Shortcut: Series Data Integrity - Preparing a Data Integrity Inspection
Concise expertise. Ready when you are.
Course No. 18189A
Speakers
Dr Wolfgang Schumacher
SPC – Schumacher Pharma Consult, formerly F.Hoffmann-La Roche
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.
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.
Objectives
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:
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
Programme
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
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.
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