SeerPharma UK

This course is accredited for 7 CPD points

Audit (self-inspection) course

A one-day course designed to increase understanding and educate on the approach to self-inspections/audits and the practical techniques needed to perform self-inspections/audits.

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

• 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 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.