Course No 18663
There is unfortunately no recording available for this Online Training Course. However, are you interested in participating in an upcoming Live Online date of this Training Course? Or do you need any assistance on our Training Courses & Conference programme? Then simply use the following contact form to send us your request.
If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: email@example.com
For our Live Online Trainings and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Dossier Requirements for the Drug Substance – An Introduction
Requirements for the Certificate of Suitability to the European Pharmacopoeia
The European Active Substance Master File Procedure
Pharmaceutical Impurities: Residual Solvents, Synthesis-derived and Genotoxic and Elemental Impurities
How to Read and Use a CEP
API Regulatory Starting Materials: how to Defend their Choice in a Submission
Comparison of the CEP and DMF Procedure
Registration Procedures in the US and Japan – what are the Differences?
The EDQM Inspection Program
Three Case Studies
Stability Studies and Establishing the Retest Date
Dr Jan Smeets
Description of the Manufacturing Process
Dr Wilhelm Schlumbohm
Top ten Deficiencies in new Applications for
Certificates of Suitability for Chemical Purity
Dr Alma Kiso
In order to prepare the lectures and the Case Studies in an optimal way, please send your questions to special topics prior to the Live Online Training to Ms Anne Günster, firstname.lastname@example.org
She will forward your questions to the responsible speaker. Thank you in advance for your co-operation..
Registration Requirements for APIs in Emerging Countries
Variations/Changes and Life Cycle Management: in the EU, US and Rest of the World
Regulatory Procedures in Brazil and China