Programme
Introduction to the ECA GMP-Auditor Association and the updated GMP-Auditors Reference Handbook
- Brief history
- New chapters and attachments
- Possibilities for information sharing
40 Years of Audit, Inspection and MHRA Experience
- Personal highlights of an experienced inspector
Discussion: How an Auditor can use AI
- How to use AI in audit planning and reporting
- Considerations and challenges
When Audits go wrong: Rights and Limits of the Auditor
- Limitations of authority — auditors are not regulators
- Rights and duties of the auditee
- Misconduct: what can “go wrong” during an audit?
- Legal consequences of misconduct (breach of contract, crossing legal boundaries, lying, intrusive behaviour, defamation, etc.)
- Documentation of misconduct
- What to do when criminal behaviour is revealed during an audit?
Auditing Global Supply Chains with cultural and regional Differences
- How auditing styles and expectations differ in Asia, EU, US, and how to adapt without compromising standards
- How auditors can manage ethical dilemmas
- How experienced auditors detect hidden problems through body language, resistance, or “too-perfect” documentation
- Different expectations of auditors in different countries: How can a uniform audit approach be applied in different subsidiaries?
Presentation and interactive Session: How to audit AI Providers and AI Applications
- Regulatory Background
- How to audit AI providers
- How to audit AI applications at a manufacturer
- Types of AI applications in GMP
- Key audit focus areas
- Prompting, testing, documentation and records
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the complete programme as a PDF.
Parallel Sessions (Experience Sharing and Discussions)
You will be able to attend 2 of these sessions per day. Please choose the ones you like to attend when you register.
Day 1
How to deal with difficult Situations in Audits
- Recognizing and managing difficult audit situations
- Strategies for managing difficult situations
- Handling specific scenarios (with examples)
Successful Self-Inspections and Internal Audits
- Preparing, conducting, reporting
- Common pitfalls and how to avoid them
- Promoting a culture of continuous improvement
Stay up to Date: Digital Proficiency needed
- Digital proficiency and the ability to audit digital data and its analysis
- How to audit:
- Paperless eQMS
- Electronic batch records
- Digital life cycle management
Day 2
Categorising/Summarising Observations
- Observation writing
- Categorising and summarising observations
- Common pitfalls and misunderstandings
How to audit brand new Facilities without a Quality History
- How to prepare
- Key audit focus areas
- Documentation and evidence expectations
- Auditor approaches and strategies
How to utilise Hybrid and Distant Assessments in the Audit Plan
- Strategic Integration into Audit Planning
- Planning a Hybrid or Distant Assessment
- The usage of e-auditing tools (e.g. smart glasses, dashboards), virtual tours and other interactive remote auditing models
- Documentation and reporting