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Live eLearning ‐ PDA 576.2 Root Cause Investigation for CAPA

Jul 22, 2020
8:00 AM
-
5:00 PM
| Eastern Standard Time
Online
  • Virtual
  • Education
  • Online

Overview

Root Cause Investigation for CAPA is a globally renown methodology for investigating technical performance challenges. Problem solving techniques from Six Sigma, 8D, Kaizen, DMAIC, TQM and others are leveraged to identify:

  • Technical root causes: the change(s) that occurred resulting in performance decline
  • Systemic root causes: failures that allowed the change(s) to occur
  • Corrective and preventive actions: restore performance to previous levels or requirements
  • Control plan: monitor and prevent recurrence

This training is designed to engage the participants the entire time. In addition to the instructor case study, lecture, polls, quizzes, and conversations, participants will apply the methodology during the training on a real-life case study. Participants are provided a training manual, an Investigation Roadmap, and a set of electronic templates that guide them through the methodology, recommend tools, and establish the basis for documentation.

For more options and/or related training courses, please visit the page(s) below.

PDA Quality Assurance Training Courses

Trainers

Rob Weaver
Rob Weaver
Weaver Consulting

Learning Objectives

  1. Apply a 7-step investigation methodology to determine the root cause of a technical problem
  2. Identify the technical root cause (the change) and any systemic root causes
  3. Implement effective corrective/preventive actions
  4. Develop and implement a control plan to prevent issues from reoccurring

Who Should Attend

This training course is intended for professionals who conduct or participate in root cause investigations for all medical devices and pharmaceuticals.

Departments
  • Quality Control
  • Engineering
  • Manufacturing
  • Quality Assurance Operations
  • Supply Chain
  • Facilities

Roles
  • Specialist
  • Analyst
  • Supervisor
  • Manager

Registration Fees

Register Now
Registration Type Price
Member $700
Non-member $700
Gov't/Health Auth./Academic $700

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