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)
- Design Qualification
- Facilities and utilities
- Strategies for achieving a robust and reliable process.
- Typical process validation protocols
Who Should Attend:
- Research and Development Departments
- Engineering Departments
- Quality Departments
- Manufacturing Departments
- Operations Departments
- Production Departments
- Document Control Professionals
- Device Development Teams
- Quality Auditors
- Personnel involved in Verification and Validation planning, execution and documentation for devices