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.
Qualification and Validation of Laboratory Equipment and Systems for Regulated Industries 2018 covers topics such as:
- 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
Qualification and Validation of Laboratory Equipment and Systems for Regulated Industries 2018 brings together 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
