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. On completion of the programme learners will be able to demonstrate a foundational knowledge of quality management systems, industry regulatory requirements, validation, documentation, contamination control and manufacturing technologies.

What You Will Get:

  1. The terminology associated with cGMP and the regulatory requirements of working in this environment
  2. The essential facts related to relevant legal, quality and regulatory frameworks governing the manufacture of (bio)pharmaceutical products
  3. The basic principles associated with validation within a (bio)pharmaceutical context
  4. The technologies associated with the production of (bio) pharmaceutical and chemical synthesis product

Course Modules:

Module 1


cGMP regulatory requirements


Module 2


The fundamentals of validation in a cGMP environment


Module 3


Quality Systems Management


Module 4


Organization and Personnel Equipment


Module 5


Control of Materials


Module 6


Production Controls


Module 7


Packaging and Labelling


Module 8


Laboratory Controls



    Module 9


    Documentation



    Duration/Delivery Mode

    This is a one day online class via zoom - 9:30am to 3:30pm 

    Certification:

    Innopharma Education Certificate of Completion. 


    Digital Badge available