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Process Validation Requirements & Compliance Strategies

Duration : 60 Minutes

Jose Mora,

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


All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records.

Utilizing suppliers as an extension of an organization´s design and manufacturing capabilities presents unique challenges.

Background:

This Process Validation Requirements webinar 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.

Why Should You Attend:

When used as intended, process validation can provide increased process reliability, improved yields, and reduced operating expenses.

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

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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