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.