CAPA for Life Sciences

CAPA for Life Sciences - Boston

Last year alone, nearly 200 Warning Letters were issued to medical device and pharmaceutical firms for QS/GMP deficiencies, with CAPA being the most prevelant subsystem noted.

Our CAPA training course is designed to meet the requirements mandated by world regulatory bodies to effectively investigate and locate causes and correct them. We show you how to properly identify non-conformances (problems), how to assess and prioritize them based on risk, and how to implement a proper corrective and/or preventive action.

COURSE OVERVIEW

This two-day workshop, taught by PathWise and MasterControl quality training instructors, is broken down into the following quality modules:

Event Management
Risk Assessment
Root Cause Analysis
Implementation & Effectiveness Checking

At the end of this course, participants will be able to:

Minimize repeat investigations.
Reduce length and number of investigations.
Identify true root causes.
Lower overall costs associated with quality events.
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 Event based on risk.
Target potential problems before they happen and develop actions to prevent them.
Check effectiveness of corrective actions in the CAPA system.
Ensure proper documentation of the CAPA report.

AUDIENCE

Our CAPA workshop 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.

The course is taught using a blended approach of classroom and real-life application. This "how-to" approach significantly increases knowledge retention and allows participants to apply the skills as they learn in a dynamic setting.