FDAnews Announces — Develop a Process Validation Roadmap: Case Studies Show How to Satisfy FDA’s Scrutiny Webinar, Sept. 9, 2015

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The FDA has significantly changed its approach to process validation and manufacturers risk costly enforcement if they haven’t aligned their change controls, monitoring and trending efforts. This webinar helps attendees do it all with an easy-to-follow roadmap that has already helped companies with complex processes achieve compliance.

Develop a Process Validation Roadmap:
Case Studies Show How to Satisfy FDA’s Scrutiny
**FDAnews Webinar**
Sept. 9, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/developprocessvalidationroadmap

The FDA has significantly changed its approach to process validation. Manufacturers risk costly enforcement if they haven’t aligned their change controls, monitoring and trending efforts. Now, this 90-minute webinar helps attendees do it all with an easy-to-follow roadmap that has already helped companies with complex processes achieve compliance.

Process validation experts Rich Yeaton and Kelly Thomas share their road-tested “roadmap” — a template that will enable manufacturers to use their existing PV data to satisfy regulators. Plus, they share case studies of how three companies have used the roadmap successfully.

Register now to get the know-how needed to map out the 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 an approach with the FDA’s own new approach with everything from change control SOPs to justifying changes in PV data
  • Translate case studies into own best practices for establishing credibility with FDA investigators as they review the data and procedures
  • Understand how the nuances of the new FDA final guidance apply
  • 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 the process validation
  • And more

Meet the Instructors:
Rich Yeaton, president of East Coast Validation Services, LLC, has more than twenty years of experience working in FDA-regulated industries. He has in-depth experience with facility shutdowns and start-ups. He is a member of the ASME, the ISPE and the PDA and has degrees in electrical engineering and mechanical engineering from Lehigh University.

Kelly Thomas is Vice President of Quality at Atlantic Technical & Validation Services. Ms. Thomas has 18 years of experience in the pharmaceutical, biotech, and medical device industries. Her area of expertise is in developing, implementing and managing all quality assurance and quality control activities affecting cGMP operations. Ms. Thomas holds a Bachelor of Science in Biology from East Carolina University and a Master's of Business Administration from Meredith College.

Who Will Benefit:
This webinar offers hands-on guidance of value to executives and personnel in drug, biologics, API and combination product operating companies, including:

  • 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

Conference Details:
Develop a Process Validation Roadmap:
Case Studies Show How to Satisfy FDA’s Scrutiny
**FDAnews Webinar**
Sept. 9, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/developprocessvalidationroadmap

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/developprocessvalidationroadmap
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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