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Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing - Webinar

  • ID: 4210037
  • Webinar
  • May 2017
  • Region: Global
  • 60 Minutes
  • Online Compliance Panel
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Total Organic Carbon (TOC) is a useful analytical method for cleaning validation studies, including design, qualification and routine monitoring. While there may be some confusion with the industry and regulatory bodies about the use of this analytical technique, it is widely used because of certain benefits. The basis of TOC as an analytical technique will be covered, involving the various technologies currently utilized. Cautions in sampling and analyses will be discussed, including the appropriate use of blank and controls.

Objectives of the Presentation:

- Understand the Chemical Basis of TOC Analysis
- Learn how to set limits based on TOC
- Learn how to validate TOC as an analytical method for cleaning validation purposes
- Understand possible interferences from sampling and analysis
- Optimization of TOC recovery for difficult to oxidize or solubilise compounds
- Learn appropriate uses of TOC throughout the validation life cycle
- Benefits of at-line and on-line sampling

Why Should you Attend?

TOC (total organic carbon) analysis is one of the most common analytical methods used for cleaning validation in the pharmaceutical industry. This nonspecific method is typically used to detect the presence of organic residues on cleaned product contact surfaces. TOC analysis is rapidly becoming the analytical method of choice for cleaning validation for several reasons. Many pharmaceutical companies are developing cleaning validation methods based on a whole-product approach: a determination is made as to whether any residue is present without regard to its origin (including products, cleaning detergents, chemicals, solvents, by-products, degradants, and microbial contaminants). This method works well with TOC analysis, which can detect any API or cleaning agent residue that contains carbon in its molecular structure.

This webinar will demonstrate Total Organic Carbon (TOC) feasibility, method validation and transfer from the laboratory to the manufacturing floor, as well as reviewing a feasibility study of multiple, difficult to oxidise or low solubility organic compounds.

Areas Covered:

- Principles of Total Organic Carbon Analysis
- Description of analytical approaches in different instruments
- Reasons for using TOC and Situations where TOC is preferred
- Setting limits based on TOC
- Use of blanks and controls
- Grouping strategies for Analytical method validation
- Dealing with interferences and Optimization of TOC recovery for difficult to oxidize or solubilise compounds
- Cautions to be taken in sampling and analysis
- Use of TOC throughout the validation lifecycle
- Regulatory issues

Topic Background:

Total organic carbon (TOC) analyzers are a mainstay in industries that must detect and quantify carbon content from many samples and sources. Unlike spectroscopy, which measures specific carbon species from their unique interactions with light, TOC analysis doesn't tell which specific carbon-containing species are present. Nevertheless, it does provide information on impurities, which is invaluable in evaluating environmental samples. TOC analysis is mandatory for many labs, particularly in semiconductors for process water; or in regulated industries that work with ultrapure water for processing, instrumentation, cleaning/ cleaning validation, or human drugs. Other industries that regularly employ TOC analysis include pharmaceuticals, foods, forensics, oil and gas, and the life sciences.
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  • Joy McElroy Joy McElroy,
    Principle Consultant ,
    Maynard Consulting Company

    Upon earning a degree in Zoology at North Carolina State University, Joy 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.

    Now with 12 years experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, Phillips Medisize, Xcelience, and Novartis.

    Joy specializes in Equipment Qualification, Cleaning Validation,Sterilization, Environmental Monitoring, and GMP Compliance Auditing.

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Attendance will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful. This includes Analytical Method Development, Quality Control, and Quality Assurance personnel.

Individuals in management who interact with the above or communicate with regulatory agency inspectors to rationalize or defend cleaning validation programs will also benefit from attending this course.
  • QA and QC managers
  • QC Analysis Technicians
  • Disinfectant validation managers
  • Operations managers
  • Manufacturing operators
  • Clean room managers
  • Clean room operators
  • Personnel and contractors that clean and disinfect clean rooms
  • Regulatory compliance managers and environmental monitoring managers
  • EH&S managers
  • Validation Engineers and Specialist
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