Writing for the FDA
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The document discusses the Federal Food, Drug, and Cosmetic Act and the role of technical writers in ensuring compliance. It covers how technical writers create user manuals and documentation to support Good Manufacturing Practices for internal and external audiences. It also provides an overview of the multi-tiered documentation system and importance of documentation for standardizing processes, ensuring product quality, and acting as a commitment to the FDA that all processes were followed.
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Writing for the FDA
- 1. Federal Food, Drug, And Cosmetic Act By Lev Feigin, Ph.D.
- 2. Food Pharmaceuticals Biotech Medical device Cosmetics Tobacco
- 3. Sales-side. TW geared for the consumer (healthcare providers and patients) who develop user manuals for company products. Manufacturing-side. TW for internal audiences (business units, managers, employees) AND external auditors.Develop, revise and manage procedural documentation in support of Good Manufacturing Practices (GMP) mandated by the FDA.
- 4. Multi-Tiered Documentation System Policies Procedures Work Instructions/Job Aids Training Materials Forms and Records
- 5. Standardizes the business and manufacturing processes and ensures consistent product quality Required for compliance with Federal Regulations (CFR 21) Acts as a written commitment to the FDA “If it’s not documented, it didn’t happen.”
- 6. To stray from the process established by the document is to be in violation of the procedure AND the regulations. Periodically audited for compliance by internal auditors and FDA inspectors.
- 7. Pharma, Biologics and Medical Device Regulations (CFRs) Good Manufacturing Practices (GMP) Quality Assurance Documentation Management and Control
- 8. Doc Control Department Manages controlled documentation Archives, facilitates approval of new and revised documentation, and release it company-wide Document Change Control process
- 9. Learn about Quality Systems and Good Manufacturing Practices (GMP) regulations www.fda.gov
- 10. Update your TW resume to foreground procedural writing and process analysis skills
- 11. Look for tech writing jobs specifically in the pharma, biotech, medical device industries
- 12. Send your resumes to FDA Compliance Consulting Firms and Staffing Companies that work with pharma and med device clients.
Hinweis der Redaktion
- A bit of outlier specialization that is not often considered when thinking about our profession. A huge sector of the U.S. economy 1000s of companies These are highly lucrative jobs
- Food and Drug Administration Guess what?! They all need TWs
- Sales-side for Med device only All FDA-reg industries require to document all of their processes
- Tiers of procedural documentation stack up to a Doc System 1000s to 10,000s of pages
- Why this number of docs? CFR 21 Part 210