, documentation and flow charts. There’s never been more ways for things to go wrong.
That’s why you better be 100 percent clear about what the FDA expects before you start redrawing your processes and retraining employees.
And here’s where to start…
Prepare now for all-new process design, qualification and verification.
Discover your best defenses against warnings, sanctions and recalls
The FDA’s sweeping new rules require manufacturers to do far more than update process validation. Commercial manufacturers are being asked to implement a whole new environment of testing, sampling, documentation and statistical analysis. With hard work ahead — and all-new pitfalls — you must zero in on how to make the right changes to measure up to everything FDA inspectors expect to see.
In this vital 90-minute Encore presentation, regulatory authority Alex Kanarek draws on 30 years of industry experience to show you where to focus your time — and money.
Sign up your entire team to learn how and why your process validation must change, including:
- What the FDA now expects at each stage of the commercial manufacturing product lifecycle — process design, qualification and continued verification
- Exactly where additional monitoring, testing, sampling and documentation will now be required and how you can address these challenges
- How to apply quantitative statistical methods most effectively to confirm uniform product quality (inter- and intra-batch)
- How the FDA expects process validation to differ at each stage of manufacturing and what specific compliance steps are required
- How your approach to quality control must change, including new data and documentation needed to support the continued validation requirement
- How to address the challenge of applying “full quality unit” attention even to viral and impurity clearance studies performed on a small scale
- How to use the FDA’s new guidance on process flow charts to help assure compliance
- When you can release products before the entire process validation is completed
- How industry feedback can influence enforcement
Plus, you'll get an opportunity to address your specific concerns during the Q&A session.