writing for the fda
Post on 19-May-2015
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Federal Food,
Drug, And
Cosmetic Act
By Lev Feigin, Ph.D.
Food Pharmaceuticals Biotech Medical device Cosmetics Tobacco
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.
Multi-Tiered Documentation System
PoliciesProceduresWork Instructions/Job AidsTraining Materials
Forms and Records
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.”
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.
Pharma, Biologics and Medical Device Regulations (CFRs)
Good Manufacturing Practices (GMP) Quality Assurance Documentation Management and Control
Doc Control Department Manages controlled documentation Archives, facilitates approval of new and
revised documentation, and release it company-wide
Document Change Control process
Learn about Quality Systems and Good Manufacturing Practices (GMP) regulations
www.fda.gov
Update your TW resume to foreground procedural writing and process analysis skills
Look for tech writing jobs specifically in the pharma, biotech, medical device industries
Send your resumes to FDA Compliance Consulting Firms and Staffing Companies that work with pharma and med device clients.
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