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Good Practices (GxP) in Drug Development and Manufacturing
Course Summary
This short entry-level module introduces the learner to good practices (GxP) in drug development and manufacturing. It outlines how the industry operates and how it is regulated. It identifies regulatory authorities and other important sources of guidance on Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).
Purchasing Information
When you have completed your course order, Zenosis will finalise the setup of your course materials and contact you on the email address that you provide in your order. You can expect this process to be completed within one business day (using the UK business calendar) of completing your payment.
It is therefore essential that you use your real email address for your order, or indicate in the purchase notes the email address to be used for the course set-up, and check that any messages from Zenosis or grapl are not lost in your junk or spam folder.
You will have access to the course module(s) for a period of 180 days after your purchase is complete.
Detailed Course Information
Learning Objectives
• Outline the process of drug development and manufacture
• Outline the regulation of the industry
• Identify important sources of GxP laws and guidance
Who will benefit from this course
All entry-level staff in the pharmaceutical and biotechnology industries will benefit from this module.
Module Outline
• Drug development and manufacturing
– This session outlines the process of drug development and manufacture, from the discovery of new molecules, through nonclinical studies and clinical trials, to marketing approval application, manufacturing scale-up and quality management, and pharmacovigilance.
• Regulation of the industry
– This session outlines the regulation of the industry, introducing the learner to regulatory authorities and other sources of guidance on GMP, GCP and GLP.
• Assessment
– Multiple-choice mastery assessment.
Roles
Entry-level personnel
CPD Points
TBC – points will be retrospectively awarded to learners once the course grading is completed
Region
Level
Foundation, Introductory
Course Study Time
Approx 30 minutes
USA, Europe, Other