Sign up for EduQuest's Free
Monthly E-Newsletter:
EduQuest-ions & Answers
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.
You can
unsubscribe at any time.
Or
get answers immediately to
your FDA compliance
and quality system questions
from
EduQuest's Free
and Searchable
Q&A
ARCHIVES:
Click here to see previous issues of EduQuest-ions
& Answers
►►►This
Month's Featured FREE Compliance Advisory from
EduQuest:
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
Free and downloadable.
Click on any title to open the document. No
registration, no password required.
To save a document to your computer,
right-click and "Save As":
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
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
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
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
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
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
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
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:
Free and downloadable.
Click on any title to open the document. No
registration, no password required.
To save a document to your computer,
right-click and "Save As":
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.
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.
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.
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 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'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.
FDA
Medical Device Quality Systems Manual: A Small
Entity Compliance Guide
