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

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

Date

Location

Country

Instructor(s)

19 - 21 May 2014 Brussels Belgium Mr. Sion Wyn
19 - 21 May 2014 Indianapolis, IN USA Ms. Kate Townsend
9 - 11 Jun 2014 Atlanta, GA USA Mr. James W. John

Description

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 , updated 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
  • 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
  • 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

Course Modules

  • Regulatory Requirements
  • Overview of GAMP® 5
  • Lifestyle in Detail
  • User and Supplier Roles
  • Quality Risk Management and Detailed Risk
  • Testing
  • Operational Phases
  • Effective and Efficient Compliance
  • Part 11 Background
  • Part 11 Final Guidance
  • European Requirement
  • Part 11 Inspection Assignments
  • Part 11 Requirements
  • Annex 11
  • Risk Management Approach to Compliant Electronic Records

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
  • 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
  • Testing in GAMP-Principles and practical approaches
  • 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
  • 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).

Continuing Education Units 

ISPE will provide continuing education units (ISPE CEUs) for all North American and European courses.  CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.  Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials.  Statements of credit will be available for download in your ISPE account within four weeks of the completion of training.  Instruction for download will be sent when the CEUs are available.  One hour of education programming equals 0.1 ISPE CEU credits.

Last Update: 21 February 2014

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