Understanding GMP Change Control Training for Engineering and IT

The Understanding GMP Change Control Training for Engineering and IT Course can be delivered in a hotel, one of our offices, or your premises. The course content can be tailored to meet your requirements.

To build an understanding of what Change Control means for pharmaceutical and medical device manufacturers, and their regulators.

• Investigate why Change Management is a key tool to aid GMP/GxP compliance for pharmaceutical, medical device manufacturers and their suppliers
• Discuss and explain how and why Change Control is a vital part of GMP for healthcare manufacturers
• Investigate the consequences of non-compliance with GMP for patients through inadequate application of the Change Control process
• Look at how healthcare manufacturers can experience regulatory action through non-compliance with Change Control procedures
• Review common weaknesses regarding equipment and computer systems in Change Control though case study, GAMP® 5 references and audit outcomes
• Review example overall Change Management SOP
• Determine the SOP process
• Review documentary requirements
• Explore what Change Management and Configuration Management means for Engineering and IT
• Examine example SOP for determining what constitutes a Change Control requirement through Project Change Control and Operational Change Control
• Explore utilising risk management activities as a part of the Change Control process
• Review Change and Configuration Management relative to software and hardware as per GAMP® 5

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.

"Overall very enjoyable, informative and useful. Good level of participation."
Laleham Healthcare Ltd

"A good base/start point for the engineering and QA team to implement on a regular basis."
Laleham Healthcare Ltd

"Very informative and presented well."
Laleham Healthcare Ltd

ITS’ Regulatory Training Manager, Alan Benbow, has developed extensive knowledge of this specialist area from 22 years’ industry experience working with Johnson & Johnson, and Wyeth Pharmaceuticals.

During his 14 years at Wyeth, Alan was involved in a wide range of activities including, at operational levels, developing operators, craftsmen, and technicians; he was also responsible for training and assessing operational employees to NVQ standards. From a mid-management perspective, training and development initiatives included facilitating continuous improvement projects and best practices, and receiving internal recognition awards. more ›