Process Validation Requirements & Compliance Strategies
Jose Mora is Keynote Speaker at ComplianceKey.He 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 Consulting, Jose served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. Duri........
Overview
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 this webinar?
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.
Who can 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
