GAMP® 5 Training - Fundamentals of GAMP® 5 Guidance

The GAMP® 5 Training Course can be delivered in a hotel, one of our offices, your premises or online via a virtual classroom. The course content can be tailored to meet your requirements. Request a quote for an onsite or online virtual course for an agreed number of delegates from your site.

Keeping current with the latest regulatory requirements and industry guidance can be a challenge when you have a hundred and one tasks to complete, but you can achieve it by taking just one day out of your working schedule to attend this catch-up course.

It will help unravel the main topics in the latest version of GAMP® 5: A Risk-Based Approach to Compliant GxP Computerised Systems, and help refresh existing knowledge and practice.

The GAMP® 5 course is ideal for those working in healthcare manufacturing and related IT departments, as well as suppliers.  People employed in the National Blood Service and other industries such as bank ATM manufacturers, have also attended and benefited from this course.

• Identify how GAMP® guidance was developed and the reasons behind it
• Regulatory requirements
• Technological innovation
• Interpretation of rules and regulations
• Review the Life Cycle approach and phases, including: Life cycle concepts; concept, project and retirement
• Practical examples based upon GAMP® categories of software
• Operational phases including:
• Handover
• CAPA
• Change management
• Security 
• System administration
• Latest terminology and common themes including, the relationship between qualification terminology and GAMP® 5 activities
• V model approach for IT systems and process control systems
• Categories of software, hardware and the validation approach
• Introducing Quality Risk Management
• An overview of Quality Risk Management
• Description of the risk assessment process including sample risk assessments
• Develop understanding of guidance for supplier activities
• Consider help for suppliers
• Describe regulated company activities to assure computerised system compliance
• Elements to achieve compliance
• Regulatory approach to audits and non-compliance
• Areas particularly vulnerable to non-compliance for manufacturers, and supplier considerations
• Review other GAMP® 5 guidance articles and appendices including:
• Guidance on efficiency improvements 
• Appendices: 
• Management
• Development
• Operation
• Special Interest Topics
• Other General Appendices

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 or as an online virtual classroom course for an agreed number of delegates from your site. Request a quote.

“Clear and concise. Very good at delivering the ‘message’.”
Stirling Medical

“Covered all aspects of GAMP® 5 and focussed on areas such as risk management that we currently need direction on.”
GlaxoSmithKline

“Knowledgeable trainer. Good overview provided.”
GlaxoSmithKline

“Enjoyed the course, thought provoking as well.”
Stirling Medical

“This was a good lead in to the subject.  For the uninitiated the structure of the course was well laid out, going from basic introduction on to active workshops which put the new knowledge into perspective.”
Domino UK Ltd.

“Excellent course.”
Domino UK Ltd.

“Much clearer understanding after the course.”
Open course delegate

“Certainly included subjects which were very pertinent to our business. Very well planned.”
Open course delegate

“Very well presented.”
Open course delegate

"Very useful, especially information on change control management and risk assessment."
Open course delegate

"Well covered, depth just about right."
Open course delegate

"Excellent course."
Open course delegate

"It gave me the level of understanding I was expecting."
Open course delegate

"Relaxed and good learning environment."
Open course delegate

"A very dry subject handled well by an obviously experienced trainer."
Genzyme

"Very informative."
Boulting Group

"Very informative and shall allow us to follow with more understanding in the future."
Bespak Europe Ltd

"Trainer was very nice and tried to adapt himself to the team who had been challenging through the questions they asked."
Bespak Europe Ltd

"Well presented and informative in a friendly manner."
Open course delegate

“Overall – Very happy.”
Samarind Limited

“Very informative.”
Solidsoft Reply 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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