Webinar On "Process Validation Requirements & Compliance Strategies"

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.

1. Global Harmonization Task Force requirements (includes FDA and ISO)
2. Installation Qualification (IQ)
3. Operational Qualification (OQ)
4. Performance Qualification (PQ)
5. Design Qualification
6. Facilities and utilities
7. Strategies for achieving a robust and reliable process.
8. Typical process validation protocols.

• 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

José Mora is a Principal Consultant and Project Manager specializing in Manufacturing Engineering, Quality Systems, and Lean Transformations. José is a recognized subject matter expert in process validation, lean manufacturing, lean controlled document systems, startup operations, process development and quality systems, having lectured internationally and presented webinars on these subjects.For over 30 years he has worked in the life sciences in positions ranging from Senior Engineer and Project Manager to Vice-President, specializing in manufacturing, process development, tooling, and quality systems. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles.

Wherever he has worked, Jose has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches. He has implemented various good manufacturing practices like JIT, kanban systems, visual workplace and lean manufacturing practices. Jose has also published a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.