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

GAMP® Training

Good Automated Manufacturing Practice® (GAMP®) was developed to assist manufacturing and supplier organisations develop, operate and manage automated equipment and computer systems and applications, whilst meeting regulatory requirements and creating products fit for purpose.

Strict GMP regulatory standards must be met in producing quality medical devices, and human and veterinary medicines, as well as during research and development stages, through clinical trials and subsequent market authorisation. In the handling of blood for transfusions, there are legal requirements in place to ensure that the patient is always protected, by ensuring product quality.

Industrial Technology Systems Ltd (ITS) has extensive experience in GAMP® training, and has responded to the publication of the new GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems, by designing three new courses, suitable for every learner from those familiar with GAMP® to those coming fresh to the guidelines.

  • GAMP® 5 Training - Fundamentals of GAMP® 5 Guidance is an introductory one-day course suitable for those with little or no knowledge of GAMP® 5, covering the basics of how GAMP® evolved, details of regulatory requirements and expectations, and the new guidelines and approaches.
  • GAMP® 5 (3 Day) Training course provides an introduction into GAMP®, its application and use for organisations, including relative regulatory expectations, and an in-depth exploration of the new guidelines and approaches.
  • IT Infrastructure Control and Compliance Training course provides an understanding of essential elements of an IT infrastructure including requirements for qualification and implementing good management practices for maintaining effective compliance in a regulated healthcare company.
  • GxP Compliant Laboratory Computerised Systems Training Course provides an understanding for implementing a rational, flexible approach to achieve greater efficiency and productivity aligned with focus on data integrity, product quality and patient safety.

Testimonials

GAMP® (3 Day) Course

“Excellent and well adapted course.”
Cobra Biomanufacturing

“Good overview and background. Gave an understanding of why AstraZeneca do certain things.”
AstraZeneca

“I found the course highly informative, well structured and very functional. The instructor was very helpful and allowed time to answer specific questions without deviating from course content.”
Encap Drug Delivery

“Course offered valuable information and was an excellent introduction to GAMP® 4. Not only were the main learning objectives covered, but the presenter went further to tailor the course to meet the attendees’ requirements.”
Ranier Technology Ltd.

“Informative and interesting 3 days.”
ConvaTec

“Course highly detailed.”
ConvaTec

“I found this course highly informative, well structured and very functional. The instructor was very helpful and allowed time to answer specific questions without deviating from the course content.”
Open course delegate

“Course offered available information and was an excellent introduction to GAMP® 4. Not only were the learning objectives covered, but the presenter went further to tailor the course to meet the attendees’ requirements.”
Open course delegate

GAMP® (1 Day) Course

“Clear & concise. Very good at delivering the ‘message’.”
Stirling Medical

“Enjoyed the course, thought provoking as well.”
Stirling Medical

“This was a good lead in to the subject.  For the uninitiated the structure of the course was well laid out, going from basic introduction on to active workshops which put the new knowledge into perspective.”
Domino UK Ltd.

“Excellent course.”
Domino UK Ltd.

“Outline of GAMP was excellent, and the course achieved its objectives.”
Tetra Pak.

“Very interesting introduction to GAMP® 4. Trainer adapted well to meet our customer needs.”
Open course delegate

“Much clearer understanding after the course.”
Open course delegate

“Certainly included subjects which were very pertinent to our business. Very well planned.”
Open course delegate

“Very well presented.”
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