One is hard-pressed to find anyone in the drugs/biologics/medical device industry who is not aware of SOPs (Standard Operating Procedures). Unfortunately, quality and usability vary widely. Many SOPs fall short of fulfilling their role as compliance and training tools. Many in the industry view SOPs as a necessary evil; but it does not have to be so.
The goal of this web seminar series is to help attendees create user-friendly SOPs that continuously support standards for quality and validity of data, as required by the regulations, while also providing value to their users.
- Examine the true purpose of SOPs and systems for compliant development, implementation, and management
- Discuss the FDA’s new expectations for SOPs from Sponsors/CROS and Clinical Investigators (with an update on IRB requirements)
- Review recent case studies concerning issues in SOP documentation and implementation practices
- SOP Authors/Reviewers
- Quality Assurance Auditors
- Clinical Monitors
- Site Managers
- Line Function Heads
- Project Managers
Elizabeth Ronk Nelson, M.P.H.
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Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.