- Online training -
Webcode 24102463
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.
15/10/2024
15/10/2024
09:00 am - 5:00 pm - seminar
You may dial in 30 minutes before the training starts
online
online
Event - 1,190 € plus tax
The participation fee includes the documentation for download, a certificate, access to the Learning Space, and technical support including pre-meeting.
Event - 1,190 € plus tax
The participation fee includes the documentation for download, a certificate, access to the Learning Space, and technical support including pre-meeting.
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:
09:00 Welcome, expectations, introduction round
09:15
10:15
13:00
14:15
15:00
16:00
16:30 Questions, sharing of experiences and discussion
17:00 End of the event
You are looking for this topic for several employees?
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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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Learn more about our online events here.
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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.
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