Considerations of Temperature Mapping and Datalogging for GMP-Regulated Products
August 20 2014
Margaret Stava – Labequipco
Jason Daoust – Masy Systems
Validation Dataloggers: Trends, considerations, and options in use today
Kevin Loomis – Panasonic Healthcare NA
Chamber mapping: Current best practices, choosing the right temperature mapping equipment, and protocol considerations
Our speakers will be presenting on history, trends, and future considerations of temperature mapping of various chambers along with the various dataloggers that are used for different purposes. They will discuss revision protocols and impact assessment when making changes to an SOP. They will discuss various types of equipment that are used along with the procedures involved in temperature mapping various types of chambers. Staying on top of emerging trends is key to being in compliance in order to pass an FDA audit.
About the Speakers
Jason Daoust is the Business Development Manager for Masy Systems, Inc. He has been with Masy for over 8 years and has an in-depth knowledge of industry trends and technology. Jason has worked with multiple data logger manufacturers and is heavily involved in testing the functional capabilities to determine form and fit for validation use in cGMP environments. He works closely with hundreds of validation and calibration service companies and departments listening to their needs and providing the right products for them to be successful in completing their work. Jason regularly performs training on the use of validation data loggers in cGxP environments to some of the largest and smallest companies in North America. Prior to Masy, Jason worked as an independent business consultant working with product evaluations and release.
Kevin Loomis currently heads and manages the Panasonic Healthcare department for validation services and engineering support. His department is responsible for assisting customers in meeting regulatory requirements in pharmaceutical, biomedical, clinical and academic environments. He also providesvalidation related support and consultations to Panasonic engineers, customers and distribution professionals worldwide. His department’s validation offerings have centered on long established “cGMP” and “GAMP” approaches, where quality by design is considered equally as important as quality by performance. Prior to Panasonic, Kevin was a field service/ validation engineer with Thomas Engineering. Kevin has had the opportunity to work with many major institutions around the world in providing validation support.