Process Validation Requirements & Compliance Strategies for FDA Regulated Environment

Instructor: Jose Mora
Product ID: 700162
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

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This Process Validation Requirements webinar/training will Review process validation basics, with emphasis on looking beyond compliance towards achieving a robust process.

Review of process validation basics, with emphasis on looking beyond compliance towards achieving a robust process.When used as intended, process validation can provide increased process reliability, improved yields, and reduced operating expenses.

Areas Covered in the Session:

  • Global Harmonization Task Force requirements (includes FDA and ISO)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Design Qualification
  • Facilities and utilities
  • Strategies for achieving a robust and reliable process.
  • Typical process validation protocols.

What will Attendees Learn:

  • Process Validation strategies
  • Planning ahead for each protocol
  • How to incorporate DOEs and robust process methods into a process validation.
  • Checklists for IQ, OQ and PQ
  • Comparison of OQ and PQ with "old" OQ, Process PQ and Product PQ
  • Proper data recording for process validation

Who Will Benefit:

  • Manufacturing Engineers
  • Quality Engineers
  • Process Development Engineers and Scientists

Instructor Profile:

Jose Mora, is a Sr. Consultant at Streale as well as a partner in Atzari Consulting, LLC. Although he has been in the medical device industry for 24+ years in various companies, he has observed that the same types of issues and principles apply in all cases. Jose has worked as a Director of Manufacturing, Director of Manufacturing Engineering, Sr. Manufacturing Engineer, and as a Quality Systems Manager at companies such as V. Mueller (Cardinal Health), Cordis Corporation (J&J), Mentor Corporation, UroSurge (a startup urology products company), Boston Scientific, as well as several consulting clients. Jose has a BS. in Mechanical Technology from Purdue University.

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