A course to ensure the company consistently and effectively manages deviations to ensure problems are solved and stay solved

Key topics

Deviation – problem definition, data gathering
Root Cause Analysis – using the appropriate method
Effective CAPA
Achieving a state of control
Exercises to embed learning

Course objectives

Ensure all staff have the tools to manage all unexpected occurrences effectively
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:

Have an appreciation of the importance of applying deviation management and CAPA management correctly
Have the ability to accurately record deviations, gather data, identify cause and effect and ensure problems ‘stay solved’
Be able to confidently supply all relevant information to assist with problem resolution
Understand the relevance of quality risk management in identifying problem areas before they occur
Have a greater understanding of the individual’s role in achieving a state of control within the company

Special features

The courses will be presented by the SeerPharma UK team, comprising of former MHRA Inspectors and industry experts.
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 SeerPharma UK Closed Group Members contact Debra.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.

Deviation, CAPA and Root Cause Analysis