Hello and Welcome to the Virtual Pharma Users Group

[#1]

I'm somehow one of the group owners, and by way of a quick introduction, I'm also one of the JMP Systems Engineers (like a field application specialist) for Pharma companies in the north east. My background is in cell and molecular biology and I spent a lot of time working on different vaccines before JMPing in.   I tend to spend more time working on unfortunate data formats, but prefer DOE, comparability and CPV projects, and of course, all things potency assay related. 

If you wouldn't mind, drop a quick bio to the growing group, I think we could end up having some fun and interesting discussions here.  

Cheers,

Byron

[#2]

My name in Andrea Coombs and I am also a JMP Systems Engineers supporting pharma and biotech and other industries in the east.  My background is in agriculture (which has its roots in statistics) and pharma.

[#3]

I am new to JMP. Do you know whether JMP is 21 CFR part 11 compliant?

[#4]

Hi @pgviz, As a software provider, we don't conduct audits with external regulatory agencies like FDA (or other notified bodies OUS), so we cannot state or otherwise certify compliance to 21 CFR part 11.  That said, we do provide resources and tools to assist with your compliance assessment, as well as your software verification and/or validation activities -- see JMP Trust Center | Compliance and our quality statement page: Quality Statement | JMP.  Also, See Appendix 1 of the  The SAS Quality Imperative Document (PDF) (also hyperlinked at the bottom of the Trust Center page) -- under the section "Complying with Title 21 CFR Part 11."  Hope this helps! 

-JMP Technical Support  

[#5]

I'm Tim Hershner and serve on one of JMP's Health & Life Sciences teams. I grew up in a family of HCPs and by my mom's side at the University of Cincinnati's Department of Chemistry and College of Medicine. I always wanted to become a physician but was diagnosed with an autoimmune condition that prevented me from pursuing this career path. So I pivoted and have focused my career on improving health equity and positively impacting health outcomes and quality of life for patients like myself who benefit from pharmaceutical discoveries like biologics. I'm excited to join the group and look forward to meeting other members at our upcoming meetings.

[#6]

Wow @TimHershner, thanks for sharing your story!  You've inspired me to do the same. 

I'm Patrick Giuliano and am currently on JMP's technical support team.  I was always curious about biology and medicine (how the human body works) growing up and found my way into biomedical engineering as an undergraduate student at the University of California San Diego (UCSD). I then studied the mathematical and theoretical basis for solid mechanics applied to biological systems, learning finite element methods in a masters program also at UCSD. That took me into the medical device industry where I spent 15 years mostly supporting the development and commercialization of catheter-based implantable medical devices in mfg, quality, process and DV&V testing roles.  I've already benefit from the mind-share in these meetings and appreciate the collaboration from this group.