Develop a Process Validation Roadmap - Webinar CD/Transcript

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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.

  • QA/QC Personnel
  • Process Owners
  • Quality Managers
  • Quality Engineers
  • Manufacturing Managers
  • Manufacturing Supervisors
  • Manufacturing Engineers
  • Process Engineers
  • Development Engineers
  • Project Managers
  • Operations Managers
  • Validation Managers
  • R&D Personnel

Kelly Thomas is Vice President of 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, including developing and implementing Quality Systems consistent with strategic missions, customer expectations and regulatory requirements. Ms. Thomas holds an MBA from Meredith College and maintains several professional certifications from the American Society for Quality (ASQ).