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Federal Food, Drug, And Cosmetic Act By Lev Feigin, Ph.D.

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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.

TRANSCRIPT

Page 1: Writing for the FDA

Federal Food,

Drug, And

Cosmetic Act

By Lev Feigin, Ph.D.

Page 2: Writing for the FDA

Food Pharmaceuticals Biotech Medical device Cosmetics Tobacco

Page 3: Writing for the FDA

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.

Page 4: Writing for the FDA

Multi-Tiered Documentation System

PoliciesProceduresWork Instructions/Job AidsTraining Materials

Forms and Records

Page 5: Writing for the FDA

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.”

Page 6: Writing for the FDA

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.

Page 7: Writing for the FDA

Pharma, Biologics and Medical Device Regulations (CFRs)

Good Manufacturing Practices (GMP) Quality Assurance Documentation Management and Control

Page 8: Writing for the FDA

Doc Control Department Manages controlled documentation Archives, facilitates approval of new and

revised documentation, and release it company-wide

Document Change Control process

Page 9: Writing for the FDA

Learn about Quality Systems and Good Manufacturing Practices (GMP) regulations

www.fda.gov

Page 10: Writing for the FDA

Update your TW resume to foreground procedural writing and process analysis skills

Page 11: Writing for the FDA

Look for tech writing jobs specifically in the pharma, biotech, medical device industries

Page 12: Writing for the FDA

Send your resumes to FDA Compliance Consulting Firms and Staffing Companies that work with pharma and med device clients.


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CAPA for the FDA Regulated Industry

FDA Guidance for Industry

Regulatory consideration for biosimilars by fda

FDA for Procedure Validation in Food

Importance of fda approval for medication

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FDA Regulations for Hearing Instrument Specialists

FDA Guidelines for Medication Guide Distribution

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FDA Guidelines for Drug Development & Approval

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FDA Decisions for IDE Clinical Investigations

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FDA Decisions for Investigational Device Exemption ... · FDA Decisions for Investigational . Device Exemption Clinical Investigations Guidance for Sponsors, Clinical Investigators,

FDA Approval for Oncology Drugs

Management Responsibility for FDA Quality Systems

TAC for FDA System