- 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
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.
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.
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
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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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