Develop a Process Validation Roadmap Case Studies Show How to Satisfy FDA’s Scrutiny

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Back By Popular Demand!
An FDAnews
Webinar Rebroadcast

Recent reports from FDA-inspected sites suggest that all FDA inspectors want to do is talk about process validation.

Mark your calendar for Wednesday, Nov. 28, when we’ll rebroadcast Rich Yeaton’s February webinar.

Here’s what our satisfied registrants had to say on what they liked about this webinar:

  • “Innovative, specific points, no dancing around the point.”
  • “Clear and concise language. Presenter was well qualified.”

If you haven’t started revalidating your processes and using your change control SOPs, you’re headed for 483s and recalls that could cost millions of dollars. Last year’s process validation (PV) guidance is both daunting and difficult.

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

Register Today

SPECIAL BONUS for Attendees

Attendees will receive a customizable template document that will help you answer the FDA’s basic PV questions: How’d you get there? Can you prove your results in a repeatable manner? Show me what you’re doing going forward. This document has been used by drug and biologics companies, reviewed by FDA investigators and found acceptable.

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

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

A flexible fit for your busy schedule

The webinar rebroadcast, Develop a Process Validation Roadmap is convenient to attend. All that’s required is that you be in front of a computer monitor at the appointed time, whether you’re at the office or telecommuting from your office-in-home.

From process owners and engineers to quality, manufacturing, project, operations and validations managers, everyone on your team will benefit from taking part in this event. Best of all, everyone can attend at a cost that won’t break the budget.

You pay one single low registration fee per facility, regardless of how many participate. So spread the word to your team!

Sign up for Develop a Process Validation Roadmap: Case Studies Show How to Satisfy FDA’s Scrutiny today. Please note; this webinar has been previously recorded and no questions will be taken during the presentation.

This webinar rebroadcast 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

Rich Yeaton, president of East Coast Validation Services, LLC, has more than twenty years of experience working in FDA-regulated industries. He was initially introduced to GMP operations on the devices side as a development engineer in DuPont’s Medical Products Division. There, he developed and improved new process equipment and was told to validate what he had designed. He moved on to help start Phoenix Imperative, an engineering and validation consulting company serving the biopharmaceutical industry. A key achievement with Phoenix was leading validation teams at two MedImmune cell culture facilities to assist MedImmune to obtain its first two commercial licenses. He has since worked with small start-up companies and larger operating companies such as Merck, Genzyme, Wyeth and Lonza. He has in-depth experience with facility shutdowns and start-ups. Rich recently assisted Avecia Biologics, a microbial fermentation contract manufacturer, to successfully prepare for its first preapproval inspection held in January 2009. He is a member of the ASME, the ISPE and the PDA and has degrees in electrical engineering and mechanical engineering from Lehigh University.

Register now!

Date: Wednesday, Nov. 28, 2012
Location: Your office or conference room (no need to travel!)
Time: 1:30 p.m. – 3:00 p.m. EST
  12:30 p.m. – 2:00 p.m. CST
  11:30 a.m. – 1:00 p.m. MST
  10:30 a.m. – 12:00 p.m. PST
  6:30 p.m. – 8:00 p.m. GMT

Gather your team for maximum benefit! Your investment is for one dial-in.

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