FDAnews Announces — Develop a Process Validation Roadmap: Case Studies Show How to Satisfy FDA’s Scrutiny Webinar, May 28, 2014

If drugmakers haven’t started revalidating processes and using change control SOPs, they’re headed for 483s and recalls that could cost millions of dollars. In a 90-minute webinar process validation expert Rich Yeaton shares his road-tested “roadmap,” a template that will enable drugmakers to use existing PV data to satisfy regulators.

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FDAnews

FDAnews

Falls Church, VA (PRWEB) May 12, 2014

Develop a Process Validation Roadmap:
Case Studies Show How to Satisfy FDA’s Scrutiny
**FDAnews Webinar**
May 28, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/ProcessValidationRoadmap

If drugmakers haven’t started revalidating processes and using change control SOPs, they’re headed for 483s and recalls that could cost millions of dollars.

Most drug and biologics manufacturers aren’t really sure how to comply with the FDA’s process validation (PV) guidance. Many don’t even want to apply the guidance to avoid having to revalidate their processes.

The FDA has significantly changed its approach to process validation. Drug manufacturers risk costly enforcement if they haven’t aligned change controls, monitoring and trending efforts. Now, this 90-minute webinar helps 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 drugmakers to use existing PV data to satisfy regulators. Plus, he’ll share case studies of how three companies have used the roadmap successfully.

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

Meet the Instructor:
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.

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**
May 28, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/ProcessValidationRoadmap

Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register:
Online:     http://www.fdanews.com/ProcessValidationRoadmap
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.