Kane Edgeworth
Biomap
Referierende
Shortcuts: compact learning units of 1–3 hours – perfect for a quick overview or a focused deep dive into a specific topic. Book online, receive access within minutes and benefit from 7 days of on-demand availability, giving you maximum flexibility in your day-to-day work.
Compact. Flexible. Immediately available.
Zielgruppe
This shortcut is designed for all managers, supervisors, technical staff, Responsible Persons (RP’s) and other employees who are involved in the compliant storage of temperature sensitive pharmaceutical products within a GxP environment. It will be of interest in particular for personnel from the following departments:
- Quality Assurance
- Validation
- Engineering
- Logistics
- Warehousing
- Cold Chain
- Regulatory Compliance
Zielsetzung
Temperature qualification has long been a requirement for areas used for the storage of pharmaceutical products and the maturing regulatory requirements have increasingly higher expectations for compliance in this area. The EU-GDP Guidelines (Chapter 3 – Premises and Equipment) provide some broad requirements but with little guidance on the ‘how to’ element, and the WHO guidelines (Supplement 8 –Temperature mapping of storage areas) goes a step further in regards to technical elements.
This shortcut is aimed at taking out the guess work of such an exercise and clearly outlining the main components of a successful and compliant qualification.
This shortcut is aimed at taking out the guess work of such an exercise and clearly outlining the main components of a successful and compliant qualification.
Programm
The aim of this shortcut is to provide attendees an overview of the qualification process and its implementation. The following topics will be covered:
- The regulatory landscape in regards to temperature qualification
- The approach to facility qualification using the IQ/OQ/PQ cycle
- How to prepare for the thermal qualification of cold storage and warehousing facilities
- How the process differs with new or existing facilities
- Corrective actions and recommendations for permanent monitoring
Weitere Informationen
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:
Dr Markus Funk, +49 6221 84 44-40, funk@concept-heidelberg.de
Questions regarding organisation:
Ms Marion Weidemaier, +49 6221 84 44-46, weidemaier@concept-heidelberg.de
Duration of the shortcut: 1h 30m
Recorded in November 2020
Please note:
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.
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.
Teilnahmegebühr
| Regular Fee*: | € 399,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
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E-Mail: info@concept-heidelberg.de
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