GAMP® 5 (3 Day) Training

The GAMP® 5 (3 Day) Training Course can be delivered in a hotel, one of our offices, or your premises. The course content can be tailored to meet your requirements. Request a quote for an onsite course.

Keeping current with the latest regulatory requirements and industry guidance can be a challenge when you have a hundred and one tasks to complete.

The GAMP® 5 (3 Day) Training goes beyond our Fundamentals of GAMP® 5 Guidance by investigating in depth the main topics in the latest version of GAMP® 5: A Risk-Based Approach to Compliant GxP Computerised Systems, and reviewing sample appendices from the following sections: Development, Management, Operation and Special Interest Topics.

Taking the opportunity to attend this course is useful for people working in healthcare manufacturing and related IT departments. Suppliers can also benefit. National Blood Service employees and other industries such as bank ATM manufacturers have also attended this course.

So if you want a full working understanding of current regulatory thinking on computerised systems in industry, for IT, process control systems and manufacturing/packaging equipment, why not attend our course?

Day 1

• Investigate the reasons for the GAMP® 5 version update
• Industry developments
• Regulatory drive including Quality Risk Management, ICH Guidance and integration into QMS
• Latest terminology and common themes including relationship between Qualification Terminology and GAMP® 5 activities
• Compare the differences between GAMP® 4 and GAMP® 5
• Cross referenced table of differences
• Look at key concepts
• Main article and contents
• Appendices
• Review the life cycle approach and phases, including: life cycle concepts; concept, project and retirement
• Project
• planning
• specification
• configuration and coding
• verification
• reporting and release
• support
• To include practical examples based upon GAMP® categories of software
• Operational phases including
  • Handover
  • CAPA
  • Change management
  • Security and system administration
• Introducing Quality Risk Management
• An overview of Quality Risk Management including:
• Integration to the QMS
• The process itself and links to ICH Q9
• Describe regulated company activities to assure computerised system compliance
• Elements to achieve compliance
• Policies and procedures, roles and responsibilities
• Training, managing supplier relationships, system inventories and specific activities
• Develop understanding of guidance on supplier activities
• View help for suppliers; non configured product, configured product and custom package
• Investigate supplier best practices

Day 2

• Consider guidance on efficiency improvements
• Specific points in determining objective user requirements
• Utilise risk assessment practice to determine life cycle activities
• Influence supplier input and maximise use of own documentation
• Effective testing and system handover
• Operational activities
• Review main article topic 4, Life Cycle Phases, related Management Appendices
  • M1 Validation Planning
  • M2 Supplier Assessment
  • M4 Categories of Software and Hardware
  • M5 Design Review and Traceability
  • M7 Validation Reporting
  • Investigate changes to appendices and also new management appendix M10
• View appendix M3 Science Based Quality Risk Management relative to article 4 and 5 in the main contents of the guide
• Roles and responsibilities
• Guidance and examples for different categories of systems

Day 3

• Research remaining appendices
• D2 Functional Specification
• D3 Configuration and Design
• D4 Incident Management
• D5 Testing relative to article 4
• Check revised appendices and new appendices
• D6 System Description
• D7 Data Migration
• Develop understanding of new Operational Appendices covering
• O1 Handover
• O4 Incident Management
• O5 CAPA
• O7 Repair Activity
• O12 System Administration
• Investigate the special interest topics appendices
• S1 Alignment of ASTM E2500
• S2 Electronic Production Records
• S3 End User Applications
• S4 Patch Management
• S5 Managing Quality within an outsourced IS/IT environment
• S6 Organisational Change
• Review of G1 GAMP® Good Practice Guides

ISPE owns the GAMP® trademark http://www.ispe.org/

This course can be delivered to a group of up to 12 delegates at your premises. Request a quote for an onsite course.

ITS offers onsite training courses delivered by an English-only speaking trainer for companies in Europe and Worldwide. ITS has delivered courses to delegates from a number of countries including Belgium, France, Germany, Ireland, Jordan, Russia, Sweden and Switzerland.

“An excellent overview of the GAMP® guide and its structure and content.”
GlaxoSmithKline

“Very enjoyable and informative.“
The Co-Operative Pharmacy

“Easy to follow with clear notes provided.”
Bio Products Laboratory Ltd

“Very good training. Enjoyed the small setting which allowed for lots of questions.”
London School of Hygiene & Tropical Medicine

“I found the course to be thoroughly interesting. I learnt a great deal and the trainer, Alan was very knowledgeable. I would definitely recommend this course.”
Cooper Vision

“Excellent course. It was very informative and easy to apply to my current role.”
Sanofi-aventis

“It was very informative, well explained and applied to practical examples.”
DePuy

“Very good course, well presented with mix of media and experienced trainer. Good extra resources recommended.”
DePuy

“Very good knowledge trainer.”
GlaxoSmithKline

“The course has been tailored to my specific needs. I can now progress to the next update of the company validation approach.”
Open course delegate

“Clear and in-depth.”
Jenson R+

“Very useful.”
Jenson R+

“Good overview of GAMP® 5.”
Bioquell UK Ltd

“Well structured and delivered in easy to understand terms.”
Anritsu Industrial Solutions

“Worthwhile to attend.”
ABB Ltd

“Comprehensive and informative”
Selo UK Ltd

“I’m very satisfied with the course. Thank you! Along with the amazing venue, I really got all I needed from this.”
Orion Oyj

“Very helpful.”
ELPRO-BUCHS AG

“The trainer supplied was experienced and knowledgeable in the subject.”
Pall Europe Limited

“In-depth handouts and flexible training.”
Pall Europe Limited

“Good course pace and learning materials.”
Pall Europe Limited

“Detailed and friendly.”
Novartis Grimsby Ltd

“Very informative.”
Novartis Grimsby Ltd

ITS’ Regulatory Compliance Services’ Manager, Elizabeth Vaughan, has developed extensive knowledge of this specialist area from over 30 years’ industry experience working with Sanofi, Bristol Myers Squibb, Diomed Developments and Vifor Pharma UK. Elizabeth has worked in quality roles within the laboratory and pharmaceutical industry, and gained extensive experience in global quality systems and regulatory affairs, as well as ISO 13485, ISO 9001 and cGMP compliance. Throughout her career, she has been responsible for sharing her knowledge through the design and delivery of a range of training courses for production personnel including Good Manufacturing Practice, Change Control, Deviation Management, Electronic Record Compliance, Validation and Management of API Suppliers/Manufacturers. Elizabeth also has extensive experience in providing quality and GMP training to improve the performance of site quality managers.

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