Online Good Manufacturing Practice (GMP) Training

Aimed at organisations, new starters and existing staff as part of their ongoing GMP training. The course provides a detailed overview of why we have GMP and what GMP is in three CORE chapters with additional chapters covering specific GMP requirements for different parts of the site.

Details of the versions currently available are detailed below:

• GMP for Manufacturing personnel - around 60 minutes costing £95
• GMP for Packaging personnel - around 60 minutes costing £95
• GMP for Warehouse personnel - around 60 minutes costing £95
• GMP for Laboratory personnel - around 60 minutes costing £95

GMP Online Course Contents:
The course consists of the following chapters.  Typically delegates do all three CORE chapters and any ADDITIONAL chapters that are relevant to their role.  For example, a person working in the Packaging department will undertake Chapters 1 to 3 and Chapter 6.

GMP Online Course Core Chapters:
Relevant for everyone:

Chapter 1: An introduction to the pharmaceutical industry
This chapter provides an overview of the pharmaceutical industry and the need to regulate medicine manufacture and supply.

Chapter 2: An introduction to Good Manufacturing  Practice
This chapter introduces the concept of Manufacturing Authorisations for sites and Marketing Authorisations for medicines and the need for Good Manufacturing Practice at sites making pharmaceuticals.

Chapter 3: The Good Manufacturing Practice guidelines
The main contents and requirements of the 9 chapters of European Union GMP (EU GMP) are explained and why these are important.  Reference is also made to the additional requirements in the Annexes of EU GMP.
The CORE chapters (above) are available either as a UK or non-UK version.  The UK version has references to the UK’s Regulatory Authority (the MHRA) and their “Orange Guide”, whereas the non-UK version does not.

ADDITIONAL GMP Online Course chapters:
These are specific for different parts of the site, and typically a delegate will also take one of these, depending on which area they work in.

Chapter 4: GMP in the Warehouse
This chapter covers the key GMP requirements for the warehouse and is designed for people working in good-in or despatch.

Chapter 5: GMP in Manufacturing
This chapter covers the key GMP requirements for manufacturing and is designed for people working in manufacturing areas.

Chapter 6:  GMP in Packaging
This chapter covers the key GMP requirements for packaging and is designed for people working in packaging.

Chapter 7: GMP in the Laboratory
This chapter covers the key GMP requirements for the Quality Control laboratory and is designed for people working in the laboratory.

Duration:
The duration of each chapter lasts approximately 10 – 15 minutes.  The standard 4 chapter course should last about an hour.

Assessment and certificates:
Each chapter has a series of randomly selected assessment quiz questions at the end of each one.  An 80% pass mark is expected.  Guidance is provided if a delegate gets an answer wrong.  After successful completion of the course a certificate is available for download by the delegate.

Prices:
Individuals:
The individual price for access to the three CORE chapters and one ADDITIONAL chapter is £95.
Extra additional chapters are charged at £25 each.  See below for prices.

Special Versions:
GMP core plus two chapters
Takes around 75 minutes - charged at £120.00

GMP core plus three chapters
Takes around 90 minutes - charged at £145.00

GMP all chapters
Takes around 115 minutes - charged at £170.00

Delegates will have access to the course for a 2 month period from the registration of the delegate.  If they do not complete the course within this time then they will need to pay again to complete the course.  No certificate is issued if the course is not completed in full.

Group Discount:
Discounts are available for groups of 10 or above and the discount increases depending on numbers.  Please  contact us for further information.

Purchase of materials outright:
If you are interested in purchasing the course materials for use on your own Learning Management Systems (LMS) then please contact us to discuss options.

Sales Tax:
Price excludes UK Value Added Tax (VAT) at 20% which will also be charged for UK based delegates.  VAT will not be charged for delegates from outside of the European Union (EU) or for delegates from within the EU if they supply their company’s VAT number when booking.