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Resources

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Get 21 CFR Regulations in eBook Format!

Throw out your old paper-based GMP regulation books and bring compliance into the 21st Century!

Compliance Architects® has taken many of our favorite FDA regulations and put them into eBook format – which makes them incredibly usable on your smartphone!  Our free, eBook regulations are available here in ePub format, designed specifically for use in eBook readers on both Apple and Android smartphones. eBooks provide a greatly improved user interface for reading, referencing, and working with FDA regulations. Here’s what you can do with eBooks that you can’t do with paper regulations:  Search;  Annotate;  Bookmark;  Highlight;  Share;  and much more!  Don’t rely on tired, outdated paper pocket guides to look up regulatory information – use the free Compliance Architects® eBook regulations and never forget what is in the regulations again!

Quality, Compliance & Regulatory Resources

Compliance Architects® has, and will continue to develop, a variety of different resources that we hope will be helpful and of interest to Quality, Compliance and Regulatory professionals within FDA-regulated industry. Available resources will include Free Online Training; Regulation eBooks; Presentations and White Papers; Success Stories; Videos and Webinars.

Please check back regularly for updates to our resources page, or, subscribe to our Resources email updates!

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6 Reasons to Work with an Interim Expert/Executive Placement Firm — Amazing How Executives Don’t Recognize the Risks in No. 4

1.  The Opportunity Cost of Swapping Staff from One Project to Another: The need to constantly swap internal resources to

21 CFR 117

21 CFR 117 - CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD
Case Study

Managed Service Solution for Pharmaceutical Annual Product Review (APR)

This case study explores in detail a significant client engagement whereby Compliance Architects® dramatically improved Annual Product Review outcomes for one
White Paper

LIVE REVIEW: Managing The New Approach to FDA Inspections of Quality System Documentation

Today, FDA Investigators don't just pore over your documents, they access your computer-based systems to obtain your information directly!  The
White Paper

Quality Management in the Third-Party Supply Chain

This White Paper provides an in-depth review of contemporary capabilities and solutions for effectively integrating third-party CMOs and other suppliers with
One Pager

Quality Capability Maturity Model

This one page diagram shows Compliance Architects® take on a Quality Capability Maturity Model for life science regulated manufacturers.  Considering
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Federalized Planning Organizational Model

Many large enterprises struggle with the tension between market-focused business units, and the leverage, harmonization and cost-effectiveness that comes from
One Pager

Four Quadrant Corporate Compliance Framework

This simple graphical framework provides a practical visualization of how to successfully implement the US Department of Justice "Seven Elements"
White Paper

White Paper: Quality System Design for Cosmetic Manufacturing

FDA's June 2013 Guidance for Industry, Cosmetic Good Manufacturing Practices, has outlined FDA's thinking and expectations surrounding the quality and control approaches
Presentation

Dietary Ingredient Regulatory Analysis Flowchart

This document provides an easy to use and interact with flowchart to determine whether or not a potential ingredient for
eBook

21 CFR Part 820

Quality System Regulation Title 21 - Food and Drugs, Volume 8 Chapter I - Food and Drugs Administration Department of
eBook

21 CFR Part 806

Medical Devices; Reports of Corrections and Removals Title 21 - Food and Drugs, Volume 8 Chapter I - Food and
eBook

21 CFR Part 610

General Biological Products Standards Title 21 - Food and Drugs, Volume 7 Chapter I - Food and Drugs Administration Department
eBook

21 CFR Part 111

Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling or Holding Human Operations For Dietary Supplements Title 21 - Food and Drugs, Volume 2
eBook

21 CFR Part 110

Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food Title 21 - Food and Drugs, Volume 2 Chapter I
eBook

21 CFR Part 107

Infant Formula Title 21 - Food and Drugs, Volume 2 Chapter I - Food and Drugs Administration Department of Health and
eBook

21 CFR Part 106

Infant Formula Requirements Pertaining To Current Good Manufacturing Practice, Quality, Control Procedures, Quality Factors, Records and Reports, and Notifications Title
eBook

21 CFR Part 50

Protection of Human Subjects Title 21 - Food and Drugs, Volume 1 Chapter I - Food and Drugs Administration Department of
eBook

21 CFR Part 58

Good Laboratory Practice For Nonclinical Laboratory Studies Title 21 - Food and Drugs, Volume 1 Chapter I - Food and Drugs
eBook

21 CFR Part 211

Current Good Manufacturing Practice For Finished Pharmaceuticals Title 21 - Food and Drugs, Volume 4 Chapter I - Food and Drugs
eBook

21 CFR Part 11

Electronic Records; Electronic Signatures Title 21 - Food and Drugs, Volume 1 Chapter I - Food and Drugs Administration Department
eBook

21 CFR Part 56

Institutional Review Boards Title 21 - Food and Drugs, Volume 1 Chapter I - Food and Drugs Administration Department of Health

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