GAMP® Data Integrity 21 CFR Part 11 Training Course

A GAMP® Approach to Data Integrity, Electronic Records and Signatures, and Operation of GxP Computerized Systems (T50) – New Course!

Overview

The importance and amount of data being generated to ensure product quality and patient safety continues to grow and proper controls around that data continue to be questioned. Regulatory agencies across the world are noticing a significant increase in data integrity issues. As a result, they are being forced to re-evaluate industry guidance and their enforcement strategies. Regulatory concerns and warning letters have extended to all areas of the pharmaceutical business, including manufacturing, development, clinical, pharmacovigilance and other areas of the product lifecycle. This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.

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What You Will Learn

This training course will provide a practical understanding of the following:

  • The current regulatory focus on Data Integrity
  • Relevant regulatory observations
  • Recent regulatory Guidance on Data Integrity
  • The need for Data integrity throughout the system and data life cycles
  • The requirement for a data governance framework
  • How to meet  the international regulatory requirements for electronic records and signatures
    • How to meet the requirements of 21 CFR Part 11 electronic records and signatures, including the FDA interpretation in the Scope and Application Guidance
    • How to meet the requirements of other relevant regulations including EU Annex 11
    • How to apply the current industry risk-based good practice approach to compliant electronic records and signatures
  • How to maintain Data Integrity through the operation phase of the GAMP life cycle
  • How new technologies such as cloud computing and mobile applications can impact data integrity
  • How to apply the new ISPE GAMP Guide: Records and Data Integrity including: 
    • Data Governance Framework
    • Culture and Human Factors
    • Data Life Cycle
    • Applying Quality Risk Management to Data Integrity

Resources and Activities

records and data integrity guide

Course Modules

  • Introduction
  • Data Integrity through the Lifecycle
  • MHRA Data Integrity Guidance
  • Regulatory Citations for Data Integrity
  • Data Governance
  • EU Annex 11 and Chapter 4
  • Compliant Operation of GxP Regulated Systems
  • 21 CFR Part 11 Electronic Records and Signatures
  • Data Integrity for Spreadsheets
  • Mobile Devices and Cloud Computing
  • ISPE GAMP Guide on Record and Data Integrity

Who Should Attend

  • All those working in a GxP regulated environment that require a working knowledge of data integrity, electronic records and signatures, and the associated operational aspects of GxP computerized systems.
  • Anyone who needs a fundamental understanding of the 21 CFR Part 11 regulation and risk management approaches to achieving electronic record and signature compliance.
  • Computer system vendors or consultants, engineering contractors, and validation service companies.
  • 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.

Additional Course Details

It is recommended that course participants have a basic awareness of GxP regulations and/or the use of computerized systems in a regulated environment. Some knowledge of the GAMP approach to computerized systems compliance would be an advantage.

Learning Objectives:

  • Understand the current regulatory focus on Data Integrity and the relevant regulatory observations
  • Review the new MHRA Guidance on Data Integrity
  • Analyze the need for Data Integrity throughout the life cycle
  • Evaluate the requirements for a robust data governance system
  • Know how to meet the requirements of 21 CFR Part 11 electronic records and signatures, including the USFDA interpretation in the Scope and Application Guidance, and international regulatory requirements for electronic records and signatures including Annex 11
  • Apply the current industry risk-based good practice approach to compliant electronic records and signatures
  • Understand approaches to cloud computing and mobile applications in the GxP environment
  • Understand the Key Concepts and approaches of the ISPE GAMP Guide on Record and Data Integrity

Community of Practice (COP)

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


Daily Schedule and Pricing

  • online-live
    Online Live
    12 - 13 Oct 2020

    Daily Schedule at a Glance

    Training times are listed in Central European Time (CET). Find your personal viewing time.

    World Clock

    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 / Emerging Economies 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
    19 - 20 Oct 2020

    Daily Schedule at a Glance

    Training times are listed in Eastern Standard Time (EST). Find your personal viewing time.

    World Clock

    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 / Emerging Economies 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.