Add course dates to your calendar
10/11 November 2010
Venue Window Conference Centre, London
Speaker David Inglis
Cost £1363 (inc VAT)
Early-bird rate £1226.70 (inc VAT) if paid by 03/09/2010
Discounted rate of £1861.20 (incl VAT)
if booked with How to Audit API Manufacturers
Early-bird rate £1675 (inc VAT)
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Comments from previous attendees
"David provides a good mixture of practical experience and theory"
"Very detailed with interesting comparisons of how different companies interpret GMP"
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 channelled 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
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
