23SEP08: Stephen Perry of Kymanox Speaks at PDA Event
Raleigh, NC, USA | Stephen M. Perry, PMP, President of Kymanox, spoke today at the PDA Southeast Chapter's Fall 2008 Meeting (click here to view the event brochure). Stephen's talk was titled "Leveraging Statistical Methods and Analysis for Validation" and addressed the fact that “n=3=validated” is not consistent with the FDA’s 21st Century approach to quality and new global quality systems such as Q10. Adopting the principles of QbD also means adopting practices that are rooted in sound science - which includes statistics. It is imperative that validation efforts utilize statistical methods to help determine sample sizes, acceptance criteria and related data evaluations. With proper awareness and training, both technical and quality individuals should be able to use the most common statistical tools and know when situations require consultation by a trained statistician.
A 1-page memo (click here to view) summarizing this improved approach to determining validation sample sizes was provided to event attendees and the entire presentation is available upon request by contacting Stephen at +001 847-239-2710.
Kymanox also participated at the event as a sponsor and was appreciative of all the support given by the attendees and PDA. Justin Pawlik (Associate Director, Midwest Operations) and Timothy Miller, MS, MBA (Technical Project Manager) were present from Kymanox.
04MAR08: Kymanox launches KymaStore™
Highland Park, IL, USA | Kymanox has launched KymaStore™, an online store offering new products for a variety of needs in the pharmaceutical, biotechnology and life science industries. KymaSTORE is a brand new offering from Kymanox, and will add new products on a continuous basis.
The templates available are "project accelerators" since they can be downloaded in minutes to provide the quick start a project task may require. Training packages are designed to provide complete solutions to your training needs; the packages can be edited for further enhancement or branding. KymaSTORE is also a licensed distributor for GMPPENS.COM.
31JAN08: Kymanox is creating a Solar Buzz
Highland Park, IL, USA | Kymanox, LLC has announced that it will be launching a solar panel installation project. The focus of the project is to make solar panels more accessible to the masses. Kymanox is demystifying a technology that is sure to be a critical player in the energy crisis debates that have already begun. The project was just launched in September 2007 and will be publicly implemented by December 2008.
In support of this technology and environmental sustainability, Kymanox has dedicated time and resources to develop the expertise related to solar energy. Kymanox will leverage its versatile technical project management capability in both Highland Park, IL and Research Triangle Park, NC. With that knowledge, Kymanox will manage and document the implementation process for solar panel distribution from conception to installation. At least one organization will be awarded a 90% funded solar panel installation (up to 3kW), courtesy of Kymanox and our partners, to propagate the understanding of solar panels and their utility in today’s energy market.
The process of installing one solar panel or even an entire system should be as easy as buying a new fence for your house. Kymanox and our partners will do just that with this project. The future is our collective responsibility.Visit the Kymanox SOLAR website.