Dr Wolfgang Schumacher
SPC – Schumacher Pharma Consult, formerly F.Hoffmann-La Roche
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
The shortcut is aimed at managers and employees of pharmaceutical and medical technology companies and their suppliers, who are accountable to implement the current requirements for data integrity in an inspection- proof manner.
Zielsetzung
During an inspection by the local or international Health Regulatory Bodies, all organisational and technical measures taken to ensure data integrity in the company must be demonstrated. It is necessary to show a clear structure of these activities together with the internal controls established, for example by QA. All measures should be planned on a risk-based basis, i.e. taking into account the risk for the product, the process and the patient; pragmatic approaches will help to keep the additional costs incurred under control.
The shortcut will emphasize on many of the issues that could be addressed during an inspection and provide participants with appropriate solutions to ensure a successful inspection. Important topics are in particular:
The shortcut will emphasize on many of the issues that could be addressed during an inspection and provide participants with appropriate solutions to ensure a successful inspection. Important topics are in particular:
- Inventory of the Systems
- Analysis of the DI Status / GAP Assessment / Data Governance
- Risk Assessment / Action Plan
- What do the Inspectors Want to See - OverviewAudit Trail Review
- Stand-Alone Systems
- CAPAs
- Inspection Observations
Programm
The aim of the shortcut is to provide answers and guidance to the following questions for practical application:
- What is the Best Way to Present DI Measures Taken?
- Risk-based Assessment Approach
- Involvement of the Management
- Audit Trail Review
- Inspection Observations of the FDA and European Authorities
Course Material
The participants will receive an Excel sheet including the corresponding check/question list to assess the Data Integrity risk of their electronic Systems
The participants will receive an Excel sheet including the corresponding check/question list to assess the Data Integrity risk of their electronic Systems
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 Andreas Mangel, +49 6221 84 44-41, mangel@concept-heidelberg.de
Questions regarding Organisation:
Mr Ronny Strohwald, +49 6221 84 44-51, strohwald@concept-heidelberg.de
Duration of the shortcut: 1h 30m
Recorded in July 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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