Are you trying to interpret and understand more precisely what validation means? If you read regulatory requirements regarding European, American or other countries, does it still leave you puzzled?

It could be that you’re new to the company or role. You could work for a supplier and want to learn and appreciate what validation means for you and your customers.

The Understanding Validation (1 Day) Training is a foundation-based course which will help increase your understanding of what validation means to the healthcare manufacturing industry.

When you have completed the course, you will have an appreciation of the different terms and application of validation for pharmaceutical and medical device manufacturers. You’ll also understand how regulatory requirements affect companies, and be able to identify validation activities where mistakes, and their subsequent consequences, can occur.

• Investigate the history and requirements for validation
  • What is validation?
  • Regulatory requirements and expectations
• Understand the terms and the application of validation
  • Discuss the terms used
  • Evaluate the key stages of validation
  • Use the basic 'V' model for a simple approach
  • View a CD video and answer questions
  • How far does Good Engineering Practice go towards meeting compliance?
• Use case studies to explore the causes and implications of non compliant validation
  • Analyse real scenarios
  • Determine suitable actions for workplace improvements

“Excellent material provided.”
Unipath

“I am very pleased with what I learned from this course.”
Gilead Sciences Ltd

“This was a refreshing change, I thought it would be very technical but in fact the day was not!”
Schneider Electric

“Would definitely recommend course to management for use by other staff.”
Seal Sands Chemicals

“Good course.”
ConvaTec Ltd

“Good re-cap plus some new information regarding PLCs was useful.”
Teva Runcorn

“The course pulled together the whole validation process in a simple and clear manner.”
Open course delegate

“The course gave a useful overview of validation and helped put certain elements into a clearer context.”
Open course delegate

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 ›