Approved training courses

Course description

Key Learning Objectives
As API supply chains become ever more diverse and cost pressures more acute, the pharma manager needs a keen appreciation of risk factors, design, control and monitoring of API sources. This course allows delegates to differentiate between natural variation and risk across a range of API processes, indicating the most appropriate and proportionate actions to take to mitigate any areas of concern.

You will be provided with an overview of the regulatory framework surrounding active pharmaceutical manufacturing process and be given practical guidance on the key responsibilities of the Qualified Person when approving a GMP declaration.

You will also learn:

- How to meet 2004/27/EC
- The major differences between chemical synthesis and bioprocesses; and contrasting both against drug product formulation
- How to manage change of API source
- How to audit and provide QA oversight of excipients
- How to audit and how to provide oversight of remote or contract manufacturing capabilities

The course will also allow you to make informed decisions when faced with a range of GMP non-conformances during API synthesis.

Pre-requisites

Please speak to Aimee Harding, QP Coordinator at NSF about entry requirements for both QP training and/or postgraduate qualifications.

Additional info

Training will be delivered via a combination of an instructor-led virtual classroom and self-paced learning online. Full details will be sent to you following registration.

Teaching method

Online

Duration

5 day

Cost

£2100.00 GBP (plus VAT)

Training provider

NSF International

Email

qppharma@nsf.org

Tel

01751 432999

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Use the options below to search through the growing list of chemical sciences training courses that have been approved by the Royal Society of Chemistry.


Blended Learning
Class/lab
In-house
Online