Development and Validation of Analytical Procedures for Small Molecules | Compact Training | English (10230)

Compact overview of the requirements and current developments (about 190 minutes - Available in German or English)

Background: The development of appropriate analytical procedures and their validation, if applicable with subsequent transfer to routine laboratories, is one of the essential prerequisites for pharmaceutical quality control of active substances and medicinal products as well as drug-related products such as food supplements and medical devices. The training covers all main aspects to be considered for the analysis of small molecules. The focus is not only on the regulatory requirements, but rather on their practical implementation. A special focus is on current developments such as life cycle concepts and the new requirements for analytical validation in the US USP. Most of the aspects will be covered using HPLC as exemplarily testing procedure.

Format of Training: With this compact training, you receive the content in an e-learning format. You can listen to and watch the lecture comfortably on your computer screen. Conveniently, no matter where you are. Since it is a recording, you can choose and schedule your own training times and interrupt at any time if necessary.
Via the email address fragen@alphatopics.de you can ask questions to the trainer at any time by email and get them answered - if necessary, also by phone. This is included in the training fees. The presentations will be made available to you after booking as PDF files together with your certificate of attendance (if required).

Who should participate? Personnel in R&D and QC laboratories for the testing of active substances and pharmaceutical products, medical devices and food supplements. Members RA-CMC teams implementing analytical, validation and stability testing data into the dossier. Quality assurance personnel with focus on analytical laboratory and related responsibilities.

We can offer you favourable graduated prices for group training courses. Please contact us.
You can also book these events as part of your webinar contongent - for this we deduct three units per person.

Content

• Regulatory Requirements (US | EU | WHO | ICH | Ph. Eur. | USP)
• Validation Parameters and acceptance Criteria
• Statistical Concepts for Acceptance Criteria - Recent Developments
• Transfer of Analytical Procedures

Duration: ca. 190 minutes

Language: English | Handout: English

...more from your speaker Dr. Markus Veit...

Webinars allow you to participate in training courses and lectures conveniently from anywhere at any time. They are the perfect way to keep up to date with the latest knowledge without much effort. You are also welcome to ask the speaker questions after the webinar.

Note on contingent call-off: When booking this webinar described here, two units will be deducted per participant.

For team training, please contact us.