Pharma cGMP Utility Systems Management

Pharma cGMP Utility Systems Management 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 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

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