BMED 2520 - Technical Writing for Regulated Industries

1. Create coherent text and graphic content for documents used in regulatory-compliant systems.
2. Explain regulatory-compliant electronic or hybrid system requirements for technical writing tasks applied to electronic records and electronic signature document approvals.
3. Use FDA and other regulatory agency Web sites as resources for accessing current compliance information.
4. Collaboratively develop documents using teamwork skills, writing skills, and regulatory-compliant processes.
5. Analyze documentation requirements and respond with the appropriate technical writing solutions and regulatory-compliant processes.
6. Present technical information based on best practices oral-presentations.

1. Technical writing effectiveness memo
2. Using revision software effectively Case 3 memo
3. Coherent paragraph responses
4. Revise variety of sentences
5. Exercise machine product description revision
6. Flowchart design
7. Tranform document using Information Mapping or structured technique
8. FDA enforcement categories report e-mail
9. Warning letter executive summary memo
10. 21 CFR Part 11 guidance issue e-mail
11. 21 CFR Part 11 requirements priority e-mail
12. Copyright and trademark guidelines assessement e-mail
13. National Science Foundation’s Grant Proposal Guide analysis memo
14. Government agency or department report analysis memo
15. Executive summary review and responses to questions
16. Trademark and Copyright analysis memo
17. Meeting minutes review and responses to questions
18. Laboratory notebook example or electronic notebook use memo
19. Technical information oral presentation
20. Technical instructions evaluation memo
21. One of three instructions-for-use markup sample presentation