- Online training -
Webcode 24032460
Dr. Ralf Aubeck
gempex GmbH, Mannheim
Principal Consultant / Quality GxP Pharma Senior & Executive Dr Ralf Aubeck consults as Principal Consultant and Industry Certified GMP auditor worldwide for gempex GmbH for 5 years. He holds a doctorate in chemistry (Ludwig-Maximilians-University Munich). He has over 30 years of experience in responsible quality positions in German, American and Swiss industrial companies, with concrete experience from SME to corporate groups. Strategic and operative-pragmatic Quality Assurance including the function as technical responsible person in Switzerland, responsibility for sites in the regions of Asia and Europe are also part of this. International GxP compliance issues, U.S. FDA and EU inspection readiness are the focus of his current projects in the highly regulated life sciences industry and other GMP areas. He is familiar with the U.S. FDA topic through a high double-digit number of regulatory inspections with numerous FDA cGMP inspections. Experienced and current perspectives as auditee, coach, facilitator and translator before, during and after FDA Investigations. Ralf Aubeck is passionate about FDA and GxP.
14/03/2024
14/03/2024
09:00 am - 5:00 pm - seminarYou may ...
09:00 am - 5:00 pm - seminar
You may dial in 30 minutes before the training starts
online
online
Veranstaltung - 1,190 € zzgl. MwSt.
The participation fee includes the documentation for download, a certificate, access to the Learning Space, and technical support including pre-meeting.
SPECIAL OFFER
e-Learning: Stability Testing in the ICH Region
, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
340,00 €
Veranstaltung - 1,190 € zzgl. MwSt.
The participation fee includes the documentation for download, a certificate, access to the Learning Space, and technical support including pre-meeting.
SPECIAL OFFER
e-Learning: Stability Testing in the ICH Region
, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
340,00 €
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
FDA inspection readiness: Gain the knowledge and skills necessary to manage future FDA inspections with confidence and ease.
Your desire for the next FDA inspection: The list of deficiencies remains small because your company is "inspection-ready" prior to it?!
This seminar aims to provide you with an understanding of the parameters, approaches, and concerns of FDA inspectors, and the tools for preparing, coping, and managing those inspections in pharmaceutical facilities. It will also cover the FDA’s approach to inspections, focus areas, and the documents they will be asking for.
By the end of the seminar, you will have learned how to manage inspections efficiently and effectively, and how to present information about your quality system in the most competent and professional manner.
Benefits you can expect from attending this seminar: - Gain an understanding of the parameters, approaches, and concerns of FDA inspectors. - Learn how to prepare, cope, and manage FDA inspections in pharmaceutical facilities. - Understand the FDA’s approach to inspections, focus areas, and the documents they will be asking for. - Learn how to manage inspections efficiently and effectively.
Questions, sharing of experiences and discussion
Please send us your questions concerning the seminar topics in advance.
We will be happy to forward them to the speakers, so that they know about your training requirements even better and are able to answer your questions at the seminar.
Please send your questions to b.wessels@forum-institut.de
You are looking for this topic for several employees?
We offer the right solution at your site or in virtual format!
We also offer this seminar as an in-house seminar.
Take advantage of the proven concepts of our open seminars and bring your employees to the same level of knowledge quickly and easily.
We will be happy to send you a non-binding offer.
FORUM Institut’s all-in-one training platform uses the latest teaching methods.
All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.
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All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses. If you do not have access to the customer portal yet, you can easily register here.
On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.
Learn more about our online events here.
You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.
We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.
Overall score of all evaluations in 2022
Five stars on Trustpilot = Excellent
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