Shortcut: ECA Guide for the Evaluation and Investigation of Microbiological Deviations
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Target Group
- Quality Assurance
- Quality Control
- Microbiology
- Contract Labs
- R&D
- Authorities
Objectives
For this reason, the Pharmaceutical Microbiology Working Group of the ECA decided two years ago to prepare a supporting document that provides guidance on how to deal with such microbiological deviations based on the experience of its members and regulatory expectations. After the first chapter “Guidance for deviation handling of microbiological environmental monitoring excursions in non-sterile pharmaceutical manufacturing”, which has already been published, the second section, Endotoxin Testing Lab Investigations - OUT OF SPECIFICATION (OOS)/OUT OF TREND (OOT)/ATYPICAL RESULTS INVESTIGATIONS is finalized now and will be published shortly.
Programme
- Out of Specification (OOS)/Out of Trend (OOT)/Atypical
- Results Investigations
- Creating the Investigation Process Parameters
- OOS vs Invalid
- Performing the Laboratory Investigation
- How to use data generated by your company to proactively prevent OOS
Further Information
The purchase process for the GMP & GDP Shortcuts is handled via the sales platform Digistore24 (www.digistore24.com). Please understand that it is not possible to place an order on account in this case.
By clicking the “Book now” button at the top right, you will be redirected to Digistore24. After successful payment, you will automatically receive a confirmation email from Digistore24 and an email from Memberspot (our streaming provider) asking you to register.
Afterwards, you will have access to the purchased video for 7 days.
Please note: The booking is valid only for the registered participants. The use by other persons is prohibited and constitutes an infringement of copyright.
Presentation and certificate:
Starting from the purchase date, the presentation will be available for you to download in Memberspot for 7 days. Afterwards, the participants can download a certificate of attendance.
Contacts
Questions regarding content:
Mr Axel H.Schroeder, +49 6221 84 44-10, schroeder@concept-heidelberg.de
Questions regarding Organisation:
Ms Isabell Helm, +49 6221 84 44-49, helm@concept-heidelberg.de
When you click on “Register”, you will be redirected to www.digistore24.com. Once your payment has been successfully completed, you will immediately receive 7 days’ access to the Shortcut you ordered via the Memberspot streaming platform. We kindly ask for your understanding that payment by invoice is not possible.
Costs
| Regular Fee*: | € 399,- |
(All prices excl. VAT). Important notes on sales tax.
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Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
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