GMP Auditor Training                

Course dates

11 & 12 November 2008

Venue

The Window Conference Centre, Islington London UK

Duration
2 Days

Cost

£1160.00 + VAT £203.00 - Total £1363.00

A reduced rate if booked with "How to Audit API Manufacturers"

A 10% discount is available if booked before Friday 22 August 2008

Overview
This 2 day course is aimed at Quality Assurance auditors and production management for Level 2 internal audits and supplier auditing.

To be a business benefit rather than a drain on resources, your auditing programmes must be integral to continuous improvement.  The key to effective internal auditing and auditing of suppliers is the training of both auditors and auditees in the purpose and relevant techniques of the audit and how these techniques can be channeled to achieve business and compliance improvements.

Participants will learn about the key techniques and thought processes which may be used by auditors to maximize the benefits of each type of audit.  These include planning and preparation, the audit team, structuring the audit, close out, CAPAs and follow up.

Who should attend?

  QA auditors and trainees

  Production managers who receive internal QA and corporate GMP audits

  Engineering managers who receive internal QA and corporate GMP audits

  Production supervisors who lead Self Inspection audits

  Auditors  of suppliers and contractors

Course Speaker

Dr David Inglis

David is director of Ulverston GMP Consulting Ltd, specialising in GMP/Quality Assurance for the manufacturing sectors of the pharmaceutical and consumer healthcare industry.  He has extensive experience in assessment and improvement of QA/GMP systems, auditing, GMP training, inspection preparation and plant cleaning / decontamination, especially in bulk intermediates and APIs.  He has a Ph.D. degree in enzyme chemistry (affinity chromatography).

During more than 29 years in Quality Assurance in the pharmaceutical industry, Dr Inglis has gained extensive experience of Quality Management, through roles in QA laboratories, GMP compliance and regulatory compliance.  He successfully pioneered automated HPLC methods, then managed all aspects of QC laboratories before spending the following 11 years managing and developing Quality Assurance, including documentation, control of change, auditing and routine regulatory compliance to cGMP. He is a Qualified Person under EU Regulations, formerly for bulk sterile antibiotics and now for bulk product intermediates for use in clinical trials.

Dr Inglis is an experienced international auditor of suppliers and contractors and has successfully prepared several sites for FDA/MHRA inspections, including FDA “Systems” based inspections. He has extensive experience of being the lead spokesman during major regulatory audits.

Dr Inglis is a specialist in cGMP training and QA system improvement.  His

Course Programme

Day 1

Part 1:   Auditing Basics

:Reasons for audits and audit models (overview)

:The Purpose of Audits

:Role Characteristics of the Auditor

:Audit Types

:Audit Classification

:Audit Methods

:General Themes for All Audits

Part 2:   Auditing Tools and Techniques

:Basic tools

:Audit Techniques

:Audit Planning

DAY 2

Part 3:   The audit process

:Audit scheduling

:Conducting the audit

:Managing the Audit Team

:The Exit Meeting

:Audit Reporting

              Audit Closeout

Part 4:   Improving the audit system

:Adding Value from the Audit programme

Part 5: Added Value from Self Inspections (Level2 – QA Led)

:A practical Level 2 inspection programme (based on Auditor Training)

:Purpose of the self inspection programme

:Establishing the programme

:Setting up and training the inspection team

:Conducting the inspection and reporting

The course will include three or four Workshops on specific aspects of Parts 1 to 4