URGENT PANDEMIC INFORMATION

In light of the pandemic situation all of our 2021 events are cancelled. We will inform customers directly when the events are rescheduled.    
COVID CANCELLED: Project Management in Human Resources,   Boston MA, Jan 6-8, 2021
COVID CANCELLED: InterDrone, The International Drone Conference,   Cambridge MA, Jan 11-13, 2021
COVID CANCELLED: Supplier Management for Medical Device Manufacturers,   Cambridge MA, Feb 2-4, 2021
COVID CANCELLED: US Immigration Compliance Strategies,   Boston MA, Feb 15-18, 2021
COVID CANCELLED: Project Management Training,   Boston MA, Mar 3-5, 2021
COVID CANCELLED: Internal Audit, Fraud Risk Assessment Workshop,   Boston MA, Mar 22-25, 2021
COVID CANCELLED: Agile / Scrum Training,   Boston MA, Apr 12-14, 2021
COVID CANCELLED: Validation, Verification and Transfer of Analytical Methods,   Boston MA, Apr 19-21, 2021
COVID CANCELLED: Computer System Validation - Reduce Costs and Avoid 483s,   Boston MA, May 10-12, 2021
COVID CANCELLED: SharePoint Technology Conference,   Boston MA, May 26-28, 2021
COVID CANCELLED: Employment Laws Certificate Program,   Boston MA, Jun 7-9, 2021
Following events are tentatively planned but may be rescheduled, based on CDC guidelines or attendee registration interest .    
TENTATIVE: 21 CFR Part 11 Compliance,   Boston MA, Sep 22-24, 2021
TENTATIVE: Quality Control Laboratory Compliance,   Boston MA, Oct 6-8, 2021
TENTATIVE: Analytical Instrument Qualification and System Validation,   Boston MA, Nov 15-17, 2021
TENTATIVE: FDA's New Import Program for 2021,   Boston MA, Dec 7-9, 2021

Boston Professional Events List


Root Cause Analysis for CAPA Investigations A Systematic Approach Live


Date
Jun 08, 2021 - 01:30 PM - Jun 09, 01:30 PM
Organizer
WCS
Venue
online
Location
WCS Consulting Inc.3190 Stirling Rd, Unit K4 ,Hollywood, FL 33021,

Hollywood,
FL,
US,
ZIP: 33021
Phone: 844-267-7299 | 954-947-5671  

Overview
Problem solving is critical to successfully maintaining and improving pharmaceutical and biotech processes. Processes are dynamic and as predicted by the 2nd law of thermodynamics will deteriorate over time if left alone. Federal Regulation Title 21 requires that an organization’s quality system include a process for Corrective and Preventive Action. Central to an effective CAPA system is the identification of root causes of problems. Systematic approaches for problem solutions have been called for but few have appeared. Problem and deviation solutions tend to be handled individually. The frequent result is root causes are not identified and the problems reoccur.
A systematic approach based on process and systems thinking and the DMAIC problem solving and improvement framework is presented, discussed and illustrated. The focus is on getting to root cause and putting permanent fixes in place so that the problems do not occur again. The concepts and methods involved to meet these objectives are introduced and illustrated with pharmaceutical and biotech case studies and examples.
Session Highlights
  • What is Root Cause Analysis?
  • Current Approaches: Strengths, Limitations and Tools
  • Systematic approach – Roadmap and Tools
  • Use of Define, Measure, Analyze, Improve and Control (DMAIC) problem solving model
  • Solving system failure problems
  • Integrating Corrective Action and Prevention
  • Sustaining the Elimination of Root Cause
  • Importance of Periodic Management Review
  • Systematic Approach for Deviation Reduction
  • Tips, Traps and guidelines for successful root cause analysis

     
Learning Objectives

• Understand the Strengths, Limitations and Tools of current Approaches to Root Cause Analysis
• Systematic Approach to Root Cause Analysis: 
o What it is, Why it is Needed and How to Implement the Approach 
• How to Sustain the Elimination of Root Cause and the 
o Importance of Periodic Management Review
• Tips, Traps and guidelines for successful root cause analysis


Who Will Benefit
  • Production Managers
  • Quality Assurance Managers, Scientists and Engineers
  • Research and Development Scientists
  • Product Development Personnel
  • Lab Testing Personnel
  • Biologists and Microbiologists
  • Chemists and Chemical Engineers
  • Process and Manufacturing Engineers
  • Quality Engineers
  • Supply Chain Professionals
  • Process Improvement Professionals


Speaker Details


 Speaker

Ron Snee is Founder and President of Snee Associates, LLC, a firm dedicated to successful implementation of process and organizational improvement initiatives. 


 Wcs Seminars
Registration Details
(Contact us : 844-267-7299 | 954-947-5671  
Don't wait. Register TODAY or  Email  US [email protected]

Event Categories
Keywords: pharmaceutical




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