In-house Training Course

Effective Quality Assurance Auditing

 – Skills to Audit Manufacturing, Laboratories and Suppliers – 

Agenda for Two-Day Seminar

Day 1

08.15-08.45    Registration & Coffee; Introductions

08.45-09.45    Auditing Skills – Introduction and Basics

• Outline of Course and Introduction to Auditing Skills
• Auditing Basics
• Audits / Definitions / Purpose / Types

09.45-10.30    Auditing Skills – Models and Systems

• Audit Methods and Models
• Quality Management Systems

10.30-10:45    Coffee/Tea Break

10.45-11.25    Workshop 1 –      Audit Methods

• Traditional Approach
• Systems Approach (FDA)

11.25-12.00    Auditing Skills – Tools and Questions

• Basic Tools
• How to Ask Questions
• What to Record

12.00-12.30    Auditing Skills – Techniques and Planning

• Use of Checklists
• Audit Techniques

12:30-13.30    Lunch

13.30-14.15      Workshop 2 –    Investigation Pathways

14.15-15.00    Auditing Skills – The Audit Process

• Pre-Audit Preparation
• Audit Planning
• Opening Meeting
• The Audit Tour

15:00-15:15   Coffee/Tea Break

15:15-15.50         Auditing Skills – The Audit Process

• Managing the Team
• Exit Meeting
• Audit Reporting
• Follow-up and Close out

15.50-16:30   Workshop 3  -    Expected Documentation for QS audits                                       

• group – Quality System + One Other System (e.g. Lab Controls, Production)

16.30-17.00    Auditing Skills – Improving the Audit Process

• Adding Value from the Audit programme

17:00-17:15    Open Forum – Questions and Answers

End of Day 1

Day 2

08.30-09.30     Auditing skills – Improving the Audit Process

• CAPAs - Adding More Value from the Audit Programme

09.30-10.30     Auditing skills – FDA QSIT inspections (CAPAs)

+ Workshop 4 –  Main components of a CAPA procedure 

10.30-10:45     Coffee/Tea Break

10:45-11:30     Supplier Audits – Why Audit API Manufacturers?

                                          (EU Directive 2004//27 – regulator’s view)

• What are the requirements of the Directive?
• How will the regulators (MHRA etc) enforce the requirements?
• What role should the Secondary Manufacturers play?
• What are the similarities with the FDA GMP requirements for APIs?
•  

11.30-12.15      Supplier Audits – EU and FDA Expectations of API Manufacturers

• What are the expectations from the API manufacturers?
• Interpretation of ICH Q7a / EU GMP Guide, Part II
• Best Use of Limited Time during Routine Supplier Audits

12:15-13.15      Lunch

13.30-14.00      Workshop 5 –  How to Identify and Select a GMP Compliant API Supplier

14.00-14.45     Supplier Audits – Implications of EU Directive 2004/27/EC on Drug Product Manufacturers

• Developing requirements
• Risk assessment
• Assessment of potential suppliers
• Resource and cost implications - supplier auditing
• Decision making and managing risks
• Developing contracts
• Maintenance/policing GMP compliance at the supplying site
•  

14.45-15.15      Workshop 6 –    Auditing QC Laboratories

• Instrument validation/calibration
• Method validation
• Data Handling
• Certificates of Analysis

15:15-15:30     Coffee/Tea Break

15:30-16.45     Supplier Audits – What to Expect when Auditing an API Manufacturer

• Documentation and systems
• Facilities and support services
• Validation activities
• Control of Materials
• Calibration
• Testing laboratories (QA/QC)
• Packaging and labelling
• Storage and distribution

16.45-17:00         Parked Questions

Final Questions and Round Up

End of Course

Speaker

Dr David Inglis