Critical Utility GMP Compliance

Critical Utility GMP Compliance Training Course (T65)

Overview

This new course is focused on how to be compliant in the design, operation & qualification of critical utilities and how to prove it. It comprises four modules including interactive case studies from real experience. This helps the participants to experience live discussions on compliance topics. The content is primarily based on the new ISPE Good Practice Guide “Critical Utilities GMP Compliance”. All content is held by contributing authors of the Good Practice Guide, so the participants get first-hand information from well-experienced trainers.

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What You Will Learn

  • Regulatory Perspective on Critical Utilities - Drinking Water, and PW and WFI
  • Regulatory Perspective on Critical Utilities - Pure Steam, Compressed Air, Medical Gases
  • Validation Life Cycle, Change Control, Risk Management, intro to a few risk assessment techniques
  • Quality Systems - Drawings and Docs, Investigation, CAPA, Trending
  • Rouging
  • Data Integrity, Handling and Automation
  • Sanitization and Sampling
  • Maintenance, Hoses, Routine System Review
  • Calibration and Training
  • Typical Warning Letters Review
  • Microbial Enumeration
  • Inspection Hosting Best Practices

Resources and Activities

Good Practice Guide: Critical Utilities GMP Compliance


Course Modules

  • Introduction & Regulatory
  • Validation Life Cycle & Quality Systems
  • Ongoing Operations
  • Legacy Water Systems

Who Should Attend

  • Project/Manufacturing Engineering resources engaged in utility projects
  • Quality assurance and quality control specialists, validation scientists, manufacturing supervisors, technical support personnel, engineers, and all levels of management involved in any type of critical utilities
  • Manufacturing personnel, technicians, scientists, and quality control specialists
  • People involved in audits and inspections
  • Personnel who need an in-depth understanding of the potential risks around utilities
  • Service organizations, suppliers, planners, and vendors who serve pharmaceutical industry Clients focused on critical utilities
  • Academic Institutions engaged in pharmaceutical development/manufacturing
  • Vendors and Suppliers of equipment/systems focused on critical utilities

Additional Course Details

Learning Objectives:

  • Background and impact of critical utilities
  • Understanding the necessary amount of GMP compliance when operating Critical Utilities
  • Understanding of regulatory requirements
  • Understanding how to act and react in inspections, do’s and don’ts
  • Understanding how to reliably operate critical utilities
  • How to keep up compliance in legacy systems

Communities of Practice

This training course will be of particular interest to:

  • Existing members of the Biotech Critical Utilities CoP
  • Existing members of the Biotechnology CoP
  • Members focused on manufacturing risk assessment/mitigation
  • Quality assurance and quality control specialists, validation specialists

Daily Schedule and Pricing

This course is not currently scheduled, but may be offered at your company site. Please contact ISPE for more information