Development and Validation of Analytical Procedures for Small Molecules | Module 1: Regulatory Requirements & Guidance Documents (10237)

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 intensive training covers all aspects to be considered for the analysis of small molecules. The focus is not only on the regulatory requirements (US, Europe, ANVISA, ICH, WHO), 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.

Type of Training: The training is designed as intensive training in four modules of approx. 3 hours each, 11 hours in total. The training is not only designed for less experienced participants but is also very well suited to deepen and consolidate existing knowledge for more experienced participants. The training is provided in English.

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 book these events as a series or individually as part of your webinar contingent.

Module 1

Regulatory Requirements & Guidance Documents

• ICH | EMA | FDA | ANVISA | ASEAN | WHO | ZLG
• Ph. Eur | USP
• General Requirements Analytical Procedure Validation

Processing quality control data and data from analytical validation

• Processing of the (raw) data
• Significant figures of significant digits
• Correct presentation and documentation of the data (rounding/truncating/averaging)
• Data integrity

Duration: 160 minutes
Language: English | Handout: English

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

Webinars allow you to conveniently attend training sessions and technical presentations 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.

You can also book all parts of the series at a special price. To do so, select the series in our course calender.

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

For group enquiries, please contact us directly at info@alphatopics.de.