Sprecher
Birgit Bigga
Hermes Pharma GmbH
Michael Fleischer
World Courier
Mag.pharm. Andreas Kraßnigg
Austrian Agency for Health and
Food Safety (AGES)
Dr Martin Melzer
Chemgineering Business Design GmbH
Zielsetzung
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
Hintergrund
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.
Zielgruppe
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.
All participants will receive:
the current GDP-Guidelines as a handy Paperback
an SOP on Self-Inspection
a Checklist for GDP-Compliance
Programm
Regulatory Part:
Overview: Regulatory Requirements and Guidance
EU-GMP Guidelines
EU-GDP Guidelines
Other Guides
Who needs to audit?
Expectations of the Authorities
Regulatory Inspections and typical GDP Deviations
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
General Part:
Audit Management in Distribution
Part 1: Planning the Audit
Evaluation of the distribution chain/ Risk based planning
Audit planning and resource planning
Auditor training and qualification
Part 2: Conducting the Audit
Aide Memoire vs. Checklist (benefits and risks)
Audit strategy during the audit
Audit report and classification of findings
Part 3: Audit Follow-Up
Follow-up of corrective/ preventive actions (CAPA)
Development of Key Quality Performance Indicators (KQPI)
CAPA efficiency evaluation in the follow-up audit
Practical Part:
Auditing and Qualifying Service Providers
A look behind the scenes: what can go wrong
Challenges
Examples and possible solutions
Communication Skills
The challenge of appropriate communication
How to recognise, understand and solve conflicts
Body Language
Questioning Techniques
Workshop:
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
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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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