Indian Rocks Beach, FL 33785
(727) 642-0182
(813) 774-8657
(727) 593-3595 FAX
"Helping People Learn Compliance and Science" SM
How To Write Effective Standard
Operating Procedures
ABOUT THE COURSE
“How to Write Effective Standard Operating Procedures” is a comprehensive, one-day course focusing on the practical aspects of writing effective and practical standard operating procedures (SOPs). The course materials and techniques presented are the direct result of the instructors’ recent experiences in field. The course is a systems based approach which greatly enhances the practicality and usefulness of written documentation. Practical group exercises are used to augment the classroom instruction. This is an excellent means for all laboratory and QA personnel to learn how to write or improve the quality of their existing SOPs. Emphasis is placed on writing SOPs for procedure execution versus creating administrative type documents.
WHO SHOULD ATTEND
All laboratory and QA personnel who are actively involved in writing or modifying standard operating procedures will benefit from this course.
COURSE OUTLINE
1. The Legal and Practical Aspects of Well Written SOPs
2. Documentation and Document Control in the Pharmaceutical Industry
3. Who Should Author SOPs?
4. The Systems Based Approach to Writing SOPs
a. Creating an SOP Writing Team
b. Soliciting Individual Input
c. Process Diagrams and Flowcharts: Group Assessment
d. Creating the Written Draft
e. Subject Matter Expert Trial Execution
f. Modification and Revision
g. End User Trial Execution
h. Modification and Revision
i. Sign Off and Approval
5. The Importance of Change Control
6. Selected References
7. Where to Get Help
8. Questions and Answers
9. Group Exercises
ADMINISTRATION
The course is one day in length. Cost is $525 per person, with a five-student minimum for on-site presentation. Payment can be made by personal check, company check, purchase order, or by MasterCard, Visa, or American Express. Registration can be made on-line or via telephone.
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