Corrective and Preventive Action Requirements and Industry Practice
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); taking the proper corrective action or identifying potential 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 |
Check back for 2010 schedule.
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| 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. |
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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 |
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Fees and Registration
Fees include the textbook,
The Quality System Compendium, 2nd ed.; participant notebook of course materials and case studies; relevant standards and technical information reports; pertinent FDA documents and additional references; and continental breakfast, lunch, and refreshments.
| REGISTRATION
TYPE |
2009
FEES |
| AAMI
Corporate & Institutional Members |
$1685 |
| AAMI
Individual Members |
$1785 |
| Nonmembers |
$2085 |
| Government
Employees |
$585 |
|
Join
AAMI and Save!! Link
to Membership
| MEMBERSHIP
TYPE |
2009
FEES |
| U.S. Individual Membership Rates |
$205 |
| Non-U.S. Individual Membership Rates |
$265 |
|
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