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What and why
Course Summary
Good Manufacturing Practice (GMP) is a set of rules for medicines manufacturers to follow so that their products are safe, effective, and of good quality. Everyone who works in a processing, quality control, packaging, or warehouse environment for a pharmaceutical or biotechnology company, or one of their contractors, must understand why GMP is important, how it applies to them, and how to comply with it. This short course explains what GMP is and why it is important, and it gives some lessons from history. It introduces the regulations and guidance documents that are the source of GMP rules. Finally, it touches on regulatory inspections and the consequences that can arise from failure to comply with GMP requirements.
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
• Explain what GMP is and why it is important
• List some historical events resulting from failures in manufacturing
• Identify sources of GMP rules in regulations and guidance
• List costly consequences of the discovery, by regulators, of serious breaches of GMP
Who will benefit from this course
Everyone who works in, or has occasion to enter into, a manufacturing environment in the pharma/biotech industry should have access to this module.
Module Outline
Roles
Manufacturing personnel
CPD Points
No
Region
Level
Foundation
Course Study Time
Approx 30 minutes
USA, Europe, Other