The ever-changing regulatory environment faced by manufacturers in pharmaceuticals and other regulated industries can cause confusion and doubts about compliance. Instrument systems designed to meet regulatory requirements can relieve the burden for manufacturers. How do they do it?
Watch this webcast to see how two different instrument platforms—Fourier-transform infrared spectroscopy (FTIR) and microvolume ultraviolet-visible (UV-Vis)—help labs assure compliance in their processes.
The Thermo Scientific™ Nicolet™ Summit FTIR Spectrometer (for raw and finished material QA/QC) and the Thermo Scientific™ NanoDrop™ One Spectrophotometer (for DNA, RNA, and protein quantification) provide confidence when approaching your next audit.
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During this webcast, you’ll learn:
- How 21 Code of Federal Regulations (CFR) Part 11 is managed with innovative software controls
- The simplified workflows to create and deploy standard operating procedures
- Why ongoing performance verification tests can give you peace of mind
Key Learning Objectives:
- How to enable 21 CFR Part 11 in the lab
- How to use workflows to ensure compliance from each analyst
- How to leverage built-in performance tests to consistently check instruments are fit for purpose
Who Should Attend:
Lab managers in regulated environments (pharma, biopharma)
Product Manager for FTIR Spectrometers
Thermo Fisher Scientific
Matt Gundlach is a product manager for FTIR spectrometers at Thermo Fisher Scientific. In his current role, Matt leads a team in developing and marketing spectroscopy products in a variety of end markets, including pharmaceuticals, polymers, and academic teaching. Matt’s group focuses on small form factor laboratory spectrometers that are used to conduct analysis in QA/QC and analytical services environments. He joined the company in 2015 and holds a chemistry degree from Carthage College, where he also studied physics and entrepreneurial business.
Product Marketing Specialist for Microvolume UV-Vis Spectrophotometers
Thermo Fisher Scientific
Patrick Brown is the product marketing specialist for Thermo Scientific NanoDrop Microvolume UV-Vis spectrophotometers. In this role, Patrick collects user feedback, integrates feedback into software and hardware updates, and works with marketing teams to communicate these benefits to end users. The NanoDrop spectrophotometer product line is used by scientists around the world to quantify and qualify DNA, RNA, protein, and other molecules. Before joining Thermo Fisher Scientific in 2015, Patrick earned a master’s degree in biomedical sciences from The Pennsylvania State University.