Managing EMA Drug Process Validation Comparing and Contrasting the EMA and FDA’s Process Validation Guidelines

Held Aug. 29, 2012

If the EMA drug process validation inspectors visited tomorrow, would you pass or fail?

Whatever your answer, please read on ...

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When it comes to regulating drugmaking, here’s the thing to know about Europe:

It’s not the U.S.

Superficially, EMA and FDA rules may seem similar. But differences abound, many subtle.

On April 12, the EMA published its highly anticipated draft guideline for drug process GMPs. The EMA draft, which supersedes the 2001 Note for Guidance on Process Validation, embraces the life-cycle approach embodied in the FDA’s 2011 process validation guidance.

A key feature of the EMA draft is a new approach called Continuous Process Verification (CPV) that supplants the old life-cycle approach.

FDAnews invited an international drug manufacturing consultant to bring you up to speed. Thomas Peither is a specialist in GMP training, validation and audits. His firm serves clients from offices in King of Prussia, PA, and Germany.

In a mere 90 minutes, you’ll gain an in-depth understanding of how to fulfill process validation requirements in both Europe and the U.S.

All listeners receive two essential analysis tools at no additional cost:

  • Side-by-side commented comparison of the 2012 EMA Process Validation Draft Guideline vs. the FDA 2011 Process Validation Final Guidance. This three-column worksheet shows at-a-glance the similarities and differences between EMA and FDA approaches.
  • Side-by-side comparison between the 2008 FDA Process Validation 2008 draft guidance vs. the 2011 final guidance, with important changes highlighted.

Must you throw out processes that have been in place for years? What, if anything, can be salvaged? By the end of this session, you’ll have the answers, and know the next steps to implementing this new process validation approach.

You’ll discover what European expert authorities expect — today, and tomorrow, too.

Perhaps best of all, you don’t need to fly to Germany.

You and your colleagues can listen from the comfort of your own office, conference room or auditorium. No planes, no hotels, no precious time away from work and family — just 90 minutes of solid learning.

Drugmaking is a global business. Don’t risk losing European customers by falling behind the regulatory curve. Sign up today for Managing EMA Drug Process Validation. Order now.

Here’s a suggested list of potential participants from your organization:

  • Quality Assurance Executives
  • Quality Management Executives
  • Manufacturing Executives
  • Quality Control Executives
  • Service Provider Executives
  • Senior Consultants

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Thomas Peither is President of Maas & Peither America, Inc., a consultancy specializing in compliance, risk management and governance in the health care industry. He is a specialist in qualification/validation in drug manufacturing and has developed tools for GMP training, qualifications, validations and audits. Prior to his current role, Mr. Peither was a project manager for the development of assembly lines and implementation of a continuous improvement process (Kaizen) in production at Stihl KG, Waiblingen, Germany and headed the business unit for pharma/chemicals/food at Josteit, Mölders and Partner Special Management Consulting GmbH, Düsseldorf, Germany. He is certified as a mechanical engineer.

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