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.
Areas Covered in the Session:
Global Harmonization Task Force requirements (includes FDA and ISO)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Facilities and utilities
Strategies for achieving a robust and reliable process
Typical process validation protocols
Who Will Benefit: Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
Research & Development
Quality Engineers and Auditors
Quality Assurance & Quality Control Teams
Device Development Teams
Personnel involved in Verification and Validation Planning, Execution and Documentation for Devices
Jose Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José 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.