Qualification and Validation of Laboratory Equipment and Systems for Regulated Industries 2018

Qualification and Validation of Laboratory Equipment and Systems for Regulated Industries 2018 is a workshop dedicated to requirements of both Validation and Qualification activities in Pharma.

Topics

• Examples of Regulatory Enforcement Actions
• Qualification and Validation in Regulated laboratories
• Product Life Cycle and sharing of responsibilities between Vendor and the User
• Risk Based Strategy
• Master Validation Plan
• Integration with Quality System
• Examples of select Equipment /Systems
• Group Exercise: Develop Qualification Strategy and Master Validation Plan
• Discussion on guidance from USP on analytical instrument qualification
• Training Issues
• Discussion on testing and acceptance criteria

Who should Attend

Attendees from:

• Quality Assurance Departments
• Research and Development Departments
• Validation Departments
• Quality Control Departments
• Process Development Personnel
• Production Departments
• Compliance Departments
• Regulatory Departments
• Technicians Study Directors (GLP)
• Scientists and Chemists
• Pharmaceutical Development
• Qualified Persons (EMEA)
• Accredited Laboratories in general
• CRO Directors and Managers
• Everyone engaged with Test Methods