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Introduction to cGMP for the (Bio) Pharmaceutical Industry

The aim of this course is to provide learners with fundamental knowledge related to the requirements of working in a cGMP (Good Manufacturing Practice), regulated (bio)pharmaceutical manufacturing environment. On completion of the programme learners will be able to demonstrate core knowledge of quality systems, industry regulatory requirements, validation, documentation, and manufacturing technologies.

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Description

Learner Profile:

Learners seeking core knowledge required to work in a cGMP (Good Manufacturing Practice) (Bio)Pharmaceutical manufacturing environment. This could include those interested in transferring from another related sector such as from the food and drinks industry.

Learner prerequisites:

Candidates should at minimum have completed the Junior Cert with pass grades in at least five ordinary level subjects (including Maths and English).

Learning outcomes:

At the end of the course learners will be able to:
• The terminology associated with cGMP and the regulatory requirements of working in this environment.
• The essential facts related to relevant legal, quality, and regulatory frameworks governing the manufacture of (bio)pharmaceutical products.
• The basic principles associated with validation within a (bio)pharmaceutical context.
• The technologies associated with the production of (bio) pharmaceutical and chemical synthesis product.

Course Content:

• cGMP regulatory requirements


• The fundamentals of validation in a cGMP environment


• Quality Systems Management


• Organization and Personnel Equipment


• Control of Materials


• Production Controls


• Packaging and Labelling


• Laboratory Controls


• Documentation

Duration:

1 Day

Exam/Continuous Assessment details:

Short Exercise/Quiz (to check for understanding – not marked)

Certification / Awarding Body/Credits:

Vendor Certificate of Completion

Progression Pathway:

Possible options for progression from this course are:


Essential Skills for Manufacturing in the (Bio)Pharmaceutical Industry (AMC22205)


or accredited programmes such as:


• Certificate in Operational Excellence (Special Purpose Award/QQI Level 6: 25 Credits - AMC22150) or


• Certificate in Supply Chain (Special Purpose Award/QQI Level 6: 25 Credits - AMC22151)