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

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?
• How do investigators approach a computer systems inspection?
• 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 and Part 11 "add on" inspections
• A Risk-based approach to Electronic Records and Signatures to meet both FDA and EU expectations

Course Modules

• Regulatory Requirements
• Overview of GAMP^® 5
• User and Supplier Roles
• Quality Risk Management and Detailed Risk
• Testing
• Operational Phases
• Efficiency Improvements
• Part 11 Background
• Part 11 Final Guidance
• Part 11 Inspection Assignments
• Part 11 Requirements
• Annex 11

Take Back to Your Job:

• Understand the FDA and EU Regulatory requirements for GxP Computerized systems
• How investigators approach a computer systems inspection
• 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 and Part 11 “add on” inspections
• 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).

CPIP™ Technical Knowledge and Competency Elements

This course contains knowledge related to the CPIP™ technical knowledge competency element: Information 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.

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