An EduQuest Advisory is a brief but comprehensive white paper that provides practical FDA compliance advice from EduQuest’s expert staff.
Click on the links below to access each EduQuest Advisory directly through Amazon.com’s Kindle Store:
Both Advisories are written by Denise Dion, EduQuest’s Vice President of Regulatory and Quality Services. Denise spent 18 years with FDA’s Office of Regulatory Affairs as an investigator on both regional and national levels. She also was co-editor of FDA’s Investigations Operations Manual (IOM) and a developer and trainer of FDA’s Quality Systems Inspection Technique (QSIT).
About the FDA Playbook EduQuest Advisory
Every year, the U.S. FDA updates the Investigations Operations Manual for its network of inspectors and field investigators. FDA makes this incredibly useful collection of agency policies, guidelines and checklists readily available to anyone, including companies subject to scheduled and unannounced visits by FDA.
The EduQuest Advisory, “Using FDA’s Own Playbook to Prepare for Your Next Audit”, helps you use FDA’s 2011 IOM edition to assess your facility’s inspection readiness. It also guides you to the sections and subsections of the 480-page manual that will help you develop SOPs that anticipate and complement FDA’s inspection process.
With the Advisory, you’ll better understand what FDA inspectors will look for, select the most relevant IOM inspection protocols, and integrate them into your own internal audit programs.
About the Validation EduQuest Advisory
The EduQuest Advisory, “Verification vs. Validation”, explains the terms and processes from the perspective of a former senior FDA investigator.
Since joining EduQuest, Denise has spent the past nine years looking at V&V from industry’s side, walking manufacturing floors, auditing product design labs, reviewing CAPA programs, and helping device makers understand the critical difference between verification and validation.
The Advisory is designed to help you identify the most important regulatory expectations and clarify the gray areas that distinguish V&V either in reality or perception. Direct citations from regulations and guidance documents are included.
Also Available in the U.K., Germany and France
These EduQuest Advisories also are available in the U.K., German and French Kindle Stores, with pricing in Pounds and Euros that includes VAT and free wireless delivery via Amazon’s Whispernet network.
Visit www.Amazon.com and use the search term EDUQUEST to identify the latest updates and additions.