Develop a Process Validation Roadmap - Webinar CD/Transcript
Develop a Process Validation Roadmap: Case Studies Show How to Satisfy FDA’s Scrutiny
A QA/QC expert has come up with a “roadmap” to steer you through the FDA’s complex of steps and guidelines surrounding process validation.
Meet Kelly Thomas, VP-Quality at Atlantic Technical & Validation Services. She boasts 18 years’ experience developing, implementing and managing QA/QC activities affecting cGMP operations in drug, biologics and device firms. In a mere 90 minutes, she’ll show you:
- Exactly what the FDA expects your process control strategy to include
- What your facilities designs should look like
- Qualifications of utilities and equipment at your facilities
- The process performance qualification and how it works
- What factors the Process Validation looks at
- Regulatory trends to be aware of
- And much more!
Prepare for hands-on learning, via case studies that apply principles learned to real-life problems in process validation.
You have enough on your plate without worrying about warning letters or Forms 483 resulting from a botched process validation submission. Don’t even risk it.