2011 FDA Guideline on Process Validation - Webinar

  • ID: 4428068
  • Webinar
  • 60 Minutes
  • NetZealous
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The FDA in 2011 instituted its latest interpretation. Many have not chosen to take it seriously or change their business model. The paradigm has shifted and this presentation will articulate what has changed and how we need to react. Validation as derived from industry practice has a new spin. This presentation will take you through that development and demonstrate how some in the industry have reacted to the new expectations.

Why You Should Attend: This is a topic very near and dear to those who are involved with qualification and validation. Of all the topics regarding compliance this subject area has to be the most re-invented. Those in attendance will hear how to approach the topic and what some companies are currently doing to meet the expectation. If you are new to the topic or just want to learn more regarding this evolving area of compliance then consider attending this session.

Areas Covered in the Session:

What it means
What it says
What is in and what is out
Comparison of what has changed
PPQ1 and PPQ2
What is PV
What is Qualification
ASTM 2500
European interpretation
Inconsistencies
Hybrid compliance
Hyper-care
The 3X rule
What is validation and what is not
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  • Louis Angelucci Louis Angelucci,


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  • Compliance Personnel
  • QA Personnel
  • validation Personnel
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