writing for the fda

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.