Validation Training
Validation in regulated industries is vital in ensuring that premises, equipment, computer systems and processes used as part of manufacturing processes, are fit for their purpose.
The Medicines and Healthcare products Regulatory Agency (MHRA) Rules and Guidance for Pharmaceutical Manufacturers and Distributors (The Orange Guide), states that “Validation should reinforce GMP … in accordance with defined procedures.” The same applies to other areas of governance, including the FDA, the Medical Devices Directive and the Veterinary Medicines Directive.
Industrial Technology Systems Ltd (ITS) offers the following courses to help user organisations, suppliers and companies of any size, understand validation requirements:
- Understanding Validation Training is a one-day course which provides an introduction to validation, how it has developed, the regulatory viewpoint and what can go wrong with validation.
- Understanding the Regulation 21 CFR Part 11 Training is a one-day course providing an introductory insight into the USA’s regulation for Electronic Records and Signatures. It includes the associated validation requirements, comparison with the EU’s Annex 11 and GAMP®’s associated best practice recommendations.
- Validation and Compliance Training Programme is a three-day course comprising Understanding Validation on day one, GAMP® on day two and Understanding the Regulation 21 CFR Part 11 on day three.
Testimonials:
Understanding Validation Training
“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
“The course pulled together the whole validation process in a simple but 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
Validation & Compliance Training Programme
“Found the general overview very useful and the last session going through the V model – excellent.”
Open course delegates
“Trainer was very good at adapting course content to reflect the unique nature of our industry.”
Open course delegates
ISPE owns the GAMP® trademark http://www.ispe.org/
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