This course is accredited for 7 CPD hours

Quality Risk Management

A course designed to help you develop and understand the correct use of the Quality Risk Management in pharmaceutical distribution. The course follows the ICHQ9 model, is recommended by the Good Distribution Practice (GDP) Guidelines. ICHQ9 was updated in 2022, special attention is now paid to formality, decision-making, and subjectivity. The course is led by former MHRA GDP Inspectors and is designed to be interactive. Candidates are able to work through practical examples as well as network with other professionals in the pharmaceutical supply chain.

Key topics

Hazard Identification
Risk Analysis
Risk Evaluation
Risk Reduction
Risk Acceptance
Risk Review
Achieving a state of control
Exercises to embed learning

Course Objectives

Ensure all staff can competently use Risk Management tools to achieve a continued state of compliance.
Generate the right attitudes to support a compliance-driven approach and skill set
Enable interaction with a former MHRA inspector to support decision making

Expected Course Outcome

The learner will:

Be able to apply the principles of quality risk management to identify problem areas before they occur
Understand their role and how this fits in with company expectations
Have a greater understanding of their role in achieving a state of control within the company
Effectively discuss risk management decisions with the inspector

Special features

Former MHRA Inspector led sessions and exercises.
Practical, pragmatic approach to training, using real-world examples.
All delegates will receive comprehensive course documentation.
Certificate of Attendance issued by the trainers.
Interactive learning approaches, with open questions

Training audience

The Training Course is designed for the Responsible/Designated Persons, persons involved in Logistics and QA or any personnel involved in the distribution of pharmaceuticals.

LinkedIn SeerPharmaUK Closed Group Members contact aDebra.Stanfield@seerpharma.co.uk

Prices

Prices are displayed without VAT. VAT will be added at the point of registering for a course.

Outside the UK? Contact Debra.Stanfield@seerpharma.co.uk for VAT-free registration.

Quality Risk Management in Distribution