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Current
Courses:
2012 Schedule of EduQuest Training Classes 
Six classroom courses taught by former FDA
inspectors, policy-makers,
and senior executives from regulated
industry
If you're preparing for an FDA or
internal audit; need expert advice on FDA's expectations for computerized
system validation, or confused about Part 11 and the EU's new Annex 11,
sign-up for:
FDA Auditing of Computerized
Systems and Part 11/Annex 11
March 26-28, 2012 -
Clarksburg, Maryland (near Washington, DC)
 
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If you need to upgrade your company's
quality system, reduce non-conformances, or respond to an FDA 483 or
Warning Letter about quality problems, sign-up for:
The CAPA Confidence Clinic:
Effective CAPA Systems
and Failure Investigations
March 29-30, 2012 - Clarksburg, Maryland
(near Washington, DC)
June 14-15, 2012 - Rosemont (Chicago), Illinois --
in cooperation with OMTEC 2012
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If you need to meet U.S. and
international standards for risk management and learn to use
FDA-recognized tools for risk assessment and mitigation, sign-up for:
Quality Risk Management for
FDA/ICH Q9 Compliance
March 29-30, 2012 - Clarksburg, Maryland
(near Washington, DC)
_____________________________
If you need to develop a by-the-book
quality management program for medical device production, sign-up for:
QSR Compliance Basics (21 CFR 820)
April 17-18, 2012 - Clarksburg, MD (near
Washington, DC)
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If you need to learn FDA's rules for
medical device quality design, design transfer, and manufacturing,
sign-up for:
Design Control for Medical Devices
(21 CFR
820.30)
April 18-20, 2012 - Clarksburg, MD (near
Washington, DC)
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If you need to better manage the
quality performance and conformance of your medical device suppliers and
contract manufacturers, sign-up for:
Managing and Auditing
Suppliers/Contract Manufacturers
June 14-15, 2012 - Rosemont (Chicago), Illinois --
in cooperation with OMTEC 2012
To register for any course, click on Sign-Up Form
links
or call EduQuest:
+1 (301) 874-6031
Monday through Friday, between 9 a.m. - 5 p.m.
Eastern U.S. time.
On-Site Training
Available When and Where You Want
EduQuest courses can
be delivered directly at your facility -- when and where convenient for you and your staff.
On-site, on-demand training usually is cost-effective if you have 10 or
more who need the training. Contact
us for details and pricing.
To be notified when
additional public course dates and locations are confirmed,
Sign
up for our monthly Q&A Newsletter here or Send
us an Email
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The FDA Compliance Bootcamp
Course Series
March 26-30, 2012
Clarksburg, Maryland
A
three-day class followed by your choice of either a 12-hour class on
effective CAPA systems or a 12-hour class on FDA's expectations for
risk management. Attend all five consecutive days of training or
select the course(s) you need most.
Training
is designed for pharmaceutical, biologics, and medical device
manufacturers, laboratories and research sites.
The FDA
Compliance Bootcamp consists of the courses below (select either The
CAPA Clinic and Quality Risk Management, which are held
concurrently).
Click
on course titles for agenda and details:
FDA
Auditing of
Computerized Systems
and Part 11 / Annex 11:
EduQuest's
Flagship Training Class for More than 15 Years. Taught by the same instructors
who taught FDA and Health Canada field investigators and managers how
to inspect and interpret rules for computerized system validation and
21 CFR Part 11.
March
26-28, 2012 - Clarksburg, MD
(Monday through Wednesday)
The CAPA
Confidence Clinic:
FDA Rules for Effective CAPA Systems
and Failure Investigations
March 29-30, 2012 -
Clarksburg, MD
(Thursday through Friday
morning)
NEW
OFFERING JUST ADDED:
June
14-15, 2012 - Rosemont (Chicago), IL
Quality
Risk Management
for FDA/ICH Q9 Compliance:
Agency Expectations * Global Standards * Tools for Success
March
29-30, 2012 - Clarksburg, MD
(Thursday
through Friday morning)
Click here to
Download/Print Registration Form for March 2012 Clarksburg, MD
Courses
Click here to
Download/Print Registration Form for June 2012
Rosemont (Chicago), IL Courses
Click here to
See Instructor Qualifications
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The Medical Device Quality &
Compliance Institute
April 17-20, 2012
Clarksburg, Maryland
A
12-hour introductory class on FDA's QSR/device GMP rules followed by an
optional, in-depth 16-hour class on FDA's rules and expectations for
design controls. Attend one or both courses to ensure you understand
what FDA will be looking for during your next site inspection.
Training
is designed for medical device and diagnostic product manufacturers,
suppliers and R&D facilities.
The Medical
Device Compliance Institute consists of the two courses below.
Click
on course titles for agenda and details:
QSR Compliance
Basics:
Complying
with FDA's Medical Device 21 CFR 820 Quality Systems Regulation
April
17-18, 2012 - Clarksburg, MD
(Tuesday
through
Wednesday
morning)
Design Control for Medical Devices:
Meeting
FDA's 21 CFR 820.30 Rules for Quality Design and Manufacturing
April
18-20, 2012 - Clarksburg MD
(Wednesday
afternoon
through
Friday morning)
Click here to
Download/Print Registration Form for April 2012 Clarksburg, MD
Courses
Click
here to
See Instructor Qualifications
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