This webinar will introduce best practices in electronic recordkeeping for the Pharmaceutical, Medical Device, and other human health sectors. We will discuss best practices that can be established before the point of data collection and throughout data storage and maintenance to ensure compliance according to FDA 21 CFR Part11. This webinar is suitable for all partners and stakeholders at any stage of data collection, retention, or transmission.
Any electronic data in the medical or pharmaceutical fields, whether collected for treatment or research purposes, must be collected and maintained to rigorous standards for privacy and accuracy. Recordkeeping processes must be in compliance with applicable regulations, and the time for establishing those processes for your company or practice is well in advance of any data collection.
This webinar will describe best practices for collecting, using and storing electronic records and samples. We will pay particular attention to the requirements set forth by FDA 21 CFR Part11, a longstanding Federal Drug Administration (FDA) regulation often used as a benchmark by health industry data specialists.
Data is the liquid gold of today's economy. The costs of mishandling, losing, leaking, or otherwise circumventing best practices, and industry regulations for data can be devastating, for both reputation and the bottom line. Failure to gather necessary permissions from the original owner and provider can affect liability and data integrity.
Whether your role involves;
This webinar will address your questions about how important your part is in this process loop, and how you can help the company safeguard resources and remain fully compliant.
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.