Fremont, California (PressExposure) May 27, 2013 -- Summary: Charles H. Pierce, a consultant in the Clinical Research/Drug-Device Development arena, will be the speaker at a webinar that MentorHealth, a leading provider of online training for the healthcare industry, is organizing on June 20. The webinar is on the topic, "How Does Compliance with 21 CFR Part 11 Help Ensure Data Integrity and Subject Safety in Clinical Research?"
This webinar is about ways by which to come up with an efficient Data/Audit Trail for system validation.
Electronic medical records and electronic handling of study data is becoming increasingly common, making involvement of computer systems in clinical research necessary. In this scenario, the researcher has to have knowledge of 21 CFR Part 11, which deals with electronic records; electronic signatures in all its depth.
The fundamental quality about electronic records and electronic signatures is that they must be trustworthy, reliable and generally equivalent to paper records and signatures executed on paper. However, there are significant differences between the traditional paper system and an electronic system.
Knowing and following the Part 11 code is vital in this scenario. The who, what, and when aspect of the Data/Audit Trail are the most important elements of system validation.
Some of the qualities of these trails are that they must be secure, operator independent, computer generated, date & time stamped, and (most importantly) available for the FDA reviewer. The most important differences between good and average systems are SOPs and staff training.
This webinar will throw light on these aspects of system validation.
It covers the following areas:
- The CFR definitions of Electronic Record, Electronic Signature, Closed System, Open System, Data Trails, and assure that your data is secure and valid?
- What needs to happen to make data trails secure and real
- What questions should you internal QA department ask to be sure your system is functioning correctly?
- What controls need to be in operation for an open system?
- What are the controls needed for a valid electronic signature?
- The Role of Standard Operating Procedures and staff training in a functional Electronic Data Capture system
- What are the suggested controls to ensure authenticity, integrity and confidentiality of your EDC system?
When: June 20, 10:00 AM PDT | 01:00 PM EDT
Charles H. Pierce, MD, PhD, FCP, CPI is a consultant in the Clinical Research/Drug-Device Development arena specializing in bringing the message of GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects.
Dr. Pierce serves as an advisor to several clinical research organizations, sits on industry based boards, and is VP of Medical Affairs for Harrison Clinical Research GmbH, a global CRO headquartered in Munich. He has been in the Clinical Research Industry for 20 years, and has been involved in developing Phase I & IIa Clinical Pharmacology Units, Investigator and staff GCP training and medical monitoring in both drug and device studies.
The webinar will benefit
- Principal Investigators and sub investigators,
- Clinical Research Scientists
- Safety Nurses
- Clinical Research Associates (CRAs) and Coordinators (CRCs)
- Recruiting staff
- QA/QC auditors and staff
- Clinical Research Data managers
Duration: 90 minutes
To enroll for this webinar, contact