Deviation, CAPA and Root Cause Analysis
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
- 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 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.
Instructors
Alan Bentley
Gaynor Brummitt
Contact us
- Debra Stanfield
- de••••d@see••••a.co.uk
- 01903 730622
Location
Classifications
Categories
- ALL QMS COURSES & REFRESHER COURSES
- - Deviation, CAPA and Root Cause Analysis