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 Diane L. Dee
Date: April 16, 2024
By Carolyn Troiano
Date: April 16, 2024
By Jeff Kasoff
Date: April 17, 2024
By Marcia Zidle
Date: April 18, 2024
By Don Phin
Date: April 18, 2024
By Justin Muscolino
Date: April 19, 2024
By Mark Gorkin
Date: April 22, 2024
By Bruce Lee
Date: April 23, 2024
By Diane L. Dee
Date: April 23, 2024
By Margie Faulk
Date: April 24, 2024
By Harold Levy
Date: April 25, 2024
By Dr. Susan Strauss
Date: April 26, 2024
By Marcia Zidle
Date: April 29, 2024
By Carolyn Troiano
Date: April 29, 2024
By Justin Muscolino
Date: April 29, 2024
By Mary Gormandy White
Date: May 1, 2024
By Pete Tosh
Date: May 1, 2024
By Audrey Halpern
Date: May 1, 2024
By Ben Currie
Date: May 1, 2024
By Diane L. Dee
Date: May 2, 2024
By Margie Faulk
Recorded Session
By Miles Hutchinson
Recorded Session
By Deborah Covin Wilson
Recorded Session
By Donna K Olheiser
Recorded Session
By Catherine M. Mattice
Recorded Session
By Neil Malek
Recorded Session
By Deborah Covin Wilson
Recorded Session
By Ray Graber
Recorded Session
By Janette Levey Frisch
Recorded Session
By Paul J. Sanchez
Recorded Session
By Catherine M. Mattice
Recorded Session
By Danielle DeLucy
Recorded Session
By Lisa Marsden
Recorded Session
By E. Pete Lewis
Recorded Session
By Mike Thomas
Recorded Session
By Deborah Covin Wilson
Recorded Session
By Jeff Kasoff
Recorded Session
By Candace Curry Leuck
Recorded Session
By Loren Gelber
Recorded Session
By Rebecca Staton-Reinstein
Recorded Session
By Marcia Zidle
Recorded Session
By Paul R Hales
Recorded Session
By Paul J. Sanchez
Recorded Session
By Margie Faulk
Recorded Session
By Deborah Covin Wilson
Recorded Session
By Lisa Marsden
Recorded Session
By Michael D Haberman
Recorded Session
