Event Date/Time: May 19, 2010 End Date/Time: May 20, 2010
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Description

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
GMP and compliance

GMP Auditor Training
GMP in primary (API) manufacturing
GMP in secondary (product) manufacturing
Writing effective SOPs in a
GMP environment
Pharmaceutical Documentation – a practical approach
OOS investigations in a
GMP environment
How to Audit API Manufacturers
Pharmaceutical product development
Integrated Tablet Formulation Development
Tablet Process Development, Validation and the application of QbD
Development and Manufacture of Effervescent Tablets
Stability Testing in Pharmaceutical Development and Manufacture
Introduction to Photostability
Pharmacokinetics in Drug Development - an integrated approach
Analytical Method Development and Validation
Hands-on Tabletting
Active pharmaceutical ingredients - development, supply and commercial manufacture
Pharmaceutical manufacturing support

Technology Transfer
Supply Chain Risk Management and Compliance for QPs and RPs
Pharmaceutical R&D support

‘Molecules to Market’ – navigating the development maze
Team building and
decision-making
Managing pharmaceutical development projects
In-house training courses

GMP auditor training
keeping you ahead of the gameGMP and compliance - GMP auditor training

Venue

Types