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For Large Companies: If you simply need a skilled professional, a medical device consultant to work independently, to complete a project that you just do not have enough sterilizer validation or microbiology staff to get finished, let us know. Get your project completed on time and in compliance.
For Small Companies: If you need a medical device consultant to navigate the sterilizer validation process with you, to determine critical issues, write protocols, execute validations, solve problems, review results and compare to published standards, prepare final reports, write SOPs, and train staff, I can take care of all those needs for manufacturers that may be new to sterilization processes or new to the FDA/ISO environment.
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Mark Dott received an M.S. degree in Microbiology in 1983, is a member of AAMI and RMRAS, and has been providing skilled consulting services since 2002, with access to may other experts in the sterilization industry. References and resume available upon request.
He was an invited presenter for training webinars on Steam Sterilizer Validation per ISO 17665, EO Sterilizer Validations per ISO 11135, and Gamma Sterilization per ISO 11137. He has also presented training sessions for Cleanroom Practices and Cleanroom Aseptic Techniques, Cleanroom Gowning Practices, Temperature Monitoring for Environmental Storage Chambers, and authored an article on Steam Sterilizer Validation per ISO 17665 for Controlled Environments magazine --- No. 10, Volume 10, November 2007, p. 11-16.
With over 25 years industry experience, covering a wide range of medical devices, permanent implants, surgical disposables, combination products, biologicals, and human tissue products (HCTPs), he has validated or supervised processes for
- Gamma sterilization
- Ethylene oxide sterilization
- Steam sterilization, and
- STERRAD sterilization
- Product Adoption SOPs.
He has validated USP/AAMI microbiology test methods for use in GMP laboratories, and is skilled with cleaning-resterilization process validation for reusable instruments, kits & sets, and disinfectant validations for cleanrooms. Other areas include
- Bioburden, sterility testing, and biological indicator testing
- Instrument and sets cleaning validation per AAMI TIR 12 and TIR 30
- Employee training on many topics
When compliance is your priority, call us.
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