SOP Writing
BASIC Options
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Expert, concise technical writing of SOPs, batch records, protocols, work instructions, etc.
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Interactive training – Effective GxP Instructions Writing - includes activities, discussion, and real-world examples that teach staff how to write concise, user-friendly, visual SOPs that reduce errors and improve performance
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SOP template development
HOLISTIC Options
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Develop SOP rubric to measure target SOPs before and after revision to ensure effectiveness
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Implement rubric and train staff how to apply it
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Develop new MS Word-based, visual, concise SOP template and implement, including coaching SOP authors as needed
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Facilitate Kaizen-style workshop for SME authors to transform SOPs using new methodology
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Note: New method can use firm’s current templates or new Word template – no new software or validation needed
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SOP writing Train-the-Trainer for skills internalization
What VALUE can we bring to your organization?
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25% - 50% reduction in deviations against target SOPs
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Massive reduction in SOP length, word count
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Reduction in review cycle and document training times
Title: Effective GxP Instructions Writing
Description
Did you know the brain processes visual information (colors, pictures, and symbols) 60,000X faster than black and white text?
This engaging course shows participants how to write clear, concise, user-friendly procedures that help end users and reduce errors and firefighting. You don’t need to be a wiz at MS Word, or any special software to do it. This course challenges the old paradigm that SOPs and other instructional documents in biopharma/device industries, must be long, wordy, black-and-white text documents. SOPs can be useful performance support tools for end users, and still be fully compliant with GxP regulations.
The session is interactive; includes group activities and writing exercises using real-world scenarios and examples to ensure participants not only learn the importance and simple techniques for great SOP writing, but can apply them as well.
Duration: 4 - 6 hours
Note: All courses can be offered in person or in virtual format using MS Teams.
