NOTE: All On Demand Webinars are Free for Active Members - please email info@ncsli.org for call 303-440-3339 for the code

The Pharmaceutical Cold Chain - From Manufacturing to Distribution

Many regulated biopharmaceutical products are temperature sensitive, requiring that a consistent temperature range be maintained from manufacturing, to storage, to distribution to patients. This is commonly referred to as the “biopharmaceutical cold chain.” Safe and effective treatments require  consistency across the entire product manufacturing and distribution cycle, due to the temperature-sensitive nature of many biopharma ingredients. In this webinar, cold chain experts from Masy BioServices will outline each stage of a typical GMP manufacturing process, explaining the technologies and validation practices that contribute to the maintenance of consistent temperatures and thus safe and effective treatments.

This webinar will touch on:
  • Manufacturing, packaging validation, transportation validation (Part 1)
  • Warehousing, Fill/Finish, distribution (Part 2)
TUAN NGUYEN
Tuan currently is the Validation Manager for Masy's California branch. He has worked in the biopharmaceutical industry for over 6 years, bringing a wide variety of diverse experience working in Laboratory Operations, Quality Control, Quality Assurance and Validation. His Validation experience includes planning and executing over 100 validations for a small medical device company to resolve nonconformities from a regulatory body audit and leading teams on large environmental chamber projects for multiple different manufacturing facilities.


CARLIN BRAY
Carlin is a Product Manager for Masy BioServices’  state of the art Biorepository and a SME on all things GMP Storage. She specializes in providing solutions for complex storage/stability projects for customers within the Biopharma/Biotech industry.





BURKE BERO
Burke provided business development services for his own consulting company, serving Western militarizes and the defense industry  for 20 years. Since joining Masy in 2008, he has been instrumental in growing the biopharma storage business by providing customers with expert advice and industry leading customer service. Burke is an avid lacrosse fan.





JOHN ORANGE
John is a multi-faceted professional in the biopharmaceutical industry, with a previous background in the chemical industry. Over the past decade, he has championed dozens of startup projects from small laboratory expansions to large building startups. John comes to Masy with experience in laboratory support and quality operations, which adds tremendous value when speaking on behalf of the complete system life cycle with respect to laboratory instrumentation. He is a proud family man and a hobbyist who enjoys mineralogy, woodworking, and photography.






KEVIN NASKIEWICZ
Kevin is an effective sales professional with 20+ years medical device and biologics sales and sales management  experience.  He has worked with many medical device manufacturers throughout his career. He most recently owned and operated his own medical device distribution company with his two partners, focused on spinal surgery, orthopedics, biologics and pain management. Kevin joined the Masy BioServices validation team in 2019 as the first sales professional in the Mid Atlantic region.  He continues to provide the highest level of customer focused service to the BioPharma industry. He enjoys spending time with his wife and three children, coaching soccer and tackle football, playing men’s league soccer, and hosting family gatherings by the pool.

PHIL KENDALL
Phil has over 20 years of experience in a cGMP setting, from medical device manufacturing, product development and sales, to radio-pharmaceutical product management. Always the customer advocate, Phil’s deep product knowledge and willingness to listen has enabled him to help customers choose the right calibration or equipment solution for their needs. He previously worked at enterprises like RadioMed-IBA and Radionics, but came to Masy in 2017 to become part of a company that directly contributes to human health and wellbeing. Phil is an avid fisherman, and enjoys lacrosse with his two sons.