FDA Compliance Resource Library from EduQuest

 

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for better Quality Systems, Validation Projects, 

Internal Audits, Design Controls, and FDA Inspection Preparedness

 

 

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EduQuest-ions & Answers is delivered to you every month via email. You'll receive timely and practical, real-world FDA compliance advice based on Frequently Asked Questions we receive from our clients, course alumni, and fellow FDA compliance professionals. In addition, you'll receive announcements when new or updated EduQuest compliance Advisories -- such as the ones below -- are released.

 

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►►►This Month's Featured FREE Compliance Advisory from EduQuest:

 

Correlation (Cross-Walk) between 21 CFR 820

and Best Practices in Design Controls

 

Download this free 76-page EduQuest Advisory for a detailed "cross-walk" connecting your requirements under FDA's 21 CFR Part 820 (the Quality System Regulation) to the best practices in Design Controls -- as recommended by EduQuest Vice President Denise Dion. Denise served 18 years as an expert FDA field investigator and was a member of FDA's Design Control Inspection Strategy Team.

 

 

With an easy-to-read matrix format, the Advisory links each Part and Subpart of the QSR to its impact on your Design Control activities. You'll see that FDA's expectations for Design Controls go well beyond those you find in Subpart C (21 CFR 820.30) -- usually considered the Design Control portion of the regulation.

 

Denise Dion also is the developer and lead instructor of EduQuest's popular two-day Design Control for Medical Devices training class, scheduled April 5-6, 2017, near Baltimore and Washington, DC. In addition to explaining FDA's Design Control rules in every-day language, the class allows you to be part of a fictional product design team and identify Essential Design Inputs and Outputs; validate and verify product design; efficiently handle Design Changes; and effectively transfer product design to the manufacturing floor and your suppliers. Click here for details on the Design Control for Medical Devices training class.

 


More EduQuest Compliance Advisories:

 

Practical Advice from EduQuest's Global Staff of FDA Compliance Experts

 

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How to Respond to FDA Inspection Observations, Including Those You Dispute

This Advisory, first published in January 2016 in MasterControl's GxP Lifeline Newsletter, is written by EduQuest's President, Martin Browning, who served as an expert field investigator at the FDA for more than 20 years. He provides a glimpse into FDA's post-inspection process and explains why it's important to address and resolve 483 observations before the inspector leaves your facility, or very soon thereafter. He explains exactly what you should include in your written 483 response and offers examples of effective responses compared to inadequate ones. MORE

 

Need training on this subject?

Attend EduQuest's FDA Auditing of Computerized Systems and Part 11/Annex training class

 

Annex 11: The EU's New Expectations for Regulated Computerized Systems

In 2011, the European Union (EU) revised its guidance for the life cycle of computerized systems to reflect the increased use and complexity of automated systems in the pharmaceutical industry. The guidance, called Annex 11, also was revised in response to an alarming number of problems detected in computerized systems. MORE

 

Need training on this subject?

Attend EduQuest's FDA Auditing of Computerized Systems and Part 11/Annex training class

 

Side-by-Side Comparison of FDA's Part 11 and the EU's Annex 11

The relationship between FDA’s Part 11 (21 CFR Part 11) and the European Union’s Annex 11 (EUDRALEX

Rules Governing Medicinal Products in the European Union, Volume 4, Good Manufacturing Practice,

Medicinal Products for Human and Veterinary Use) diverges in philosophy. Both documents cover the

same topic, the use of computerized systems in regulated activities. However.. MORE

 

Need training on this subject?

Attend EduQuest's FDA Auditing of Computerized Systems and Part 11/Annex training class

 

The Four Pillars of QSR Compliance:

Build Your Subsystems, Strengthen Them with Data Links

At first glance, FDA’s Quality System Regulations (QSR) for medical devices – contained in 21 CFR 820 – may make your eyes cross and your stomach churn. The rules are intimidating, yes – but impossible to follow, no. Focus on four key quality subsystems – and connect and strengthen those subsystems with relevant data – and you’ll go far in meeting FDA’s expectations for quality products, processes and systems. And not so incidentally, mastering those key subsystems also will keep your ISO auditors happy, thanks to FDA’s efforts to harmonize its regulations with international standards. MORE

 

Need training on this subject?

Attend EduQuest's QSR Compliance Basics training class

 

Understanding Objective Evidence: What It Is and What It Definitely Is Not

As you likely know, computer system validation requires objective evidence -- evidence that proves the results of a particular system will be consistent throughout its operating lifetime. But do you really understand what constitutes objective evidence -- from a scientific and a legal perspective -- and of great importance to those subject to regulatory inspections -- from the perspective of the FDA? Let’s answer the question by first understanding what objective evidence is not. MORE

 

Need training on this subject?

Attend EduQuest's FDA Auditing of Computerized Systems and Part 11/Annex training class

 

The 9 Most Common Validation Errors:

Identify Frequent Deficiencies to Accelerate Your Validation Projects

What validation problems are you likely to see over and over? When tackling complex validation challenges, you’ll save time, money and headaches when you know the most common problems and where to find them. The following analysis is based on validation work EduQuest performed for a large FDA-regulated company over the past year. The goal was to bring the company’s software validation evidence up to the level of the U.S. FDA’s current expectations as well as those of the client’s own independent auditor. MORE

 

Need training on this subject?

Attend EduQuest's FDA Auditing of Computerized Systems and Part 11/Annex training class

 

The Hot Potato of Responsibility: How to Manage Outsourcing and Not Get Burned

Everything can be outsourced -- except responsibility. That's a rule the U.S. FDA lives by, and one you should embed in your policies, SOPs, and corporate culture. FDA holds corporate management, not the quality assurance department, responsible when outsourcing decisions go bad. MORE

 

Need training on this subject?

Attend EduQuest's Managing and Auditing Supplier Quality training class

 

Medical Device Concessions: Free Pass or Red Flag for Your Quality System?

Under regulatory guidance not well understood within the industry, the U.S. FDA allows medical device manufacturers to release "nonconforming products" using what’s known as a concession. The danger is that some manufacturers tend to rely on concessions as fall-back remedies when they lose control of their processes and produce out-of-spec products. Instead of immediately identifying and correcting quality problems at their source -- which is what the FDA expects -- these manufacturers are quick to claim a concession and then move on with business-as-usual, hoping the problems are not serious and will eventually correct themselves. MORE

 

Need training on this subject?

Attend EduQuest's QSR Compliance Basics training class

 


 

Compliance Guidance from the U.S. FDA

 

Prepare for your next inspection with these resources:

 

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2016 FDA Inspections Operations Manual (IOM)

The primary source of FDA policy and procedures for field investigators and inspectors. Considered "the bible" for FDA inspections. Updated annually by FDA; this is the complete 2016 version with all individual chapters and exhibits combined into one integrated PDF document. 523 pages. For additional information on how to use this resource to assess your inspection readiness, purchase the EduQuest Advisory "Using FDA's Own Playbook to Prepare for Your Next Audit" from the Amazon Kindle Store.

 

FDA Inspection of Medical Device Manufacturers Cover PageFDA Inspection of Medical Device Manufacturers

Guidance document representing FDA's current thinking on the enforcement of the Quality System (QS), Medical Device Reporting (MDR), Medical Device Tracking, Corrections and Removals, and the Registration and Listing Requirements. Document 7382.845 of the FDA Compliance Program Guidance Manual. Implementation date of February 2, 2011. 70 pages.

 

 

FDA Drug Manufacturing Inspections Cover Page

FDA Drug Manufacturing Inspections

Guidance to FDA inspectors for evaluating compliance with cGMP requirements. Document 7356.002 of the FDA Compliance Program Guidance Manual. Implementation date of February 1, 2002. 30 pages.

 

 

 

 

FDA Guide to Inspections of Quality Systems (QSIT) Cover Page

FDA Guide to Inspections of Quality Systems (QSIT)

Guidance to the FDA field staff on an inspectional process that may be used to assess a medical device manufacturer's compliance with the Quality System Regulation (QSR) and related regulations. The inspectional process is known as the Quality System Inspection Technique or QSIT. The process for performing subsystem inspections is based on a "top-down" approach to inspecting. Published August 1999. 108 pages.

 

 

FDA Medical Device Quality Systems Manual: A Small Entity Compliance Guide

FDA withdrew this Compliance Guide in December 2013 because it was not in step with the Agency's movement towards harmonizing its guidance to ISO and other international standards. Still, the Manual, which was published in 1999 and was designed as an aid to auditors and QA managers, provides educational materials, aids, and examples of procedures and control forms for implementing elements of a quality system. 373 pages.

 

 

FDA Development and Validation of Spreadsheets Cover PageFDA Development and Validation of Spreadsheets for Calculation of Data

FDA's internal guidance for the design and validation of in-house spreadsheets and other numerical calculation programs used in the Agency's laboratory operations. Volume III, Chapter 4.5 of the FDA ORA Laboratory Manual. Effective date of October 1, 2003, and revised January 13, 2013. Two pages.

 

 

 

 

Part 11 Preamble

The Preamble to Part 11 is invaluable for understanding the FDA's thinking behind promulgating the final regulation in March 1997. The Preamble responds to the  feedback the Agency received when the draft rule was first issued for public comment, and it also offers further details on the intent and scope of the regulation. It provides details on the Agency's policy towards electronic signature components and controls, biometrics, audit trails, linking electronic records to signatures, controls for closed systems, and more. 38 pages, including the text of the final Part 11 rule.

 


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