Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing

Product Id : FDA70
Instructor : Joy McElroy
Dec 12, 2017 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

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Overview

Total organic carbon (TOC) is an analytical method for validating cleaning processes, which helps in detecting and quantifying the carbon content from various different sources. Many laboratories are required to conduct a TOC analysis, so if you happen to be responsible for one of them, it is important that you understand the process, so you do not encounter any difficulty.

Join us for this webinar, during which our expert speaker Ms. Joy McElroy will walk you through the subject of total organic carbon analysis, delivering useful information and explaining the concept in detail. During this webinar, you will learn about the chemical basis of TOC analysis and its principles, validation of TOC for cleaning validation purposes, optimization of TOC recovery, sampling and analysis, and the benefits of at-line and on-line sampling – and the differences between them.

Other topics under discussion include:

  • Analytical approaches in different instruments
  • Why TOC analysis is used and situations where it is preferred
  • How to set limits based on TOC, how to use blanks and controls
  • How to group strategies together for analytical method validation, cautions to be taken in sampling and analysis
  • How to deal with interferences, optimization of TOC recovery for solubilize compounds or ones that are difficult to oxidize
  • How to use TOC analysis throughout the validation lifecycle, and an overview of regulatory issues

Training Highlights:

  • Go through the principles of total organic carbon analysis
  • Discover the analytical approaches in different instruments
  • Learn the reasons for using TOC, and situations where it is preferred
  • Learn about the usage of blanks and controls
  • Learn how to set limits based on TOC
  • Learn how to deal with interferences
  • Learn about optimization of TOC recovery for compounds that are difficult to oxidize
  • Learn how to group together strategies for analytical method validation
  • Learn about cautions to be taken during sampling and analysis
  • Learn about the usage of TOC analysis throughout the validation lifecycle
  • Go through regulatory issues
  • …and much more

All webinar attendees will be provided handouts which will help them remember and make the most of what they have learnt during the training session.

Who will benefit:

The following people will benefit from, and should therefore attend, this webinar:

  • Personnel directly involved in developing cleaning procedures, validation programs and plans
  • Personnel responsible for cleaning validation protocols and execution activities
  • Personnel that communicate with inspectors to rationalize or defend cleaning validation programs
  • Analytical method developers
  • Quality control and quality assurance personnel
  • QA and QC managers
  • Operations managers
  • Cleanroom operators and managers
Speaker Profile:

Joy McElroy has 25 years’ experience in the pharmaceutical industry. She took her first steps into the industry in 1992, when she performed environmental monitoring and sterility testing at Pharmacia & Upjohn. Soon after, she became the supervisor at Abbott Laboratories, where she was responsible for overseeing the quality control lab. In 1998, Ms. McElroy was hired by Wyeth Lederle to work in quality assurance – where she performed GMP compliance audits, reviewed batch records, and held annual GMP training for new employees. After a few years working there, she moved to Mallinckrodt, where she was in equipment qualification and cleaning validation.

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


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