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FDA, GMP, Annex 1 – there are many regulations that cleanroom industries follow to comply with contamination control and proper protocols in producing products. In this podcast, Dave Nobile -Technical Services Group Manager, Amy Russ - Global Product Manager, Neil Simpson - Technical Service and R&D Manager, and Karen Rossington - European Marketing Manager, discuss regulations, quality risk management and how it affects a facilities process in contamination control practices and product production.

Contec offers Contamination Control Assessments in both North America and Europe to help facilities maintain best practices and comply with these regulations. More information can be found at https://www.contecinc.com/assessments/. Upcoming events include Europe’s first ContecTalks European Summit on April 29 (https://www.contectalkseurope.com/) and the 7 “Deadly” Sins of Contamination Control on May 19 (https://www.contecinc.com/upcoming-webinar/).

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Hosted By

Daniel Crowe

Daniel Crowe is Contec’s multimedia manager. Daniel is a multi-award winning and Emmy-nominated media producer, who worked in broadcast network television prior to joining Contec in 2014. Daniel is also one of the few US-based Adobe Certified Experts. His work has been observed on local TV, national networks, and companies like CBS, NBC, CNN, The Weather Channel, ESPN, Fox News Channel, The Today Show, Major League Baseball Network, Sports Illustrated, General Motors, Michelin, CVS, Highlights, Haas Automation, and more.

Karen Rossington is a technical marketing consultant specializing in the life science contamination control industry currently working for Contec Inc.  With a BSc in Business Studies and Engineering, Karen has spent 25 years in the industry in both sales/marketing and R &D roles.  Karen has presented across the world at ISPE, PDA, R3, PHSS, Pharmig, etc  on the subject of disinfectant testing and contamination control, and is a guest lecturer on contamination control for Manchester University’s Masters Degree course in Pharmaceutical Technology and Quality Assurance.

Guest

Neil Simpson

Neil has over twenty years of experience in the contamination control industry, supporting pharmaceutical, biomedical and other critical industries.

Currently the Technical/R&D Manager for Contec in Europe, Neil developed Contec’s cleanroom disinfection products for European and other global markets.

Neil is a microbiologist with extensive expertise in the field of chemical disinfection and has developed disinfectant products and processes for cleanroom use worldwide, including a product design patent.

Neil has conducted seminars and presentations globally on cleanrooms, disinfectants, and GMP requirements, and has co-authored published articles such as ‘Virucidal testing of Cleanroom Disinfectants’ and has assisted facilities in selecting appropriate disinfectants, wipes, and mopping systems for use in critical and controlled environments.

As Quality Manager for Contec, Neil was instrumental in establishing Contec’s European disinfectant manufacturing and was integral in gaining ISO 9001 for their European manufacturing site.

Previously Technical Development Manager for Shield Medicare/Ecolab for nearly 10 years, Neil holds a degree in Applied Biology and Microbiology from the University of Wales Institute.

Guest

Dave Nobile

More than thirty-six years of experience in developing products and processes for cleanroom as well as industrial applications makes Dave Nobile a key technical resource in contamination control for the pharmaceutical, biomedical, microelectronic, disk drive, aerospace, and other critical manufacturing industries. He is currently Technical Services Manager for Contec, Inc.

Dave has conducted numerous seminars, presentations, and webinars including “Wiping Theory and Techniques,” “Cleaning the Cleanroom,” and “The True Value of Presats.” He has written several articles related to cleanroom contamination control, and co-authored the technical paper “The Cleanliness of Wiped Surfaces: Particles Left Behind as a Function of Wiper and Volume of Solvent Used.” As a product development engineer, he has received multiple design patents for innovative cleanroom products.

Dave is currently the Technical Vice President for the Contamination Control division of the Institute of Environmental Sciences and Technology (IEST) and is the past chair of the IEST Working Group to revise the IEST RP-CC-004 test methods “Evaluation of Wipers Used in Cleanrooms and Other Controlled Environments,” to be published in 2019.

Guest

Amy Russ

Amy Russ is a self-described jill-of-all-trades, As Global Product Manager of Contec’s Cleanroom division, Amy serves in a variety of roles from product life cycle management to technical support. Graduating summa cum laude from Clemson University with a degree in Biological Sciences, Amy began her career at Contec in 2010 as a Quality Engineer focusing on continuous improvement of Contec's products and processes before moving to Product Management in 2015.