Development and Validation of Analytical Procedures for Small Molecules | Module 2: Basic requirements and validation prameters
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 2
Basic requirements and validation parameters
- Parameters to be validated
- Verification of compendial methods
- Acceptance criteria (with different regional requirements)
- Descriptive statistics
- Equivalence versus significance tests
- Single versus multiple determinations
- Setting of acceptance criteria
- OOS | OOE | OOT
Duration: 180 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 ourcourse calender.
Note on contingent call-off: When booking this webinar described here, two units will be deducted per participant.
For group enquiries, please contact us directly at info@alphatopics.de.
- Dr. Markus Veit
ALPHATOPICS GmbH
E-Learning | Streaming in MP4 format (EN)
Prizes & Conditions of Participation
per person plus VAT. - Payment upon receipt of invoice.
The fee includes for a single booking:
- the one-time viewing of the booked webinar/ or webinar series by the person(s) named to us in advance.
- the receipt of the slides shown as a printable PDF file.
The training is personal and, if booked individually, is for personal training purposes only - not for an entire team. We thank you for your fairness.
Cancellation or change of person is not possible after sending the handout (live: usually 1-2 days before the event | recording: immediately).
Full terms and conditions and participant information can be found here.
Consent to photographs and film recordings as well as their publication: We would like to point out that photographs and film recordings are taken during our events by persons or service providers commissioned and authorised by us for the documentation of our events (legal basis Art. 6 para. 1 lit. f DSGVO). The recordings serve our public relations work as well as the use, publication and distribution in print, digital and online media, such as newsletters, websites, brochures, flyers and social networks. In this context, it is pointed out in particular that photos and videos on the internet can be accessed by any person. It cannot be ruled out that such persons will continue to use the photos/videos or pass them on to other persons. By registering for and participating in the event, you agree that the organiser is permitted to publish photos, audio and/or film contributions taken at the event without restriction, including for advertising purposes, across all media without permission or remuneration. You have the right to revoke this consent at any time. The revocation of consent does not affect the lawfulness of the processing carried out on the basis of the consent until the revocation. This means that consent can be revoked with effect for the future. We will then immediately remove your photo/video from our website. In this case, please send your revocation to info(at)alphatopivs.de, stating the event.
Special prices for team bookings:
If the training is of interest to a group of colleagues, please contact us. Here we offer special group prices for you as a company. The group size is limited to a maximum of 30 participants per webinar. You can participate live or stream the webinar at an individual later time in our video library.
You are interested in a live event but don't have time on the scheduled day of the live webinar?
Then simply ignore the reminder emails about the live event. Our webinar platform will register that you were not present. As soon as the webinar has taken place, you will automatically receive an email from us a few hours later with your personal link to stream the webinar. You can then watch the webinar - individually - whenever your schedule allows. If you have any questions about the content, you are welcome to send them later to fragen@alphatopics(dot)de.
Note on contingent retrieval:
When booking via your company contingent, please note the separate note in the description of the webinar as to how many parts will be deducted from your contingent for the selected webinar, or webinar series.
Save money by booking a quota of 10 and combine any 10 individual webinars (90 min. each) from the topics offered.
Price: 2,500.- € per contingent plus VAT.