AGES, Österreichische Agentur für Gesundheit und Ernährungssicherheit
Dr. Martin Melzer
Gempex
Alfred Hunt
Hunt Pharma Solutions
Dr. Markus Funk
Concept Heidelberg
Objectives
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
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
Background
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.
Target Group
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 Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration: When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate: The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Programme
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
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
Recording from 13/14 December 2023
Duration of the recording: approx. 7 hours 20 minutes
This course is part of the GMP Certification Programme "ECA Certified GDP Compliance Manager" Learn more
Testimonials