Process Verification and Validation

MessageThis Webinar is over
Date Nov 14, 2018
Time (1:00 pm to 2:30 pm)
Cost $230.00
Online
This webinar will provide valuable guidance to regulated companies in development, implementation, or refinement of their manufacturing process verification and validation programs.

Why You Should Attend :
The FDA expects companies to perform meaningful, results driven manufacturing process validation, now including considering life cycle issues. While the company is held fully responsible for deciding how it will conduct process validation, alternate approaches require longer and more stringent documented rationale. Growing high-profile field problems indicate that validation and change control and its effect on regulatory review activities are not yet fully utilizing the power of current FDA guidance and associated tools, which must be a part of such an analysis.

Areas Covered in the Session :
  • Key process validation requirements
  • Current expectations
  • Recent process validation guidance documents
  • Lifecycle considerations
  • Expectations for the future as indicated by ICH Q7 and Q8
  • The “Controlled Process”

Who Will Benefit:
  • Senior Management
  • Regulatory Affairs
  • Quality Assurance
  • Production
  • R&D and Engineering
  • All personnel tasked with process verification and validation

 


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