Mag.pharm. Andreas Kraßnigg, Austrian Agency for Health and Food Safety (AGES)
Dr Martin Melzer, Chemgineering Business Design GmbH
Anil Rattu, Roche
Wolfgang Schmitt, Concept Heidelberg
The EU GDP Guidelines have been extensively revised to take into account the changing nature of the globalised supply chain. One important aspect is auditing partners in the supply chain. But who needs to audit which service provider and how? And who will be inspected by the authorities? And how can I prepare myself?
In this training course you will learn
- How to plan and conduct audits efficiently
- How to prepare yourself when being audited
- How to face the various challenges
- What communication techniques are needed
- How you can avoid and solve conflicts
The revised GDP-Guidelines highlight the need for an effective quality management system and appropriate controls for all partners and service providers in the distribution chain (like manufacturers, wholesalers, warehouses and transport and logistics providers).
Qualification of these partners, like for example with audits, is a core element to implement the GDP requirements.
Initial and continuous professional training for auditors is of utmost importance as the authorities expect highly qualified personal performing audits. Therefore the ECA has developed the programme at hand to give you a detailed overview about important matters to consider and to discuss important tasks and challenges of GDP audits.
On the other hand you will learn how to prepare your company to pass an inspection or customer audit and how to assure the most positive outcome.
This education course is designed for all managers, supervisors and other staff members who are involved in audits of pharmaceutical storage, transportation, cold chain and distribution activities.
- the current GDP-Guidelines as a handy Paperback
- an SOP on Self-Inspection
- a Checklist for GDP-Compliance
Regulatory Part:EU-GMP Guidelines
Who needs to audit?
Expectations of the Authorities
Regulatory Inspections and typical GDP Deviations
- Overview: Regulatory Requirements and Guidance
Audit Management Part:
Part 1: Planning the Audit
- GDP inspections: Who will be inspected, Different kinds of inspections. Approach, Classification of audit findings
- Examples of frequent observations and typical audit findings: Storage, Transport, Wholesalers
Part 2: Conducting the Audit
- Evaluation of the distribution chain/ Risk-based planning
- Audit planning and resource planning
- Auditor training and qualification
Part 3: Audit Follow-Up
- Aide Memoire vs. Checklist (benefits and risks)
- Audit strategy during the audit
- Audit report and classification of findings
GDP Certification to Quality Oversight beyond the Audit
- Follow-up of corrective/ preventive actions (CAPA)
- Development of Key Quality Performance Indicators (KQPI)
- CAPA efficiency evaluation in the follow-up audit
The Psychology of Audits
- Preparation for the GDP audit
- Auditing and qualifying service providers: a look behind the scenes - what can go wrong
- Deviation management
- Beyond GDP - Staying ahead of the game for IVD/MDs Product Quality specifics
- The challenge of appropriate communication in an audit
- When things go wrong: conflict management
Before being audited: Conducting a GAP Analysis
- Preliminary considerations – what are the requirements? What are the expectations?
- Conducting your own GAP Analysis
- Action plan & processing
- How to keep the achieved status