FDA 21 CFR Part 11
Learn a practical, organized approach to handling data under 21 CFR Part 11, from planning collection through storage, transformation and archiving.
Speaker
Willi Ramseier
Quality and validation consultant · QVRAM GmbH · ISO 9001:2015 lead auditor
Overview
Companies that depend on data often struggle with how it is handled and stored, and with uncertainty over whether it has been managed correctly. This 60-minute FDA 21 CFR Part 11 webinar explains why those problems arise and what a company should recognize and train its people on.
The approach is common sense and organized working rather than anything complicated. You'll follow data through its life: planning how data will be collected from information, collection, interim storage, copying and distribution, manipulation and transformation back into information, and finally storage and archiving.
The session also compares business process with resource management, and general guidelines with specific ones.
Why attend: Data handling is a major part of your business process, and employees get frustrated when the integrity of data is unknown and general guidelines don't help. This session offers a practical way forward. It suits clinical operations, sponsor clinical study groups, QA and data management professionals, electronic and big data system developers, and service providers that store samples or data.
What’s covered
- Planning how data will be collected from information
- Data collection, interim storage, copying and distribution
- Manipulating data and transforming it back into information
- Storing and archiving data and information
- Business process vs resource management
- General vs specific guidelines
Who should attend
What you get
About the speaker
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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