CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations

Angela Bazigos
Instructor:
Angela Bazigos
Date:
Wednesday, June 26, 2019
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
90 Minutes

More Trainings by this Expert   Product Id : 502546

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
Combo Offers
Live + Recorded
$289 $340 Live + Recorded
Corporate (Live + Recorded)
$599 $680 Corporate
(Live + Recorded)
Price Detail Options
Overview:

This live interactive presentation will also discuss the regulations associated with the detection, correction and prevention of human errors in GMP manufacturing and laboratory processes.

Why should you Attend: We are often quick to ascribe fault to people rather than our systems, facilities, and operations. However, in this class, we will learn how to tell if you are too quick to ascribe guilt to people rather than probe deeper. We will focus on improved techniques to get to the real cause of the problem. With this information you will be able to develop meaningful CAPAs that have a chance to remedy these problems, the first time.

We will focus on how to assess the success of these CAPA's. This will lead to a significant reduction of repeat observations which will lead to improved efficiency and right first time operations.

Areas Covered in the Session:

  • Identify why human error is often designated the root cause of deviations and discrepancies
  • Identify why your CAPA's are less effective than you hoped
  • Understand why human error is not the real cause of the deficiencies and deviations
  • How to probe further to identify the causes or contributing factors that really cause the problems you are seeing
  • How to develop a true CAPA for these problems
  • Develop an efficient and effective CAPA system to remedy the ingrained problems
  • Identification and prevention of human error during data entry
  • Most common GMP issues caused by human error during laboratory and manufacturing processes

Who Will Benefit:
  • Quality Assurance Personnel
  • Quality Control Personnel
  • Supply Chain and Logistics Managers
  • Regulatory Affairs Professionals
  • Process Development Scientists and Management
  • Manufacturing Management and Scientists
  • Project Managers working in the CMC arena


Speaker Profile
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.

Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA Patent on speeding up software compliance https://www.google.com/patents/US8266578.

Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom includes training for Society of Quality Assurance.

Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for LifeSciences.




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