GAMP® 5, Annex 11/Part 11 Basic Principles Training Course

Basic Principles of Computerized Systems Compliance Using GAMP® 5, Including Revised Annex 11 and Part 11 Update (T45) - Updated!

Overview

This training course includes the new revised EU GMP Annex 11, and an update on 21 CFR Part 11.

This two-day fundamental course* introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP® guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements.

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What You Will Learn

  • What are the FDA and EU regulatory requirements for GxP computerized systems?
  • Overview of GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems
  • The GAMP® system life cycle and specifications
  • Quality Risk Management for computerized systems
  • Practical Risk Assessment methods
  • Scalable specification and verification based on risk
  • Applying the GAMP® Categories in practice
  • Role of users and suppliers - assessment and cooperation and leveraging supplier activities and documentation, including Cloud Service Providers
  • Testing in GAMP® - principles and practical approaches
  • How to maintain compliance during the Operational Phase
  • Applying GAMP® 5 Principles to Legacy and existing Non-Validated Systems
  • Pragmatic and efficient practices - cost-effective compliance
  • Revised EU Annex 11 Computerized Systems, including the official GAMP® interpretation of key aspects
  • FDA 21 CFR Part 11 Update, including the current FDA interpretation, and how to meet these requirements in practical and effective ways

Resources and Activities

GAMP 5 Guide: Compliant GxP Computerized Systems

Course Modules

  • Regulatory Requirements
  • Overview of GAMP® 5
  • The Computerized System Lifecycle in Detail
  • User and Supplier Roles
  • Quality Risk Management and Detailed Risk
  • Testing of Computerized Systems
  • Operational Phase Activities
  • Effective and Efficient Compliance
  • Applying GAMP 5 to Legacy Systems
  • Introduction to data integrity
  • European Requirement
  • Part 11 Background, Scope and Application
  • European and International Requirements for Electronic Records and Signatures
  • Part 11 Requirements

Who Should Attend

  • Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers, MIS professionals and all levels of management who need a fundamental understanding of computerized system compliance and regulations
  • Computer system vendors or consultants, engineering contractors, and validation service companies

Additional Course Details

The course does not aim to cover detailed and highly technical aspects of software and hardware engineering, but rather gives the principles and an overview of the overall computer systems compliance process, including a scalable and efficient system lifecycle, Quality Risk Management, GAMP® categories, the role of the supplier, and the selection of appropriate specification and verification activities.

Learning Objectives

  • Understand the FDA and EU Regulatory requirements for GxP Computerized systems
  • Overview of GAMP® Guide: A Risk-based Approach to Compliant GxP Computerized Systems
  • The GAMP® system lifecycle and specifications
  • Infrastructure Qualification approaches
  • Quality Risk Management for Computerized systems
  • Practical Risk Assessment methods
  • Scalable specification and verification based on risk
  • Updated GAMP® Categories
  • Role of users and suppliers-assessment--cooperation and leveraging supplier activities and documentation (including outsourced and cloud solutions)
  • Testing in GAMP®-Principles and practical approaches
  • Pragmatic and efficient practices, cost-effective compliance
  • Applying GAMP® 5 principles to Legacy Systems
  • Revised EU Annex 11 Computerized Systems, including the official GAMP® interpretation of key aspects
  • FDA 21 CFR Part 11 Update, including the current FDA interpretation
  • A Risk-based approach to Electronic Records and Signatures to meet both FDA and EU Expectations

Communities of Practice

This training course is of particular interest to existing and future members of the GAMP® Community of Practice (COP).


Daily Schedule and Pricing

  • online-live
    Online Live
    - Online Live, United States
    15 - 16 Sep 2020

    Daily Schedule at a Glance

    Training times are listed in Eastern Standard Time (EST).
    Day 1
    0830 – 0845 Login & Registration
    0845 - 0900 Introductions
    0900 - 1030 Course Content & Exercise
    1030 - 1045 Break
    1045 - 1215 Course Content & Exercise
    1215 - 1300 Lunch
    1300 - 1430 Course Content & Exercise
    1430 - 1445 Break
    1445 - 1615 Course Content & Exercise
    1615 - 1630 Wrap-up, Questions & Discussions
    Day 2
    0830 – 0845 Login & Registration
    0845 - 0900 Recap
    0900 - 1030 Course Content & Exercise
    1030 - 1045 Break
    1045 - 1215 Course Content & Exercise
    1215 - 1300 Lunch
    1300 - 1430 Course Content & Exercise
    1430 - 1445 Break
    1445 - 1615 Course Content & Exercise
    1615 - 1630 Wrap-up, Questions & Discussions

    Featured Instructors

    Michael Byrd

    Former Director of CVS and CTO for ProPharma Group
    ProPharma Group

    Registration Fee

    REGULAR
    Member US$ 1,855.00
    Nonmember   US$ 2,155.00
    Government / Academia US$ 550.00
    Student US$ 90.00

    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.

  • online-live
    Online Live
    - Online Live, United States
    28 - 29 Oct 2020

    Daily Schedule at a Glance

    Training times are listed in Eastern Standard Time (EST).
    Day 1
    0830 – 0845 Login & Registration
    0845 - 0900 Introductions
    0900 - 1030 Course Content & Exercise
    1030 - 1045 Break
    1045 - 1215 Course Content & Exercise
    1215 - 1300 Lunch
    1300 - 1430 Course Content & Exercise
    1430 - 1445 Break
    1445 - 1615 Course Content & Exercise
    1615 - 1630 Wrap-up, Questions & Discussions
    Day 2
    0830 – 0845 Login & Registration
    0845 - 0900 Recap
    0900 - 1030 Course Content & Exercise
    1030 - 1045 Break
    1045 - 1215 Course Content & Exercise
    1215 - 1300 Lunch
    1300 - 1430 Course Content & Exercise
    1430 - 1445 Break
    1445 - 1615 Course Content & Exercise
    1615 - 1630 Wrap-up, Questions & Discussions

    Featured Instructors

    Registration Fee

    REGULAR
    Member US$ 1,855.00
    Nonmember   US$ 2,155.00
    Government / Academia US$ 550.00
    Student US$ 90.00

    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.