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
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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 1-800-856-2556 for pricing.
SPECIAL OFFER: The SOP Web Seminar Series includes six separate offerings:
Preparing for SOP Inspection: An Auditor's Perspective (July 23, 2012 and November 21, 2012)
Procedural Document System: Organized Development (July 31, 2012 and October 23, 2012)
SOP on SOPs and Procedural Document Templates (August 16, 2012 and October 24, 2012)
Writing SOPs and Procedural Documents: Strategies for Creating Readable Documents (August 22, 2012 and October 31, 2012)
Key Strategic Steps for Developing Global SOPs (September 24, 2012 and November 8, 2012)
Implementation of Procedural Documents (October 18, 2012 and December 5, 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 hour (0.1 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#: 0778-0000-12-068-L01-P. Released: 8/12.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.