Understanding Validation Training (2 Day)

The 2-Day 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 what validation means? If you read regulatory requirements, either European, American or other countries, does it still leave you puzzled?

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

The first day of the Understanding Validation Training Course, provides an introduction to help you understand what validation means to the healthcare manufacturing industry. The second day provides an oversight of engineering project activities, deliverables, and documentation. A further explanation is given on how risk management can be utilised throughout the equipment/system life-cycle.

Previous course participants have included people from pharmaceutical and medical device manufacturers and also suppliers to the industry.

• Understand the history and importance of 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
• Identify, appreciate and apply risk assessment relative to validation/life-cycle activities
• Establish how engineers’ practices can have significant implications on successful equipment validation projects
• Recognition of the deliverables in the Validation Plan and final Validation Report detailing compliance to the Validation Plan, through relevance to URS, DQ, IQ, OQ, PQ , process validation activities and the importance of engineering input through these stages
• Factory Acceptance Testing and documentation practices, including identifying potential hazards
• Use of test witnesses, best practice testing and documentation requirements, including evidence for verification during qualification
• Understand the importance of Project Change Control and Operational Change Control through the equipment life cycle, to ensure ongoing product quality
• Reflect on overall verification and validation activities for equipment
• End of course evaluation test and feedback

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.

"Well structured course, which was modified by trainer to suit student needs / requests."
Open course delegate

"Enjoyable, easy going atmosphere."
Open course delegate

“Very useful to my daily work demands.”
Open course delegate

“Very informative course and beneficial.”
Open course delegate

“Thoroughly enjoyed this course and I believe I have learned a lot over the 2 days.”
Open course delegate

“Very well structured and delivered.”
Open course delegate

“Very good and tailored to our needs.”
Open course delegate

“Well presented, made a complex subject understandable.”
Open course delegate

“It was good that the course could be tailored to be relevant to our processes and needs.”
Open course delegate

“Very relevant course content. The course has been very useful to me in my role and I can take back helpful information to my department. Course length was good - plenty of time for discussion.”
East of Scotland Blood Transfusion Service

“As an introduction to validation, the course was thorough, comprehensive and enjoyable.”
East of Scotland Blood Transfusion Service

“Tailored to our requirements - flexible approach. Trainer had good rapport with trainees. Ample opportunity for discussion."
East of Scotland Blood Transfusion Service

“Additional material was provided above and beyond the original course content to aid my specific requirements."
Reckitt Benckiser

“A very structured training course that was delivered in a manner that someone not from a quality background could understand." 
Firstan Ltd

“Thank you for bespoking this package for our industry." 
Firstan Ltd

“Good course and met my objectives." 
Firstan Ltd

“Excellent. The information and understanding became easier as it developed." 
Firstan Ltd

"Validation is not something I am involved with daily but the course has enabled me to complete the project I was struggling with." 
DHL

“Course well-structured and delivered in an easy to understand format.”
Selo UK Ltd

“Invaluable tool for suppliers into the pharma industry.”
Anritsu Industrial Solutions

“Trainer is good – very knowledgeable.”
Vascutek Ltd

“Was very informative.”
Vascutek Ltd

“Very helpful and easy to understand.”
Vascutek Ltd

“Great course and great knowledge.”
Olympus Surgical Technologies Europe

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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