Eric S. Kastango, MBA, RPh, FASHP, and Scott Sutton, PhD, will discuss USP 71, and review BUD requirements and default
Wolters Kluwer Health, a leading global provider of information for healthcare professionals and students, is hosting a complimentary webinar with Eric S. Kastango, MBA, RPh, FASHP and Scott Sutton, PhD in “Understanding USP 71-Sterility Testing and Extending Beyond-Use Dating.”
Eric S. Kastango, MBA, RPh, FASHP and Scott Sutton, PhD, will discuss USP 71 sterility testing and beyond use dating.
Their Objectives for This Webinar:
1. Review the default beyond-use dating (BUD) in USP Chapter 797
2. Review the requirements defined in the chapter in extending BUD
3. Review USP Chapter 71 Sterility Test
- Understand what Method Suitability testing is and its importance to a valid test
- Discuss membrane filtration and direct inoculation methods of sterility testing
- The importance of two media (TSB and FTM) and their respective incubation temperatures
- What does passing a sterility test mean?
Understanding USP 71-Sterility Testing and Extending Beyond-Use Dating
Date: Wednesday, July 10, 2013
Time: 1:00 PM - 2:00 PM ET
About the Presenters:
Eric Kastango is President and Founder of Clinical IQ, LLC and CriticalPoint, LLC. He was a Study Director for the 2011 and 2012 USP 797 Compliance Study. He is an active member and Fellow of the American Society of Healthcare Pharmacists and served on the USP Sterile Compounding Committee from 2005 to 2010 and was recently re-elected to the 2010 to 2015 USP Council of Experts for the Compounding Expert Committee. He is currently the Chairman of the USP Chapter 797 subcommittee.
Dr. Scott Sutton is the Principal of Microbiology Network, a company he started in 1996 as a means to encourage training and communications within the microbiological community. With over 70 publications and hundreds of presentations, he is a recognized consultant and trainer with emphasis in GMP, investigations, Environmental Monitoring and contamination control, as well as microbiology laboratory audits and operations. Dr. Sutton is an active author and speaker for the industry, supports ASM, PCPC and PDA, and has served with the USP Analytical Microbiology Committee of Experts since 1993.
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