Regulatory Compliance Training > GMP, GAMP® & Validation Training  Validation Training

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 Validation (2 Day) Training builds and develops an understanding of validation for equipment, processes and automated systems, by highlighting risk assessment, the importance of Project Change Control and Operational Change Control, and reflecting on overall verification and validation activities for equipment.
  • 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 and understanding Data Integrity.
  • Understanding Validation, GAMP® 5, 21 CFR Part 11 and Data Integrity 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

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

“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 delegate

“Trainer was very good at adapting course content to reflect the unique nature of our industry.”
Open course delegate

“Gave a good, clear understanding of a V model.”
Open course delegate

“Alan was quite happy to adapt his plans to suit the needs of attendees rather than sticking to a script.”
Open course delegate

“Very well run course. I got a lot out of it. Good venue and food a bonus.”
Open course delegate

ISPE owns the GAMP® trademark http://www.ispe.org/



Contact our team today

For further information, please contact
our team on +44 (0)1642 222232 or
email enquiries@its-ltd.co.uk