The Introducing GMP Training Course is a foundation or refresher course useful for individuals who need to understand what Good Manufacturing Practice (GMP) means for healthcare manufacturers, and subsequently their suppliers.

The course takes into consideration how GMP is applied throughout companies, by viewing the organisation using the categories: People, Procedures and Documentation, Products and Components, and Production Areas and Equipment.

Other key parts of the course include a review of the industry regulators, their requirements and how they regulate. Also investigated are the consequences of non-compliance, and people behaviours and habits, to encourage GMP in operations.

The course attracts a mix of learners from different industries and mixed disciplines, including pharmaceutical and medical device manufacturers, wholesale distributors, and suppliers including OEMs.

• Understand the need for GMP
  • What is GMP?
  • GMP and its link with Quality Assurance and Quality Control
• Define the GMP guidelines and how agencies enforce them
  • What are the relevant regulations?
  • How the main regulatory agencies audit and enforce them
• Investigate the 4 Ps
  • People - adequacy, experience, training and the role of the Qualified / Responsible Person
  • Procedures and Documentation - from the completion of SOPs to in-process controls
  • Production Areas and Equipment - premises, layouts and considerations
  • Products and Components - incoming, handling, storage, packaging, labelling and non-conforming products
  • Identify potential GMP violations and their consequences
  • Use interactive case studies to analyse scenarios
  • Examine real reported incidents
• Determine behaviours that improve GMP
• Plan for workplace improvements

“Very informative and useful information that will go towards making some improvements within our non-GMP facility.”
Sigma Genosys Ltd

"I enjoyed this course very much and will take on board what I have learned. A very professional teacher.”
TSL

"Excellent. Very interesting and a variety of media used.”
TSL

"Excellent training course - throughly enjoyable.”
TSL

“Enjoyed the course.  It raised awareness across other departments.”
TSL

“It was an excellent course, which I can highly recommend for all supervisors using GMP.” 
Open course delegate

“Alan’s style was excellent. It was the right mix of theory and interactive.  A very enjoyable course.”
Open course delegate

“The trainer was quick to recognise our needs."
DSTL

ITS’ Regulatory Training Manager, Alan Benbow, has developed extensive knowledge of this specialist area from 22 years’ industry experience working with Johnson & Johnson, and Wyeth Pharmaceuticals.

During his 14 years at Wyeth, Alan was involved in a wide range of activities including, at operational levels, developing operators, craftsmen, and technicians; he was also responsible for training and assessing operational employees to NVQ standards. From a mid-management perspective, training and development initiatives included facilitating continuous improvement projects and best practices, and receiving internal recognition awards. more ›