21 CFR Part 11 Compliance - Ensuring Data Integrity and Safety in Clinical Research 2018 is a webinar that covers topics such as:
- What needs to happen to make data trails secure and real
- The CFR definitions of Electronic Record, Electronic Signature, Closed System, Open System, Data Trails, and assure that your data is secure and valid?
- What controls need to be in operation for an open system?
- What questions should you internal QA department ask to be sure your system is functioning correctly?
- The Role of Standard Operating Procedures and staff training in a functional Electronic Data Capture system
- What are the controls needed for a valid electronic signature?
- What are the suggested controls to ensure authenticity, integrity and confidentiality of your EDC system?
21 CFR Part 11 Compliance - Ensuring Data Integrity and Safety in Clinical Research 2018 is intended for:
- Clinical Research Scientists (PKs, Biostatisticians)
- Principal Investigators and Sub Investigators
- Clinical Research Associates (CRAs) and Cordinators (CRCs)
- Safety Nurses
- QA / QC Auditors and Staff
- Recruiting Staff
- Clinical Research Data Managers
