Webinar Series - Deviation Management and CAPA: Regulatory background - Recording

Webinar Series - Deviation Management and CAPA: Regulatory background - Recording

Costs

ECA-Member*: EUR 199,--
Regular Fee*: EUR 249,--

(All prices excl. VAT)

* also payable by credit card American Express Visa Mastercard

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Speakers

Lea Joos, GMP-Inspectorate, Local Government Munich, Germany

Background

Things will go wrong from time to time. In the world of pharmaceuticals, we need to ensure that we have robust processes and procedures in place to deal with such situations. When an unplanned event arises it must be handled accordingly.

In any case a sound failure investigation is the key to identify appropriate CAPAs. Here it is also important to know how to deal with human error based and non-human error based non-conformances.

Independent from that, it needs to be pointed out that CAPA is an excellent Quality Management tool to continuously improve processes and avoid future failures.

ECA has now set up a series of four Webinars to discuss principles and relevant aspects to implement, improve and monitor your Deviation Management and CAPA System.

Target Group

This series of webinars is designed for all personnel involved in Deviation Management and CAPA activities at their company. It is addressed to persons from Quality Assurance and Control, Manufacturing and R&D.
Each webinar can also be attended as single Event.

Technical Details

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.

Programme

During the Webinar on Regulatory Background, Principles, Expectations of the Inspectorates we will talk about:
  • International Requirements – Rules and Regulations
    • Definitions
    • GMP requirements
    • What to do
  • Deviations in the Light of Inspections
    • Examples from the real GMP-world
    • Most frequently detected issues
Recording from 12.05.2020
Duration of the recording: about 1.5 h.

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