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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
***Specially Priced Articles***
Good Laboratory Practice Regulations vs. Good Manufacturing Practice Regulations: A Review of Their Intended Purposes and Requirements (click here to view article excerpt)
➢Purchase this individual article in the enKap store (NOTE: Special Pricing $29.95)
➢Subscribe to the FDA Compliance Digest for one year - 6 issues only $199.00
Note: Page under construction. Articles added periodically
Read more about the FDA Compliance Digest...
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➢Current Issue: Table of Content and Article Excerpts (click here)
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GLP LIVE Training Workshops - (click here for complete brochure)
Two GLP Workshops in Two Locations
1. The Brass Tacks of GLP: Practical Understanding of the Fundamentals As Never Before Explained
2. Writing Effective GLP Docments
March 9-10, 2010 San Diego
March 11-12, 2010 San Francisco by a GLP Subject Matter Expert
Medical Device Software Validation LIVE Training Workshops - (click here for complete brochure)
Two Workshops in Two Locations
1. Medical Device Software Validation: System Definition and Requirements: Incorporating Effectiveness and Compliance in Software Design
2. Implementing Critical Processes for Effectively Supporting Medical Device Software Validation Programs
March 24-25, 2010 Iselin, NJ
May 19-20, 2010 Waltham, MA by Boston Scientific
CAPA LIVE Training Workshops - (click here for complete brochure)
Two Workshops
1. CAPA: Effective System Management - One Industry Professional Shares His Expertise
2.Supplier-Related CAPA: Conducting Effective Root Cause Investigations
April 20-21, 2010 Boston/Waltham, MA
by a CAPA Subject Matter Expert
GMP LIVE Training Workshop: Master Production Batch Records - (click here for complete brochure)
Effective Generation and Control of Master Production Batch Records (MPBR)
April 22, 2010 Boston/Waltham, MA by a GMP Subject Matter Expert
May 12-13, 2010 Hilton Woodbridge-Iselin, NJ by a GMP Subject Matter Expert
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