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Validation Training


  • Understanding Validation Training

    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.


  • Interpreting 21 CFR Part 11, Revised EU Annex 11 and Data Integrity Training

    The American regulation 21 CFR Part 11: Electronic Records; Electronic Signatures has been one of the most significantly difficult regulations for healthcare manufacturers to understand and implement since its conception and authorisation in 1997.  The Interpreting the Regulation 21 CFR Part 11 and revised EU Annex 11 (1 Day) Training Course, seeks to demystify misconceptions and beliefs on what it means for companies.

    The course also provides a review and comparison of Part 11 with Annex 11 and related EU GMP Volume 4 Chapter 4 on Documentation.

    Regulated life science companies rely on the integrity of their data to ensure product quality. With increasing use of computerised systems in GMP operations regulatory authorities need to be assured that companies can manage the challenges that face them in understanding the complexities surrounding this subject and be confident that implemented strategies are effective.

    So if you want to understand 21 CFR Part 11, what has been revised in the EU GMP Annex 11 and Chapter 4, and examine the GAMP®’s interpretation of the guidance, and the subject of data integrity then why not attend our course?


  • Understanding Validation, GAMP® 5, 21 CFR Part 11 and Data Integrity Training Programme

    The purpose of the Understanding Validation, GAMP® 5, 21 CFR Part 11 and Data Integrity (3 Day) Training Programme is to provide learners with the opportunity of either taking one course alone, a mix of the following courses or all three in their entirety, over consecutive days.

    The complete programme allows learners to build a basic knowledge of validation through to the latest GAMP® 5 guidance, and then on to specific American regulatory requirements for 21 CFR Part 11 Electronic Records; Electronic Signatures.

    The programme comprises Understanding Validation Training (Day 1), GAMP® 5 Training - Fundamentals of GAMP® 5 Guidance Training (Day 2), and Interpreting 21 CFR Part 11 and Revised EU Annex 11 and Data Integrity Training (Day 3).


  • Understanding Validation Training (2 Day)

    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.