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.

Audit (self-inspection) course