Problem Solving - Root Cause Analysis in Pharma Manufacturing

Duration: 75 Minutes
flat 40% off on this webinar use promo code
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 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
Get life time access with download option!
Book this course
Pay Now
  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Upon earning a degree in Zoology from North Carolina State University, Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing environmental monitoring and sterility testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their quality control lab. In 1998, Ms. McElroy 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, she moved into equipment qualification and cleaning validation at Mallinckrodt.

With over 20 years of total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.

In 2013, Ms. McElroy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.


View More