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