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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

You may be interested in attending the:

Great Lakes GAMP Americas Forum, 15 June 2017
Member $100 - Non-Member $125
Indianapolis, Indiana – Get the details here!


This 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 scaleable 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 lifecycle 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

Water 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).

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This course is not currently scheduled, but may be offered at your company site.

Please contact ISPE for more information.

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