Jose Mora, is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Co Read more
This webinar on Process Validation Requirements will go over the foundations of process validation, with an emphasis on going beyond compliance to achieve a robust process. Review of the fundamentals of process validation, with an emphasis on looking beyond compliance to achieve a robust process.
Course Objectives:
When applied correctly, process validation can result in higher process dependability, higher yields, and lower operating costs.
Course Outline:
• 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 You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
• Research & Development
• Quality Engineers and Auditors
• Manufacturing Engineers
• Quality Assurance & Quality Control Teams
• Operations Teams
• Document Control
• Device Development Teams
• Personnel involved in Verification and Validation planning, execution and documentation for devices
From Pharmaceutical, Medical Devices, Biotechnology, Clinical Trial and Clinical Research Companies
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