Dr Karl-Heinz Bauer, Boehringer Ingelheim
Laboratory tests are performed on active pharmaceutical ingredients, excipients and other components, in-process materials, and finished drug products. The investigation of out-of-specification (OOS) results is an important part of the work undertaken in QC-laboratories and continues to be a hot topic in authority inspections. The incorrect handling and investigation of OOS results are still frequently cited in FDA Warning Letters.
Unconfirmed OOS results (= lab errors) require a full and often timeconsuming OOS investigation with a predefined procedure to find the root cause and to define CAPAs.
Against this background, it is essential to thoroughly investigate unconfirmed OOS results and make every effort to prevent the recurrence.
This webinar is aimed at all levels of technical staff and managerial personnel dealing with OOS results. Those are for example persons working in
- Incoming goods control,
- Control of finished drug products,
- Analytical development,
- API and excipient testing,
- Contract laboratories.
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
In this webinar, you will get to know strategies to investigate unconfirmed OOS results and you will learn how to define strategic measures to significantly reduce the probability of such results.
The following topics are addressed:
- Terms, definitions and requirements to prevent errors in QC-laboratories,
- The role of quality risk management,
- Error sources and error analysis in the laboratory and strategic measures,
- Integrated error management and error culture,
- Tools for root cause analysis (Ishikawa, 5W, FTA etc.).
Recording from 21.09.2021
Duration of the recording: approx. 1.5 h