Standard Operating Procedures (SOPs) are detailed written instructions that allow one to execute a process uniformly. Many SOPs are not well defined or well written, and actually fall short of providing the details needed for one to complete the process. In fact, many who are assigned the task of creating SOPs lack the basic understanding of what constitutes a well written SOP. Often SOPs appear to be no more than a brief Note to File, leaving gaps in the proper execution of the task delegated. Poorly written SOPs also leave organizations vulnerable in the event of an audit. In this web seminar, FDA Warning Letters will be reviewed to demonstrate the consequences of poorly written SOPs. This course offers guidance to those who recognize they need SOPs, or more detailed SOPs, but do not know how or where to start. Participants will be provided with guidelines and templates that ensure that new and updated SOPs are uniform and user-friendly.
- Describe the purpose of SOPs
- Identify the basic elements of well written SOPs
- Design an SOP from the templates provided
- Link the SOP to other activities such as performance evaluations
- SOP Authors/Reviewers
- Research Site Administrators
- Clinical Monitors
- Study Coordinators
- Quality Assurance Auditors
- Project Mangers
Jackie Stader, C.O.T., C.C.R.C.
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Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2.5 hours (0.25 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-14-041-L01-P. Released: 3/14.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.