GAMP® Basic Principles Training Course

Basic Principles of Computerized Systems Compliance: Applying the GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems (T07)

Overview

This classroom course has been updated to include the new revised EU GMP Annex 11, and an overview of 21 CFR Part 11.

This 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, by building upon existing industry good practice in an efficient and effective manner.

View Dates


What You Will Learn

  • What are the FDA and EU regulatory requirements for GxP computerized systems?
  • Revised EU Annex 11 Computerized Systems, including the official GAMP interpretation of key aspects
  • FDA 21 CFR Part 11 Overview, including the current FDA interpretation
  • How do investigators approach a computer systems inspection?
  • Overview of GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems
  • GAMP system lifecycle and specifications
  • 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 and cooperation and leveraging supplier activities and documentation
  • Testing in GAMP - principles and practical approaches
  • Pragmatic and efficient practices - cost effective compliance

This course was developed by members of the ISPE GAMP Community of Practice. GAMP was established by industry leaders to interpret and improve the understanding of regulations governing the use of computerized systems in pharmaceutical manufacturing.


Resources and Activities

GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition

Course Modules

  • Introduction
  • Regulations and Regulators
  • Requirements of 21 CFR Part 11
  • Overview of GAMP® 5
  • GAMP® 5 Lifecycle in Detail
  • Regulated Company and Supplier Activities
  • Quality Risk Management and Detailed Risk
  • Testing
  • Operational Phases
  • Effective and Efficient Compliance

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 scaleable and efficient system lifecycle, Quality Risk Management applying ICH Q9, updated GAMP categories, supplier assessment, and the selection of appropriate specification and verification activities.

Learning Objectives:

  • Explain the regulatory requirements and expectations for computerized systems used in pharmaceutical manufacturing
  • Apply GAMP principles to specific systems and cases
  • Describe the GAMP approach to computerized system compliance
  • Apply these ideas to systems within your own organization

Community of Practice (COP)

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


Daily Schedule and Pricing

  • online-live
    Online Live
    2 - 3 Nov 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 - 1300 Lunch
    1300 - 1430 Course Content & Exercise
    1430 - 1445 Break
    1445 - 1615 Course Content & Exercise
    1615 - 1630 Wrap-up, Questions, Discussion 
    0830 – 0845 Login
    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, Discussion 

    Featured Instructors

    Registration Fee

    REGULAR
    Member € 1,785.00
    Nonmember   € 2,085.00
    Government / Academia / Emerging Economies* € 550.00
    Student* € 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.