Programme

Introduction to the new ECA GMP-Working Group and the GMP Auditors Reference Handbook

• Brief history
• Members
• Output so far
• Possibilities for information sharing

How good Auditors should be trained

• Content and Design
• Internal and external training
• Experience needed
• Behavior needed

Current Developments

• What’s new in the world of auditing
• Inspection trends
• Current ways of auditing and the future of audits: Onsite, remote, hybrid
• Agents’ business practices, roles in the market

What are the Inspectors looking for?

• How do GMP inspectors evaluate a company’s audit programme
• Inspection methodologies/concepts/approaches
• Expectations for audit days and number of auditors in an audit vs. scope of the audit, type of products and activities to be covered
• Audit Reports

Auditing in the Middle East and Asia

• How EU-GMP regulations are implemented (with a focus on the new Annex 1)
• What auditors from EU could expect
• Experiences made being a female auditor in some parts – and how to overcome these

 

Parallel Sessions (Round Table Discussions)

External Information – how to use it

• Where to get the information
• Third Party Audit Reports - sources, validity of the reports
• Inspection Reports, 483s, Warning Letters
• What to learn from it

Special Challenges

• What to do if Supplier does not allow for an Audit? Or only remote?
• What to do if Supplier does only allow for a one-day Audit?
• Supplier is not willing to be audited according to API requirements although product is used as API

The Use of Checklists

A checklist should not be a substitute for proper planning and audit performance. Discuss advantages of using a well-prepared checklist and its limits.

The Use of Interpreters

• How to get good interpreters
• Challenges and pitfalls
• Experience sharing

Supplier Qualification in a changing World

Consequences of the Chinese Anti-Espionage Law

How to deal with difficult Auditees

• Limited information provided
• Documents not provided or very late
• Tour is not well organised
• Passive and uninterested representatives
• SME unavailability