Pharma cGMP Utility Systems Management 2018 is a workshop that covers topics such as:
- FDA and USP vocabulary and Terminology
- Effective Installation/Operation Process Systems
- FDA Inspection Readiness – Are You Prepared? Do you Know what is expected?
- Lifecycle Approach to Maintaining a State of Validation
- Validation Considerations for Multi-Products Transfer to Manufacturing Facilities
- Emerging Regulations and Enforcement Trends in cGMP Utilities and Prevention of Problems That could shut down the systems
- User Requirements and Implementation of a Risk-Based, Compliant Management System
Pharma cGMP Utility Systems Management 2018 brings together:
- Quality Control Personnel and Management
- Quality Assurance Personnel and Management
- Process Engineering Personnel and Management
- Regulatory and Compliance Personnel and Management
- Facility Engineering Personnel and Management
- Utility Engineering Personnel and Management
- Validation Personnel for Water System Qualification
- Manufacturing Personnel and Management
- Testing Analysts and Technicians
- Laboratory Managers
- Microbiologist Personnel and Management