Writing for the FDA

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Presented by Lev Feigin

Technical writers for FDA-regulated industries are always in demand. Such writers produce a wide array of documentation, from policies and procedures to quality manuals and employee training, which support good manufacturing practices and ensure compliance with FDA regulations. In this session learn what it takes to excel in the pharmaceutical and medical devices industries as a technical writer and find out what you’ll need to know about the latest documentation practices and requirements to enter the field.

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  • 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
  • Writing for the FDA

    1. 1. Federal Food, Drug, And Cosmetic Act By Lev Feigin, Ph.D.
    2. 2.  Food  Pharmaceuticals  Biotech  Medical device  Cosmetics  Tobacco
    3. 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. 4. Multi-Tiered Documentation System Policies Procedures Work Instructions/Job Aids Training Materials Forms and Records
    5. 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. 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. 7.  Pharma, Biologics and Medical Device Regulations (CFRs)  Good Manufacturing Practices (GMP)  Quality Assurance  Documentation Management and Control
    8. 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. 9.  Learn about Quality Systems and Good Manufacturing Practices (GMP) regulations www.fda.gov
    10. 10.  Update your TW resume to foreground procedural writing and process analysis skills
    11. 11.  Look for tech writing jobs specifically in the pharma, biotech, medical device industries
    12. 12.  Send your resumes to FDA Compliance Consulting Firms and Staffing Companies that work with pharma and med device clients.

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