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

How to qualify suppliers of APIs, raw materials, intermediates, solvents etc.

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

 

 

 

Click on the picture to download the complete programme as a PDF.

 

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