Stefani Godoy Herrera

Aug 15, 2024 | meddeviceonline.com | Ulrich Lein |Stefani Godoy Herrera

With over 35 years’ experience in the medtech, diagnostics, and pharmaceutical markets, SMC Ltd. provides in-house engineering, injection molding, assembly, fill finish, device manufacturing, packaging services, and can manage sterilization. Our customers rely on us for speed-to-market and our program management process is a key to well managed projects. With inhouse global supply chain expertise, we help customers reduce risk while maintaining tight timeframes.

Aug 13, 2024 | laboratorynetwork.com | Yadnyesh Patel |Ulrich Lein |Stefani Godoy Herrera

By Yadnyesh Patel, microbiology subject matter expertIn this second article of a planned series about bacterial endotoxin testing, the author shares best practices about prerequisites and reagent preparation for a gel clot Limulus amebocyte lysate (LAL) test. By Ulrich Lein and Stefani Godoy Herrera, MAIN5The computer system validation (CSV)/computer system assurance (CSA) process is correlated with other departments besides IT and quality.

Aug 1, 2024 | biosimilardevelopment.com | Yadnyesh Patel |Ulrich Lein |Stefani Godoy Herrera |Nigel Stapleton

Get more biosimilar development insight with our FREE newsletter Newsletter | August 1, 2024 PDA/FDA Joint Regulatory Conference 2024 The PDA/FDA Joint Regulatory Conference 2024, the only FDA co-sponsored pharmaceutical CGMP conference, is taking place 9 to 11 September in Washington, D.C. Now in its 33rd year, the conference will offer a comprehensive agenda with substantive technical sessions and practical case studies that provide insight into the effective application of Current Good...

Jul 31, 2024 | outsourcedpharma.com | Louis Garguilo |Ulrich Lein |Stefani Godoy Herrera |Nathan Dormer

What's your development and manufacturing outsourcing strategy based on? Do you have the right contracts and external relationships in place to successfully implement that strategy? Are there new models for sponsor-CDMO partnerships? Join Outsourced Pharma Live on August 13th as our panel of professionals will provide personal analysis and ideas for determining how you might best conduct your development and manufacturing activities, outsourcing business models, and external relationships.

Jul 17, 2024 | pharmaceuticalonline.com | Ulrich Lein |Stefani Godoy Herrera

By Ulrich Lein and Stefani Godoy Herrera, MAIN5 Any system relevant to GxP (good practices) in life sciences is required to undergo a formal process of computer system validation (CSV) or assurance (CSA) to confirm that it fulfills its intended purpose. The common preoccupation with the resource-intensity of this undertaking downplays its more strategic role for the organization. At the current time, this is likely to include enabling more dynamic and seamless data sharing.