Basic Principles of Computerized Systems Compliance: Applying the GAMP5® Guide: A Risk-based Approach to Compliant GxP Computerized Systems (T07)

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Training

Level: Fundamental
ISPE CEUs: 1.3
Type: Classroom Training Course

Date	Location	Country	Instructor(s)
This course is not currently scheduled, but may be conducted at your company. Please contact ISPE for more information.

Description

This 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.

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.

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

Course topics include:

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.

Course Modules

Regulatory Requirements
Overview of GAMP 5
User and Supplier Roles
Quality Risk Management and Detailed Risk
Testing
Operational Phases
Efficiency Improvements

Take Back to Your Job

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

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 ISPE GAMP Community of Practice (COP).

CPIP™ Technical Knowledge and Competency Elements

This course contains knowledge related to the CPIP™ technical knowledge competency elements Facilities and Equipment and Production Systems. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.

Continuing Education Units

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.

Last Update: 08 January 2013