Cleaning Validation; Issues in the Use of Total Organic Carbon (TOC) as an Analytical Technique

Live, Interactive Training Webinar

Date: Thursday October 18, 2018 - Time: 9:30 AM - 11:30 AM (Eastern New York Time)
Instructor: Destin LeBlanc Biography>>>

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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. However, a key downside to TOC is that it generally makes meeting acceptance criteria more difficult. 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

Learning Benefits:
-Understand the chemical basis of TOC analyzers.
-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.
-Learn appropriate uses of TOC throughout the validation life cycle.

Webinar outline and time breakdown:

Time*
9:15 AM Log In Period
09:30 AM Introduction
09:40 AM Description of analytical approaches in different instruments,
Reasons for using TOC,
Setting limits based on TOC,
Use of blanks and controls,
10:30 AM Break
10:40 AM Analytical method validation,
Dealing with interferences,
Cautions in sampling and analysis,
Use of TOC throughout the validation lifecycle,
What regulatory documents say,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

  • A copy of the presentation slides
  • A certificate of training for attendee records

Who should attend:
This live training webinar is applicable to drug product manufacturers and API manufacturers, including biopharmaceutical manufacturers. The following individuals or disciplines involved in process equipment cleaning validation will benefit from attending this live webinar:

  • Microbiology personnel
  • Senior management responsible for cleaning validation
  • Validation, Quality Control, Quality Assurance, Manufacturing, Regulatory Affairs, Technical Support
  • Directors, Managers/Supervisors, Scientists, Technicians, Operators, Auditors
  • Regulatory Affairs Professionals

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Instructor: Destin LeBlanc

Destin LeBlanc has over twenty-five years of Technical Service and Product Development experience in specialty chemicals and medical technologies, the last ten of which have been involved with various aspects of cleaning and cleaning validation in pharmaceutical and medical device manufacturing.

Destin LeBlanc consults in the area of cleaning validation as Cleaning Validation Technologies. Previously, he had been with STERIS/Calgon Vestal for over twenty years, primarily in product development and technical service for cleaning and antimicrobial applications. He has lectured on issues related to contamination control internationally, and has written widely on cleaning validation issues. He is the author of two books Validated Cleaning Technologies for Pharmaceutical Manufacturing, Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing- Volume 1 and Cleaning Validation: Practical Compliance Solutions for... Full Bio>>>

 

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Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

"Our group enjoyed the live presentation and found the experience much more engaging and worthwhile than any recorded webcasts" Sr Training Manager, CA

"This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

"We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

"Given how recent the content of the webinar was, our team members were very happy with the relevance of the training" VP Clinical Operations, CA

"Is my first time to attend training, I enjoy it very much" Sr Manager, Korea

"Our department found the level of interactivity between the audience and the instructor far beyond that of any other online training that we have attended before. Well done" Director Regulatory Affairs, ON

"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

"We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland