Improving quality and compliance in the life science industry

Corrective Action / Preventive Action Training

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.

Medical Device, Pharmaceutical & Biotech Consulting Firm

LEARNING OBJECTIVES

Our clients improve their ability 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

CAPA is a two-day course 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. We also have a one day course specifically designed for Root Cause Analysis.

PathWise not only provides an outside perspective to these issues, we bring proven best-practices, tools, and processes. We’ve studied the best of the best in the life sciences field, and bring an intimate knowledge of regulations.

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FREE DOWNLOAD

Learn how to avoid repeat CAPA investigations in the white paper below.

Medical Device, Pharmaceutical & Biotech Consulting Firm

FDA, CAPA & Regulatory Compliance Training

Through training in PathWise Project Success managers learned a process for the selection and approval of projects. Team leaders and team members acquired the skills to accomplish projects on time and within scope.

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