FDA 21 CFR Part 11
This webinar will introduce the reasons why we have big issues with data handling and storage. What is important, should be acknowledged, and trained in a company that depends on data. Not rocket science, but common sense and organized working. The uncertainty about correctly handled and stored data.
- Planning of collecting data from information (or a frame)
- Data collection, interim storage, copying, and distributing
- Data manipulating and transforming back into information
- Data and information storage and archiving
- Business process vs. resource management
- General vs. specific guidelines
Everyone wants to do a good job. Data handling is a major part of your business process, and the employees are frustrated, because the integrity of data is not known, and the general guidelines are of no use - this is your lecture.
- Clinical Operations Professionals
- Sponsors Clinical Study Groups
- Quality Assurance Professionals
- Data Management Professionals
- Electronic Systems Developers (also Big Data)
- Service Providers (for storing and maintaining any samples or data of importance)
Willi Ramseier is currently the owner and director of QVRAM GmbH of Basel, Switzerland. As an expert in quality assurance, system validation, risk awareness, and management, Ramseier is a reputed trainer, mentor, and quality compliance officer.
Having worked at Hoffman-La Roche, he now consults across Europe as a process-validation expert at Synthes-DePuy-Johnston & Johnston Switzerland, a quality consultant and CSV advisor, and GxP Workshop Trainer for a CROs in Cologne and Dresden. He also is a teacher and lead auditor for ISO 9001:2015.
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