Audience

This course is suitable for all pharmaceutical professionals, including newcomers to the industry, who wish to gain a solid knowledge and understanding in the essentials of pharmaceutical GMP.

Duration

1 day

Objectives

By the end of the course you will be able to:
• Find your way confidently around the EU Guide to EU GMP and how it is applied in the UK as the Orange Guide
• Understand the expectations of current good manufacturing practices, and how these can be achieved at a practical level in the manufacture of pharmaceutical products

Content

This interactive course examines why we have Good Manufacturing Practice (GMP), its legal status and the key GMP issues surrounding pharmaceutical manufacture such as documentation, training and facilities. This informative course introduces the EU Guide to GMP and considers its implementation in the modern pharmaceutical regulatory environment.

• Expectations of Medicines
• Why do we have GMP? What’s involved?
• Pharmaceutical Quality System
• The EU Guide to GMP and the US CFRs
• GMP - who is involved? Roles of key personnel and their departments
• Documentation - what are the GMP requirements?
• GMP in the warehouse and dispensary
• GMP in production and packaging
• People and Training
• Introduction to Deviations

Cost

Non-Member - £695 + VAT
One Nucleus Member* - £556 + VAT

*Please email training@onenucleus.com for the ON member discount code.

Training provided by

Tel: 0118 918 4076
Email: bookings@rssl.com