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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$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.
SPECIAL OFFER: The SOP Lunch and Learn Web Seminar Series includes five separate offerings:
Procedural Document System: Organized Development (May 31, 2012)
SOP on SOPs and Procedural Document Templates (June 1, 2012)
Key Strategic Steps for Developing Global SOPs (June 4, 2012)
Implementation of Procedural Documents (June 21, 2012)
Preparing for SOP Inspection: An Auditor’s Perspective (June 26, 2012)
Register for three sessions, and get one free! To take advantage of this special offer, call Adriana Randall at 1-800-856-2556.
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.