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Individual Articles: FDA Compliance Digest
Select individual articles are available for purchase that have been published in the FDA Compliance Digest.
Certain articles are not available for individual purchase.
CLICK ON ARTICLE TITLE TO VIEW EXCERPT - Note: Not all articles have excerpts
➢GMP Pharmaceutical Regulations: An Introduction to Interpretation and Enforcement
➢Understanding GMP Part 210: A Baseline Document for Interpreting Part 211 Regulations
➢Subpart C: Meeting GMP Requirements For Buildings and Facilities
➢Good Laboratory Practice Amendments and Deviations: Frequently Asked Questions and Answers
➢Drug Safety and Adverse Events for Clinical Trials: An Introduction
➢Standard Operating Procedures For GXP Operations: Practical Applications in FDA-Regulated Industry
➢GeneralInformed Consent Checklist
➢LIMS Validation Projects: Critical Considerations for Successful Execution
➢Regulatory Documents Explained: The Basics
➢Electronic Signatures and Electronic Records: Frequently Asked Questions and Answers
➢Meeting GMP Requirements: Subpart B - Organization and Personnel
➢Meeting GMP Requirements: Subpart B - PowerPoint Training Presentation
➢A Guide to Effective Management Practice-Part 1: CAPA Basics
➢CAPA Basics Article Q&A
➢CAPA Standard Operating Procedure (SOP)
➢Basic Principles of Complaint Handling
➢Managing the Complaint Handling Process: A Compliance Narrative from a Fictional Company
➢Good Documentation Practice Guide
➢Considerations in Writing More Effective Computer Validation Requirements
➢Ensuring Quality is Built Into Your Clinical Trial: A Comprehensive Plan - Part 1
➢Informed Consent Process: Effective Practices
➢GLP Regulations: A Guide for Executing an Effective Regulatory Compliance Program
➢Subscribe to the FDA Compliance Digest for one year - 6 issues only $199.00
Note: Page under construction. Articles added periodically
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***CLICK HERE to view the FDA Compliance DIgest SAMPLE ISSUE***
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➢Individual Articles (click here)
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