Pharma cGMP Utility Systems Management 2018

Topics

• 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

Who should Attend

• 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