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

  • online-live
    Online Live
    29 Nov 2021 - 2 Dec 2021

    Daily Schedule at a Glance

    Training course times are listed in Eastern Standard Time (EST). Find your personal viewing time on the World Clock.

    0830 – 0845 Login
    0845 - 0900 Introductions
    0900 - 1030 Course Content & Exercise
    1030 - 1045 Break
    1045 - 1215 Course Content & Exercise
    1215 - 1230 Wrap-up, Questions, Discussion
    0830 – 0845 Login
    0845 - 0900 Recap
    0900 - 1030 Course Content & Exercise
    1030 - 1045 Break
    1045 - 1215 Course Content & Exercise
    1215 - 1230 Wrap-up, Questions, Discussion
    0830 – 0845 Login
    0845 - 0900 Recap
    0900 - 1030 Course Content & Exercise
    1030 - 1045 Break
    1045 - 1215 Course Content & Exercise
    1215 - 1230 Wrap-up, Questions, Discussion
    0830 – 0845 Login
    0845 - 0900 Recap
    0900 - 1030 Course Content & Exercise
    1030 - 1045 Break
    1045 - 1215 Course Content & Exercise
    1215 - 1230 Wrap-up, Questions, Discussion

    Featured Instructors

    Registration Fee

    REGULAR
    Member US$ 1,685.00
    Nonmember   US$ 1,985.00
    Government / Academia / Emerging Economies* US$ 550.00
    Student* US$ 90.00
    *ISPE Membership is required for these registration rates.

    Now Your Whole Team Can Participate in an ISPE Learning Experience

    • 3 - 5 participants - Save 10%
    • 6 - or more participants - Save 20%

    Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, ask@ispe.org.


    Cancellations/Refunds

    Cancellations must be made in writing. If cancellations are received by 60 days prior to event start date, a full refund, minus a $150 handling fee, will be issued. After that time, no refunds will be granted. Please be advised that if your payment or written cancellation notice is not received prior to the cancellation date, your credit card will be charged the prevailing rate. Refund requests must be in writing and emailed or faxed to +1 (813)-264-2816. (Telephone messages are not accepted). ISPE reserves the right to modify the material or presenters for this event without notice, or cancel an event. If an event must be canceled, registrants will be notified by ISPE. ISPE will not be responsible for airfare penalties or other costs incurred due to cancellation.