Standard Operating Procedures (SOPs) are defined as detailed, written instructions that permit processes to be executed uniformly. In an effort to ensure compliance with regulations and guidelines, many sponsors, CROs, and clinical research sites have developed and incorporated SOPs into their operations. Too often, however, these documents are not reviewed critically and with enough frequency to make certain the information they convey is accurate and acceptable. Although training of staff and assessment of comprehension and compliance are crucial to implementation, the content and structure of SOPs should be routinely audited to take full advantage of their purpose. In this web seminar, we will discuss approaches to evaluating SOPs to ensure they are current and compliant.
- Examine the true purpose of SOPs and systems for compliant development, implementation, and management
- Discuss the FDA’s new expectations for Sponsor/ CRO and Clinical Investigator SOPs
- 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.
Click here for complete trainer biographies
$595
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 1-800-856-2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-12-031-L01-P. Released: 3/12.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.