Understanding Validation Training

The Understanding Validation 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.

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

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.

“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

“Excellent course. Covered everything and lots more than I was expecting it to.  Learnt a lot and it will certainly help me in my future role.”
Open course delegate

“Very good introduction to concepts.”
Open course delegate

“Trainer was knowledgeable and course content met my needs.”
Life Technologies Limited

“I would recommend.”
Life Technologies Limited

“Well executed.”
Life Technologies Limited

“Good and very informative.”
Life Technologies Limited

“Topics explained clearly.”
Life Technologies Limited

ITS’ Regulatory Compliance Trainer, Dr Jennifer Thompson, has over 20 years of experience in the pharmaceutical sector in computer systems validation and IT infrastructure controls and compliance and has delivered projects for a wide range of companies in the UK, EU and USA including GlaxoSmithKline, Novartis Healthcare, Lonza Biologics, Elan Pharmaceuticals, Hoffman LaRoche and others. Her experience covers computerised systems used in manufacturing, laboratories, enterprise systems and clinical trials management. She has written articles and given presentations on a wide range of topics and contributed to the GAMP® Good Practice Guide “A Risk-based Approach to GxP Process Control Systems” and “The Risk Based Compliance Handbook” by Siegfried Schmitt (Paraxel).

more...