Root Cause Analysis (RCA) & Corrective and Preventive Action (CAPA)
WEBINAR
Date: Wednesday September 13, 2023 Time: 10AM ET to 11:30 ET with 10mins Q&A
Learning Objectives:
At the end of the webinar, attendees will be able to:
Explain why RCA and CAPA are critical to biopharm/device companies and their patients.
Identify simple tools for conducting root cause analysis.
Describe how to conduct RCA using Fishbone, 5 why’s, and 6M methodologies.
Design effective CAPAs to fix the problems identified by RCA.
Design effectiveness checks to determine if CAPA was effective or not.
The goal is to ensure all attendees walk away with practical best practices and foundational knowledge that they can bring back to their firms, whether as RCA/CAPA practitioners or approvers, or as change agents to help improve their deviation programs, find true root causes, and design effective CAPAs that reduce deviations.
Webinar Outline / Agenda
Welcome
The Deviation
Objectives and agenda
Overview and criticality of RCA & CAPA
Key definitions
RCA Tools
Purpose of investigation
5 why’s
6 M
Fishbone
Pitfalls to avoid
Designing Effective CAPAs
Goal of CAPA
CAPA planning
Effectiveness Checks
Summary/Q&A/Wrap-Up
Highlight key points from session
Q&A
Who Should Attend
This webinar will be valuable to all personnel involved in the deviation management process in any GXP environment, including Manufacturing, Quality, Supply Chain, and Facilities and Engineering employees. It will benefit individual contributors, subject matter experts, area managers, and QA personnel who author, coordinate, investigate, assess risk for, and/or approve deviations.
Speaker:
Matt Peplowski, M.S.
Matt Peplowski, M.S. is the founder, owner, and principal consultant at BioPharm Error Prevention Associates, Inc. (www.bepa-inc.com). He has over 30 years of GMP Manufacturing, Quality, and Learning & Development leadership experience at large and small, commercial and clinical biopharm companies. Matt has helped numerous companies as a leader or consultant by designing and delivering engaging, effective learning solutions, implementing targeted competency-based training frameworks, designing and implementing human error prevention strategies, and more. He is a subject matter expert in L&D, cGMP, Quality Systems, Human Error Prevention, GxP instructions writing, Investigations & CAPA, Data Integrity, and more. He can be reached at mpeplowski@bepa-inc.com and 978-502-9270.
