Registration 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.
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.
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. 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.
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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.
Fees and Registration
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