Anil Rattu
Roche Diagnostics
Referierende
Andreas Kraßnigg
AGES, Österreichische Agentur für Gesundheit und Ernährungssicherheit
Dr Martin Melzer
Gempex
Alfred Hunt
Hunt Pharma Solutions
All times mentioned are CET.
Zielsetzung
The EU-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).
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 live online training course you will learn
In this live online 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
Qualification of 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.
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.
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-trainingtechnical- information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
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
Audit Management Part
Part 1: Planning the Audit
- Evaluation of the distribution chain/Risk based planning
- Audit planning and resource planning
- Auditor training and qualification
Part 2: Audit Execution
- 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
Q&A sessions after each presentation ensure interaction and that your questions are answered.
Practical Part
Practical Part
The Psychology of Audits
- Understanding why people show certain behaviour
- The challenge of appropriate communication in an audit
- When things go wrong: conflict management
GDP Audits - the Devil is in the Detail
- Learning from industry experience
- How to find and handle the real problems
- Unexpected cases - different expectations
GDP Certification to Quality Oversight beyond the Audit
- 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
Diese Veranstaltung ist derzeit nicht buchbar. Alternative Live-Veranstaltungen und Aufzeichnungen finden Sie in der Gesamtübersicht. Oder kontaktieren Sie uns gerne über das Kontaktformular.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified GDP Compliance Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
Tel.: +49 6221 8444-0
E-Mail: info@concept-heidelberg.de
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