Handling of Foreign Particles in APIs and Excipients - Online Training Recording

 

Visible particles, insoluble particles or matter or foreign particles in Active Pharmaceutical Ingredients (APIs) and pharmaceutical excipients are  topics of great interest and of importance to the pharmaceutical industry.

A number of inspectional observations from various Regulatory Authorities related to visible particles in Drug Products and APIs has risen considerable concern. Moreover inappropriate methods of investigation, controls and preventive and corrective actions were all subjects of citations by authorities and observations by API and excipient customers.

Particles have always been present in APIs and excipients but guidance from health authorities (EMA, FDA, others) or Pharmacopoeias (e.g. EP, USP) about particles is very limited. The APIC Guidance on Insoluble Matter and Foreign Particles in APIs and the IPEC Guide on “Technically Unavoidable Particle Profile (TUPP)" are the only best practice documents so far providing guidance for a standard approach towards an appropriate control of foreign particles in APIs and pharmaceutical excipients.

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.

Please be aware: The recording does not include the Q & A sessions.

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.