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Kymanox
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The biggest success factor for projects is having a documented, clear, and elevating project objective right at the start. Kymanox offers in-depth training for your Project Management Office (PMO). Here, Mitchel Kevern, MEM and Stephen M. Perry are moderating a 2-day workshop to demonstrate the Kymanox PM Toolkit.
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A big thank you to PDA Southeast Chapter, the world's most active PDA group. Yesterday's Fall Conference on Aseptic Manufacturing provided attendees with valuable insights and relevant take-homes. Kymanox is proud to sponsor this non-profit organization and looks forward to seeing how this group will continue to change the face of modern medicine.
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Kymanox is working with clients to mitigate the opioid crisis. Look here for one way of addressing the issue.

http://www.newsobserver.com/news/business/article181287526.html
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Thank you for following Kymanox. You can also find us on LinkedIn, Facebook, and Twitter, or visit us at kymanox.com.
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It's National Prescription Take Back Day! The National Prescription Drug Take Back Day aims to provide a safe, convenient, and anonymous means of disposing of prescription drugs, while also educating the general public about the potential for abuse and medications. Those located or working in RTP can drop off their unused medications at the National Institute of Environmental Health Service at 111 TW Alexander Drive, RTP, NC 27709.
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Welcome Jaime Rain, Principal Scientist!

Jaime holds a Master of Microbial Biotechnology from North Carolina State University and a Bachelor of Health Science from the University of Kentucky. She is a scientist with an expertise in Microbiology and Environmental Monitoring, and has been extensively involved in validation of QC laboratory test methods, as well as qualification of manufacturing room environments. She also has experience with aseptic processing and bringing a company from startup to full GMP operations.
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What do you find the most challenging part of scaling up your process is? #fillintheblank
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Welcome Faith Fraley, the new Sr. Manager of Validation at Kymanox!

Faith is a proven team leader with the ability to focus and motivate individuals, as well as provide individual quality results. She has been in this industry for over 18 years and specializes in design, documentation, installation, and validation of new equipment, facilities, utilities, and processes. Her experience includes working with quality systems in commissioning, validation, reliability engineering, and product/process. She has lead and supported projects from basic and detailed design to procurement, construction and installation and testing from commissioning through process validation.
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Check out our blog post on Form FDA-483s and Warning Letters to see the top 10 FDA warning letter findings for finished pharmaceuticals.

https://kymanox.com/2016/12/13/483-warning-letter/
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Medical device friends:

Kymanox is equipped to support your transition to ISO 13485:2016 through gap assessments, quality planning, quality management system development, and remediation activities. We have trained auditors on staff and can work remotely or at your site to help you prepare for the certification audits. Let us identify the problem areas before the certification bodies arrive.

Feel free to contact Kymanox Client Services for more information or visit the Kymanox website (www.kymanox.com) to learn more about our breadth of service offerings.
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