Engaged. Knowledge. Application
FDA Compliance Digest - January 2010 Table of Contents
***CLICK ON ARTICLE TITLE TO VIEW EXCERPT - Note: Not all articles have excerpts***
➢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
➢SOP Training and Auditing Templates: SOP on SOPs for Good Manufacturing Practice
➢Preparation, Content, Administration and Review (PCAR) of Standard Operating Procedures
➢SOP Template
➢SOP Functional Unit Designations
➢SOP Request Form
➢SOP Checklist
➢SOP on SOPs PowerPoint Presentation
➢Conclusion
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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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