SeerPharma UK

This course is accredited for 7 CPD hours

This course equips you to plan and run effective audits from start to finish - from understanding audit structures and creating self inspection schedules to conducting audits, managing follow up actions and evaluating quality system performance. You will also learn how to implement robust CAPA measures to address any issues uncovered and strengthen overall compliance.

Key topics

• Responsibilities of the Responsible Person regarding Self-Inspections
• Audit Preparation and Planning
• Conducting and Recording Self-Inspections including exercise
• Audit (exercises)
• Audit close out and follow-up actions

Course objectives

Help understand and educate on the approach to self inspections and practical techniques needed to perform self inspections. Training is designed to help towards understanding the rules and regulations relating to Chapter 8 of the EU Good Distribution Practice Guidelines. The training and exercises are designed to be engaging and provide an insightful look into the thought process of an auditor.

Expected course outcome

• Understand the structure and mechanisms of the auditing process
• Prepare self-inspection audit schedules and programmes
• Perform an effective audit
• Manage the post-audit activities and follow-up
• Understand how to review the effectiveness of an organisation’s quality system and implement effective corrective and preventive actions (CAPA) to address any deficiencies or non-conformance issue identified

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 co-workers and Responsible/Designated Persons, persons involved in Logistics and QA or any personnel involved in performing internal audits/self-inspections.

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.