Problem Solving - Root Cause Analysis in Pharma Manufacturing

Duration: 75 Minutes
This topic will touch on investigations whether they are post-Audit, Deviation related, Complaints, etc. It will transition into determination of RCA, the many tools used during RCA & what they really are and how to use them to greater effect.
Root Cause Analysis in Pharma Manufacturing
Instructor: Joy L McElroy
Product ID: 503456
An emphasis will be placed on a notion that there is "No such thing as Human Error", and why the possibility of Human Error should not be considered when conducting any RCA. There will also be mention of CAPA and why Training is never enough to be considered a true CAPA.

Objectives of the Presentation
  • Relevant inspection steps in relation to Root Cause
  • How to use RCA to better effect
  • What RCA tools really are and their place in RCA
  • Why Human Error doesn't exist
  • How to use your RCA to formulate better CAPAs
Why Should you Attend
RCA is typically used as a reactive method of identifying event causes, revealing problems and solving them. Analysis is done after an event has occurred. Insights in RCA may make it useful as a pro-active method. In that event, RCA can be used to forecast or predict probable events even before they occur. While one follows the other, RCA is a completely separate process to Incident Management.

Attend this training if you are dealing with deviations, non-conformances, a high error rate, a low yield rate, a high number of RCA assessments determined to be due to Human Error. And any company that finds repeat non-conformances despite the RCA or CAPA used.

Areas Covered
  • Investigations
  • Root Cause Analysis
  • RCA Tools
  • Human error is never the sole root cause
  • RCA in relation to CAPA
  • Why training is not a CAPA
  • How to deploy more effective CAPA based on RCA
Who will Benefit
  • Regulatory
  • Senior management
  • Production management
  • Process Automation Staff
  • Manufacturing Operations Staff
  • Validation Specialists
  • Quality Assurance Personnel responsible for RCA/CAPA
  • Quality Control and Research
  • Analysts and other laboratory staff
  • Regulatory Affairs
  • Process engineers
  • RCA/CAPA related individual
  • Environmental Health Safety – Mangers, team lead and supervisors
  • Product Development Analysts
$375
Recorded Session for one participant
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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Instructor Profile:
Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.

With 19 years of experience as a consultant, and over 25 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Technical Writing, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest.

Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer, technical writer, and trainer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Cleaning Validation, and GMP Compliance Auditing, and technical writing.

In 2013 Joy started, Maynard Consulting Company, which provided engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States.

In 2019 she opened her own company, McElroy Training and Consultancy, LLC which provides consultants for various projects as well as on and off site training to pharmaceutical and biotech companies throughout the United States, Canada, and the world.

Joy also spends her time mentoring and speaking as an Empowerment Speaker. Her goal is to empower people all over the world to live their dreams though implementing 5 simple techniques she has learned and applied through the years.
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