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CODE: TWENTY20
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Validity : 06th May'25 to 16th May'25
Process Validation Requirements & Compliance Strategies
- 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.
Overview of the webinar
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.
Who should attend?
- 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
Why should you attend?
When used as intended, process validation can provide increased process reliability, improved yields, and reduced operating expenses.
Faculty - Mr.Jose Mora
Jose Ignacio 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 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. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.
Jose´ led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace, and lean manufacturing practices.