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FDA 21 CFR 820 - QSR Session # 2: "Managing Microbial Contamination in Ter...

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Stellartech Research Corporation

560 Cottonwood Drive

Milpitas, CA 95035

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FDA 21 CFR 820 - QSR Session # 2:

"Managing Microbial Contamination in Terminally Sterilized Products"

ASQ NCDG February 2018 Roundtable

Wednesday, February 28, 2018, 7:00 - 9:00 pm


Managing microbial contamination in terminally sterilized products is critical to ensure sterilized product quality.

Biological Indicators (BI) used for sterilization are bacterial spores, whereas the hard to sterilize microorganisms are mold. Similarly during cleaning as disinfection, if the program is not science based, bacterial and mold spores will prevail. Cleaning is in itself a science not an exercise.

Microbial identification is not performed if pre-sterilization bio-burden testing is within specifications; if majority of bio-burden are hard to kill and to sterile spores, product sterility test failures are inevitable. Understand the structures of these tough microorganisms and develop a program to track them.

This presentation will address:

  • Understanding bacteria and mold

  • Sources of bactgeria and mold found in the cleanrooms

  • Understanding disinfectants; efficacy of disinfectants commonly used in the industry against different cleanroom contaminants

  • Guidelines on developing a scientifically sound disinfection and cleaning program

  • Common errors in disinfection and cleaning that lead to contamination issues

  • Consequences of predominance of bacterial and fungal spores in cleanrooms

Featured Speaker: Ziva Abraham

Ziva Abraham is the President and Founder of Microrite, Inc., a San Jose, California based consulting firm providing consulting and training services to pharmaceuticals, biotechnology, medical devices and other healthcare related industries worldwide. Ziva has over 25 years of academic, research, clinical and industrial experience in microbiology, and quality assurance. Ziva has received her Master’s Degree in microbiology and has conducted research on developing microbial Insecticides using entomogenous bacteria and fungi towards her Ph.D. degree. Her career also includes founding and managing clinical laboratories for Maccabi Medical in Israel. She uses her extensive experience to teach why assessing risk of contamination should be on the forefront of any company that has products for human/veterinary use. Her experience in clinical laboratories has provided her with the framework to understand the effects of microbial contamination in products from a patient safety perspective.

Moderator: George Marcel

George Marcel is an QA professional and ASQ senior member holding multiple ASQ Certifications. George is currently active with the ASQ Biomedical Division, NCDG, and Silicon Valley Section. George is a presentation reviewer and moderator for the ASQ WCQI annual conference, ASQ certification and subject class trainer for the ASQ Sillicon Valley Education Program,and subject matter expert for multiple Quality initiatives (ASQ Management Division, MBNQA, etc.). George is Director of Quality Assurance at Focal Therapeutics.

Registration Link: NCDGFEB2018.eventbrite.com

Register online early for discount & save.

Only Credit Card accepted at door (via Eventbrite)

Location: Stellartech Research Corporation, 560 Cottonwood Dr., Milpitas, CA 95035

Food: Snacks equivalent to a light meal and beverages are provided at each event at no additional cost.

Email: To be added to or removed from our email list, contact George Marcel: gjmarcel@gmail.com

Questions: For information about this session, contact George Marcel: gjmarcel@gmail.com

Formal discussion and questions will end between 8:30 - 8:40 pm to allow time for networking.

Materials: Presentation & workshop sheets provided for onsite attendees only.

Please limit distribution to attendees: personal professional use only.

For those not in the Northern California / Bay Area, and those locally who cannot attend the session, in person:

Webinar Remote Access (no cost) Option: https://attendee.gotowebinar.com/rt/6376324503535979521

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Stellartech Research Corporation

560 Cottonwood Drive

Milpitas, CA 95035

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