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Problem Solving - Root Cause Analysis in Pharma manufacturing

Thursday, 05 July 2018   10:00 AM PDT, 01:00 PM EDT

Training Duration = 75 min                  Sponsored by Online Compliance Panel

Click Here to register $250.00

Click Here to register and receive CD recording $500.00

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.

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.

Learning Objectives:

  • 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.

Topics

  • 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

Instructor

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.