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!

Level: Fundamental
ISPE CEUs: 2.0
Type: Classroom Training Course

ISPE GAMP Logo

This Classroom training course has been updated to include the new revised EU GMP Annex 11, and an update on 21 CFR Part 11.

This three-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.

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.

Course Topics Include:

  • 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
A Risk-Based Approach to Compliant GxP Computerized Systems cover

Immediately apply the course learning objectives with a complimentary copy of the bound GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems Guide.

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

Take Back to Your Job

  • Understand the FDA and EU Regulatory requirements for GxP Computerized systems
  • Overview of GAMP5 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

Attendance Suggested for:

  • 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

Community of Practice (COP)

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

  • May 28, 2018 - May 30, 2018
    Barcelona Spain

    Daily Schedule

    Daily Schedule at a Glance
    08.00 – 17.00 Registration Open
    09.00 – 17.00 Training Course
    10.30 – 11.00 Refreshment Break
    12.30 – 13.30 Lunch
    15.00 – 15.30 Refreshment Break

    Instructors

    Director

    Fees

    Type
    Early
    Before
    19 Mar
    Regular
    19 Mar -
    17 Apr
    Late
    After
    17 Apr
    Member
    2,493.00
    2,614.00
    2,735.00
    Nonmember
    2,923.00
    3,044.00
    3,165.00
    Government
    908.00
    908.00
    908.00

    Group Discounts

    • 3 - 5 participants - Save 10%
    • 6 - 10 participants - Save 15%
    • 11 or more participants - Save 20%

    To qualify, all registrant information must be submitted at the same time. Only ONE payment to cover all registrations will be accepted. 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.

  • September 24, 2018 - September 26, 2018
    Bethesda, MD United States

    Daily Schedule

    Daily Schedule at a Glance
    08.00 – 17.00 Registration Open
    09.00 – 17.00 Training Course
    10.30 – 11.00 Refreshment Break
    12.30 – 13.30 Lunch
    15.00 – 15.30 Refreshment Break

    Fees

    Type
    Early
    Before
    17 Jul
    Regular
    17 Jul -
    15 Aug
    Late
    After
    15 Aug
    Member US$
    2,185.10
    US$
    2,285.02
    US$
    2,385.03
    Nonmember US$
    2,580.01
    US$
    2,680.02
    US$
    2,780.03
    Government US$
    900.01
    US$
    900.02
    US$
    900.03

    Group Discounts

    • 3 - 5 participants - Save 10%
    • 6 - 10 participants - Save 15%
    • 11 or more participants - Save 20%

    To qualify, all registrant information must be submitted at the same time. Only ONE payment to cover all registrations will be accepted. 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.

  • October 01, 2018 - October 03, 2018
    New Brunswick, NJ United States

    Daily Schedule

    Daily Schedule at a Glance
    07.30 – 17.00 Registration Open
    08.30 – 17.00 Training Course
    10.00 – 10.30 Refreshment Break
    12.00 – 13.00 Lunch
    14.30 – 15.00 Refreshment Break

    Instructors

    Consultant

    Fees

    Type
    Early
    Before
    23 Jul
    Regular
    23 Jul -
    22 Aug
    Late
    After
    22 Aug
    Member US$
    2,185.00
    US$
    2,285.00
    US$
    2,385.00
    Nonmember US$
    2,580.00
    US$
    2,680.00
    US$
    2,780.00
    Government US$
    900.00
    US$
    900.00
    US$
    900.00

    Group Discounts

    • 3 - 5 participants - Save 10%
    • 6 - 10 participants - Save 15%
    • 11 or more participants - Save 20%

    To qualify, all registrant information must be submitted at the same time. Only ONE payment to cover all registrations will be accepted. 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.

  • October 15, 2018 - October 17, 2018
    Boston, MA United States

    Daily Schedule

    Daily Schedule at a Glance
    08.00 – 17.00 Registration Open
    09.00 – 17.00 Training Course
    10.30 – 11.00 Refreshment Break
    12.30 – 13.30 Lunch
    15.00 – 15.30 Refreshment Break

    Instructors

    Sr. Project Manager

    Fees

    Type
    Early
    Before
    6 Aug
    Regular
    6 Aug -
    5 Sep
    Late
    After
    5 Sep
    Member US$
    2,185.00
    US$
    2,285.00
    US$
    2,385.00
    Nonmember US$
    2,580.00
    US$
    2,680.00
    US$
    2,780.00
    Government US$
    900.00
    US$
    900.00
    US$
    900.00

    Group Discounts

    • 3 - 5 participants - Save 10%
    • 6 - 10 participants - Save 15%
    • 11 or more participants - Save 20%

    To qualify, all registrant information must be submitted at the same time. Only ONE payment to cover all registrations will be accepted. 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.

  • December 05, 2018 - December 07, 2018
    Bethesda, MD United States

    Daily Schedule

    Daily Schedule at a Glance
    07.30 – 17.00 Registration Open
    08.30 – 17.00 Training Course
    10.00 – 10.30 Refreshment Break
    12.00 – 13.00 Lunch
    14.30 – 15.00 Refreshment Break

    Instructors

    Sr. Project Manager

    Fees

    Type
    Early
    Before
    26 Sep
    Regular
    26 Sep -
    26 Oct
    Late
    After
    26 Oct
    Member US$
    2,185.00
    US$
    2,285.00
    US$
    2,385.00
    Nonmember US$
    2,580.00
    US$
    2,680.00
    US$
    2,780.00
    Government US$
    900.00
    US$
    900.00
    US$
    900.00

    Group Discounts

    • 3 - 5 participants - Save 10%
    • 6 - 10 participants - Save 15%
    • 11 or more participants - Save 20%

    To qualify, all registrant information must be submitted at the same time. Only ONE payment to cover all registrations will be accepted. 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.