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.
Upcoming Webinars
By Margie Faulk
Date: May 14, 2025
By Diane L. Dee
Date: May 20, 2025
By Marcia Zidle
Date: May 22, 2025
By Bruce Lee
Date: May 23, 2025
By Dr. Susan Strauss
Date: May 23, 2025
By Justin Muscolino
Date: May 27, 2025
By Beverly Beuermann-King
Date: May 30, 2025
By Nancy Amert
Recorded Session
By Margie Faulk
Recorded Session
By Meredith Crabtree
Recorded Session
By Bob Verchota
Recorded Session
By Melveen Stevenson
Recorded Session
By Marcia Zidle
Recorded Session
By Cathy Horwitz
Recorded Session
By Bruce Lee
Recorded Session
By Beverly Beuermann-King
Recorded Session
By Cathy Horwitz
Recorded Session
By Carolyn Troiano
Recorded Session
By Don Phin
Recorded Session
By Dr. Susan Strauss
Recorded Session
By Dev Strischek
Recorded Session
By Mark Gorkin
Recorded Session
By Edwin Waldbusser
Recorded Session
By Ginette M. Collazo
Recorded Session
By Edlyn McGarity
Recorded Session
By Don Phin
Recorded Session
By Marcia Zidle
Unlock Employee Loyalty: Stay Interviews Will Keep Them Engaged Before They Start Looking Elsewhere!
Recorded Session
By Diane L. Dee
Recorded Session
By Pete Tosh
Recorded Session
By Meredith Crabtree
Recorded Session
By Rebecca Farabaugh
Recorded Session
By David Nettleton
Recorded Session
By Bruce Lee
Recorded Session
By Paul J. Cline
Recorded Session
By Dr. Susan Strauss
Recorded Session
