Barnett International's Core Curriculum courses are comprehensive role-based clinical research training programs designed to provide industry professionals with hands-on training in a dynamic virtual setting. Held four times a year during our “Clinical Research Training Weeks,” courses offer clinical research-focused, performance-based training and core competency development.
How to Write Great SOPs and Work Instructions
Upcoming Courses
Standard Operating Procedures (SOPs) and Work Instructions are of high value when they are written properly. Too often authors leave out the right details to make these documents user-friendly and add-in items can cause confusion and lead to misunderstandings and at worse, non-compliance. This course presents a best practice for developing SOPs and Work Instructions starting with the critical technique of process mapping. In this seminar, learners will be taught the various components of each document and tips on how to write effective, user-friendly SOPs and Work Instructions. Participants will have an opportunity to bring a draft SOP and/or Work Instruction to the class and obtain feedback.
This is a highly practical course with real-world tips from persons in the field who create, review, and audit these documents.
- Define an SOP, Work Instruction, and a “controlled document”
- Describe the benefits or process mapping and explain how to process map
- Create an SOP from a Process Map
- Explain how an SOP and Work Instruction are different than other procedural documents
- State the key components of an SOP and WI and explain each components purpose
- Identify three situations where the writing in an SOP/WI might expose the department to risk
- Identify three situations where the writing in an SOP/WI would require intensive maintenance and review
- Authors and reviewers of SOPs and Work Instructions
The course will be led by one of the following instructors:
Holly J. DeIaco-Smith, MS Ed.
Kirsten Morasco, B.S.
Click here for complete trainer biographies
Day 1: 8:30 a.m. – 5:00 p.m.
What is an SOP?
- Methodology for Developing SOPs
- Components of an SOP
- Dos and Don’ts of SOP Writing
- What is a Work Instruction?
- Methodology for Developing Work Instructions
- Components of a Work Instruction
- Dos and Don’ts of Work Instruction Writing
- Activity 1: Conduct a Process Mapping Session
- Activity 2: Using the map and SOP template provided, draft an SOP. Provide your SOP to your neighbor and review each other’s SOPs
- Activity 3: Create a Work Instruction for Sending email from IntraLinks Microsoft Outlook Web App
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Elizabeth Andrews at 781-972-5418 to discuss your options and take advantage of the savings.
Click here for our seminar cancellation policy
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive7 hours (0.7 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# 0778-0000-13-012-L01-P. Released 7/10.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.
