GMP for Manufacturers of Finished Pharmaceuticals

GMP for Manufacturers of Finished Pharmaceuticals

Half Day Training Course 

Background

EU rules governing the production of medicinal products require that all staff involved in pharmaceutical product manufacture receive on-going training in Good Manufacturing Practices. This half day course provides overview training on the need for GMP, the specific EU GMP requirements & the role the Competent Authority has in ensuring that these requirements are met.

Learning Outcomes

On successful completion of this training course, delegates should be able to:

• Understand the EU GMP requirements outlined in ‘The Rules Governing Medicinal Products in the European Union’
• Understand the role the Competent Authority has in auditing the Pharmaceutical manufacturer 

Who Should Attend

Any person within the organisation  involved in  pharmaceutical product manufacture, testing or distribution 

Course Programme

• Introduction to Quality Management Systems.
• An overview of EU GMP requirements
• Principles of Internal Audit or Self-Inspection.
• Typical citations observed.
• FDA Approach to Inspections.
• Recent Enforcement Actions. 

Course Times

9.00am - 1.00pm

In-House Courses

For In-House courses, the tutor will contact you in advance to discuss the course programme in more detail in order to tailor it specifically for your organisation.

Course Manual

Delegates will receive a very comprehensive course manual.

This course is available exclusively on an In-House basis.