INTRODUCTION
The GAMP® (Good Automated Manufacturing Practice) 5 guide and the GAMP® Guide: Risk-Based Approach to Electronic Records and Signatures. provide detail on the guidelines and the techniques involved in achieving auditable system compliance through a structured validation process.
BSM offers a wide range of cost effective modular computer compliance and validation training courses to suit any audience. The series of modular training courses has been compiled based on the latest industry guidance and best practice. All courses are interactive and where appropriate use real examples of the application of the ISPE GAMP® 5 validation principles. The modular nature of these courses enables you to create and build a series of courses to meet your specific requirements. This could range from a one day overview course to a more detailed two, three, four or five day course designed for your target audience.
WHO SHOULD ATTEND
QA/IS management and people unfamiliar with the techniques and objectives of GAMP® 5.
WORKSHOP OBJECTIVES
The workshop provides a comprehensive overview of the key points of the GAMP® guides - backed up by interactive exercises and multiple choice questions to ensure that attendees will retain most of the content covered.
WORKSHOP AGENDA
GAMP® 5 Training - 1 Day Course
Morning Session
- Introduction to Validation
- Introduction to GAMP®
- Why do we need GAMP®
- GAMP® History
- Purpose of GAMP®
- Scope of GAMP®
- Benefits of GAMP®
- Structure of GAMP®
Afternoon Session
- GAMP® Principles and Tools
- Validation Planning
- Validation Life Cycle
- Validation Reporting
- Supplier Audits
- Software Categorisation
- Risk Management
- Periodic Review
- Traceability
- Business Continuity Planning
- Assessment and Certificates.
Training materials and an assessment/certificate are also provided.
FURTHER INFORMATION
For further information on running this workshop in-house, please e-mail Frank Crewe at frank.crewe@bsm.ie
ISPE owns the GAMP® trademark http://www.ispe.org/
Linda Davey will respond to your query.