 |
This
2½ day course provides intensive coverage of the elements
of a corrective and preventive action (CAPA) system.
Objective
After completing the course, participants
will understand the essentials of an effective CAPA system and understand
what is required for compliance with the Quality System regulation.
In addition, participants will come away from the course with the
ability to implement a closed loop continuous improvement system.
This course also includes a workshop on cause analysis and problem
prevention, core skills that assist in properly identifying and documenting non-compliances (problems), and taking the necessary preventive
action.
Who
Should Attend?
Instruction
is targeted to quality assurance personnel, regulatory affairs professionals,
implementers of an organization's CAPA system, and management involved
in review and oversight of the system. In 2006, FDA brought the course in-house to train Office of Compliance employees.
Format
This course relies on a highly interactive
format incorporating case studies and analysis of specific situations
taken from Warning Letters. Tools of industry "best practices"
are included to improve effectiveness for implementation.
Dates
and Hotels
| DATE |
LOCATION |
PHONE & RATES |
June 2-4, 2008
|
The Westin Arlington Gateway *
801 North Glebe Road
Arlington, VA 22203
Website |
888-627-7076
/ 703-717-6200
$199 single/double
rate through May 5, 2008 |
| NOTE: Reservation requests should be made as soon as possible, but no later than the" rate through" date listed above. Rooms are assigned on a first-come, first-served basis and may sell out prior to the deadline. |
| * Due to the number of events that AAMI is holding at the Westin Arlington Gateway in 2008, it is necessary to specify which course you are attending when making your room reservation. |
|
Faculty
Course
faculty are drawn from an experienced group of quality systems professionals.
All course faculty have completed an instructor training program
to ensure consistency and quality from session to session. The mix
of industry leaders, consultants, and FDA personnel helps to ensure
a balanced presentation of the requirements and paths to compliance.
Program
At-A-Glance
DAY
ONE
8:00
AM-5:00 PM |
KNOW WHAT TO DO |
— Introduction and Definitions
— Requirements for CAPA
— Analysis in the CAPA System
— Investigations
in the CAPA System
— Documentation, Records, and Tools |
DAY
TWO
8:00
AM-5:00 PM |
HOW TO DO IT |
— Cause Analysis: Investigating Causes and Solving Problems
— Problem Prevention: Ensuring Successful Implementation
— Simulations and Case Studies |
DAY
THREE
8:00
AM-12:00 PM |
EVALUATE THE SYSTEM |
— CAPA System from an FDA Perspective
— Effectiveness Checks and Timeliness
— Management Oversight and Review |
|
Materials
Participants will receive The Quality System
Compendium, 2ed. (the textbook from AAMI's comprehensive course, Quality System
Requirements and Industry Practice); materials from PathWise,
Inc. on cause analysis and problem prevention; pertinent FDA documents;
additional references; and a participant's guide for easy note-taking.
Registration
Fees
Fee
includes course materials; continental breakfast and refreshment
breaks for three days; and lunch for first two days of the course.
| REGISTRATION
TYPE |
2008
FEES |
| AAMI
Corporate & Institutional Member |
$1685 |
| AAMI
Individual Member |
$1785 |
| Nonmember |
$2085 |
| Government
Employee |
$585 |
|
Join
AAMI and Save!!
Link
to Membership
| MEMBERSHIP
TYPE |
2008
FEES |
| U.S.
Individual Membership Rate |
$200 |
| Non-U.S.
Individual Membership Rate |
$260 |
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