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.
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:
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
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.
Venue: Online / Webinar
Country: United States
Organiser Contact Details: