“Equipment process validations are becoming one of the tissue banking industry’s most pressing regulatory compliance concerns. Until recently, the tissue industry has enjoyed a comparatively less regulated environment than medical device manufacturers and other medtech service providers. But a surge of regulatory attention focused on validations begs the question; do equipment and supplies used to process tissue need cleaning, disinfection, and sterilization validations?”
– Alpa Patel, Nelson Laboratories, Inc. Senior Scientist
This September, Nelson Laboratories, Inc. Senior Scientist Alpa Patel will be co-presenting with MTF’s Joel Osborne at the annual American Association of Tissue Banks (AATB) Meeting. Their breakout session, Equipment Cleaning and Disinfection Validations (September 18, 2014, 1:45 – 2:30 pm), will highlight regulatory issues and provide solutions for the tissue industry’s latest compliance challenge – process validations.
Alpa Patel will be teaching about process validation and how this long-standing medtech industry practice now impacts tissue banking facilities. Joel Osborne will highlight how facilities can avoid regulatory scrutiny by getting their cleaning and disinfection validation plans in place.
Course topics include:
- Why cleaning and disinfection validations are vital
- When to validate, and what is involved
- Consequences of ignoring your validation plan
Nelson Laboratories will have consultants available to AATB Conference participants at their booth (#14) to answer any questions about tissue process validation and other tissue testing related matters.
2014 AATB Meeting
Date ǀ September 16 – 20, 2014
Location ǀ Hilton San Diego Bayfront 1 Park Boulevard San Diego California 92101
Booth ǀ #14
Course ǀ Equipment Cleaning and Disinfection Validations
Presenters ǀ Alpa Patel, Nelson Laboratories, Joel Osborne, MTF
Date ǀ September 18, 2014
Time ǀ 1:45 – 2:30 pm
To learn more about tissue process validation, Alpa recommends you read Equipment Cleaning, Disinfection, and Sterilization Validations – The Tissue Industry’s Compliance Challenge!, and Importance of Cleaning and Sterilization Validations, Even When They May Not Be Required. You may also contact Nelson Laboratories at www.nelsonlabs.com, 800-826-2088, or [email protected].