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.
- Review approaches to translating the process into readable and usable text
- Discuss the “good, bad, and ugly” words and expressions to use
- Identify ways to avoid or reduce risk of regulatory compliance through better writing
- SOP Authors/Reviewers
- Quality Assurance Auditors
- Clinical Monitors
- Site Managers
- Line Function Heads
- Project Managers
Irina Colligon
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Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.