COURSE OVERVIEW

This 2-day course, taught by PathWise, MasterControl and former FDA investigators, is designed to meet the requirements mandated by regulatory agencies to effectively investigate and locate causes and correct them. Attendees learn proper identification of non-conformances (problems), how to assess and prioritize them based on risk, and how to implement a proper corrective and/or preventive action.

Our CAPA course teaches the following key process skills:

• Issue Review - Identify and prioritize non-conformances based on risk.
• Root Cause Analysis - Investigate systemic issues for underlying cause.
• Implementation & Effectiveness Checking - Solution selection, verify and validate, implement, monitor and confirm success.

LEARNING OBJECTIVES

Throughout the workshop, attendees improve their ability to:

• Gather relevant information on problems through specific, focused questioning.
• Pinpoint root causes using facts instead of guesswork or opinion.
• Avoid costly experiments and trial fixes by logically testing possible causes.
• Assess and prioritize each nonconformance based on risk
• Target potential problems before they happen and develop actions to prevent them.
• Check effectiveness of corrective actions.
• Document the analysis in an easy-to-use format.

AUDIENCE

CAPA is appropriate for individuals who are regularly called upon to resolve problems, or whose input would aid in preventing problems. Examples include investigators, laboratory, QA/RA functions, managers, manufacturing supervisors, technicians, and engineers.

This course will not only focus on CAPA, but on how to conduct investigations including non-conformances, customer complaints, out of specifications, or any other investigations you may face within your organization.

SPEAKERS

Nathan Conover
Sr. Partner
PathWise

Ken Peterson
Quality Architect
MasterControl

Dannie Rowland
Former Investigator
Food and Drug Administration

DATES

August 4-5, 2010

LOCATION

Tokyo, Japan

COST

$1995 USD (=179,107.10 JPY)  - Includes Breakfast, Lunch & Materials

AGENDA

Day One

8:30 a.m. - Registration & Breakfast
9:00 a.m. - Opening Remarks
9:30 a.m. - Issue Review
12:30 p.m. - Lunch
1:30 p.m. - Root Cause Analysis
4:30 p.m. - Q&A Discussion
5:00 p.m. - End of Day One

Day Two

8:30 a.m. - Breakfast
9:00 a.m. - CAPA Implementation
12:00 p.m. - Lunch
1:00 p.m. - Effectiveness Checking
3:00 p.m. - Regulatory Body General Session
4:00 p.m. - Regulatory Body Panel Discussion
4:30 p.m. - Q&A Discussion