Engaged. Knowledge. Application
FDA Compliance Digest - November 2009 Table of Contents
***CLICK ON ARTICLE TITLE TO VIEW EXCERPT***
➢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
***Special Note: Related SOP Training and Auditing Templates, Checklist, PowerPoint and more will be published in the January 2010 issue.
➢General Informed Consent Checklist
➢LIMS Validation Projects: Critical Considerations for Successful Execution
➢Regulatory Documents Explained: The Basics
➢Quality Agreements: Regulatory Considerations for Development and Implementation
➢Active Pharmaceutical Ingrediant (API) Product Quality Agreement Template
➢Quality Agreement PowerPoint Training Presentation and Trainer Instructional Notes
➢Electronic Signatures and Electronic Records: Frequently Asked Questions and Answers
➢Interested in Writing? Click Here for Author's Guidelines
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***CLICK HERE to view the FDA Compliance DIgest SAMPLE ISSUE***
➢Current Issue: Table of Content and Article Excerpts (click here)
➢Individual Articles (click here)
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