Applying GMP Change Control and Risk Assessment for Equipment and IT Applications

The Applying GMP Change Control and Risk Assessment for Equipment and IT ApplicationsTraining 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 and related risk assessment means for pharmaceutical, 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
• Review of Change and Configuration Management relative to software and hardware as per GAMP® 5
• Consider applying risk management methods including FMEA and the GAMP® approach as part of the Change Control process
  • Summarise the different approaches to Risk Assessment methods and focus of use giving examples of FMEA and the GAMP® approach
• Apply Risk Assessment methods as a part of Change Control to case study scenarios, exploring:-
  • URS development stage
  • Supplier assessment capability
  • Determining GAMP® categories of software for process control and other systems
  • Scaling qualification activities based upon FAT activities/results
  • Using as part of Change Control activity for scaling verification activities

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.

"The course itself was very useful in Risk Assessments, like for like Change Control & was tutored to areas which I am involved in in my current job role."
British American Tobacco

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 ›