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QSR
Fundamentals
Complying with FDA's Medical Device
21 CFR 820 quality Systems Regulations
1 day course (8:30 a.m. - 5:30 p.m.)
Quality Systems Training Direct from
Former FDA Device Officials
Learn straight from the source
– former FDA inspectors, rulemakers, and trainers
from the global consulting team of
EduQuest
- September 20, 2010, Wilmington, DE
The
scope of FDA's Quality Systems Regulation (QSR) is huge - more than 500
pages of
rules
and guidance - and non-compliance is not an option. Just within the
past 12 months,
27
medical device companies received Warning Letters for deficient quality
management
programs,
and several were threatened with removal of their products from the
market.
Full-Day QSR Course Provides Compliance Foundation
Compliance
with FDA's Quality Systems approach is recognized globally as a
prerequisite
not only for getting your product on the market but - just as importantly
-
keeping
it there.
The full-day QSR Fundamentals course walks you through the
requirements of 21 CFR
820,
discusses how FDA's rules correlate with ISO standards and ICH guidance,
and
examines current FDA inspection and enforcement priorities.
Why You Should Attend:
- Fully
understand your company's obligations under 21 CFR 820
- Your
instructors are former FDA medical device investigators, including
the
former editor and co-author of the FDA's "bible" for
inspectors, the
Investigations Operation Manual (IOM), as well as experts
from the regulated
community
- Here
"lessons learned" by other device companies who have been
cited by FDA
for deficient quality management
- See
how FDA rules related to ISO and ICH standards - save time and money
with and integrated compliance blueprint
- Learn
to quickly capture feedback - both internal and external - to
fine-tune your
quality system and avoid product seizures and recalls
- Compare
notes with other device manufacturers who face challenges similar to
yours
- Receive
EduQuest's QSR Compliance Resource CD with electronic copies
of
FDA's latest quality regulations and guidance
- Receive
a Certificate of completion to document your training to senior
management and FDA inspectors
Can’t make these dates?
Subscribe to free EduQuest-ions & Answers Compliance
Newsletter
to learn
when new dates and locations are scheduled.
Course
Content:
·
FDA's Evolving
Approach to Quality Systems
o
Scientific
foundations of quality systems
o
Key quality
system elements according to ISO and FDA
o
Speaking the
lingo: important cGMP terms and definitions
·
Introduction
to FDA's Quality Rules for Medical Devices
o
Core
principles
o
Quality and
compliance: two sides of the same coin
o
Seven
FDA-recognized subsystems of your quality system
·
ISO/ICH
Approaches to Quality Systems
o
Comparison of
international standards to FDA expectations
o
ISO 9001: 2000
quality system requirements
o
Relationship
to ISO 13485: 2003
·
QSR Management
Review and Control (Subpart B)
o
Management and
executive responsibilities
o
Developing a
Quality Policy
o
Allocating
adequate resources
·
QSR
Design Control/System Development (Subpart C)
o
Tools for
design control
o
Research vs.
design
o
Design
verification and validations
·
QSR
Production and Process Controls (Subparts G, O)
o
Tools for
controlling and monitoring processes
o
Process
validation
o
Computerized
system validation, including validating off-the-shelf software
·
QSR
Corrective and Preventive Actions - CAPA (Subparts J, I, N)
o
Difference between
correction vs. corrective action
o
Examples of
preventive action
o
Evaluating
CAPA sources
·
The
Yin/Yang of Design/CAPA
o
FDA’s trending
requirement
o
ISO 9001:2000
trending requirement
·
Laboratory
Controls for combination products (21 CFR Part 211 Subpart I)
o
Process tasks
for laboratory controls
o
Documenting
laboratory operations
o
Validating
laboratory test methods
·
Conducting
Failure Investigations
o
Importance of
identifying root cause
o
Seven basic
investigation tools your should know
o
Best practices
for reducing failures
·
QSR Documents,
Records and Change control (Subparts D, M)
o
Assuring
changes are reviewed and approved
o
Tools for
change control
·
QSR Facility
and Equipment Controls (Portions of Subpart G)
o
Minimizing
adverse impacts of manufacturing environment
o
Tools for
facility and equipment control
o
Key
environment controls
·
QSR Material
Controls (Subparts E, F, H, K, L)
o
Evaluating
suppliers, contractors and consultants
o
Tools for
material controls
·
How to
Prepare for an FDA QSR Inspection
o
Understanding
FDA’s Quality System Inspection Technique (QSIT)
o
Quality system
objective evidence the inspector will want to see
o
Examples of
systems-based questions to use to prepare
·
FDA
Enforcement Priorities
o
Understanding
FDA’s mindset
o
Inspection
Observations and Reports
o
Consequences of non-compliance
o
Recent trends in FDA 483 observations
o
Practical suggestions surviving an
inspection
To Register or Get More Details:
Email Cece Bland, Director of Training
and Information Services,
at Info@EduQuest.net or call +1 (301) 874-6031. Tuition is $990.
Three-Day Device
Compliance Learning Package:
Save by
Attending Back-to-Back Courses
Immediately before this Design Control
course, EduQuest will offer at each location a
two-day course on Design Control for Medical
Devices: Meeting FDA's Medical 21 CFR.30
Rules for Quality Design and Manufacturing.
Save $175 when you attend both courses. The combined tuition is just $2795,
including
three full days of hands-on-training,
all course materials, lunch, refreshments, and the
opportunity to learn and interact with
some of the top FDA compliance experts in the nation.
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