Webinar on 2011 FDA Guideline on Process Validation

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 should you 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

• Compliance Personnel
• QA Personnel
• validation Personnel