LIVE webinar on How to prepare for an inspection
Date: Monday, 22 September 2014
Time : 10h00-11h00 am Central European Summer Time (CEST)
Duration: about 60 minutes
In 2013, the EDQM carried out 34 on-site inspections, mainly in Asia, with the participation of GMP inspectors from different European Economic Area (EEA) countries or countries with which the EEA has a Mutual Recognition Agreement (MRA) in the field. The EDQM inspection programme is an integral part of the Certification procedure and is aimed to verify compliance with both Good Manufacturing Practices (EU GMP Part II and relevant Annexes) and the Certificate of Suitability (CEP) application at the sites covered by CEPs.
The aim of this webinar is to provide manufacturers with a greater understanding of the EDQM inspection programme, how it works and what to expect. It will cover topics such as understanding GMP requirements and gathering evidence of compliance, preparing your site, managing the inspection on the day, what the inspectors are looking for or interacting with the inspectors. Furthermore, it provides information on the follow-up of inspections, possible outcomes and their consequences.
The webinar will be provided by, Dr Thomas Hecker, Inspector, EDQM’s Certification Division. Dr Hecker is in charge of organising and conducting EDQM inspections of manufacturers of active pharmaceutical ingredients. Furthermore, he represents the EDQM in the meetings of the EMA’s GMDP Inspectors’ Working Group and the ICH Q7 Implementation Working Group.
The webinar is designed for those working in the area of Active Pharmaceutical Ingredients manufacture, quality control and quality assurance.
Important: Webinar participants located in USA, India and China can use a TOLL FREE telephone number. All other participants can listen either via VoIP or via a long distance call (chargeable by your service provider).
No special software is necessary for the webinar. If you wish to connect to audio using VoIP (Voice over Internet Protocol) you will need a fast Internet connection, a microphone and speakers. A USB headset is recommended. The VoIP connection is free. You are strongly advised to consult with your IT Department to ensure your computer can receive the webinar.
The Registration Fee is 150 EUR per delegate.
Space is limited, sign up today!
By Fax or email:
Please complete this registration form and send it back to the Public Relations Division by:
Fax: +33 3 88 41 27 71
Email via the EDQM HelpDesk
Before registering, read:
Terms of Supply for EDQM Events
If you have any queries about registering or require further information, please contact the EDQM's Public Relations via the EDQM HelpDesk.