The ten key steps to manage and mitigate risk within life science companies
The ten key steps to manage and mitigate risk within life science companies By: Erin O'Brien Managing and mitigating risks with a structured plan is…
The Importance of CMC Due Diligence
By James Blackwell, President, Windshire Group, LLC and Labshire, LLC May 12, 2024 Download the PDF of this blog! CMC Due Diligence | May 2024…
Acquisition Rocks CMO Supply Chain Landscape
The news of the Novo Nordisk (Novo Holdings) intent to acquire Catalent has taken the industry by storm. It is unprecedented and shifts the risk…
Audit Readiness Checklist
Sooner or later, every biotech, pharma or medical device company will face an audit. Use this general checklist to evaluate your organization and take proactive…
Euro Commission Issues New Guideline for Quality Documentation Needed to Support Biologic Investigational Clinical Trials
Addressing quality requirements of an investigational medicinal product for a given clinical trial without sharing your company’s overall development strategy for a medicinal product is…
Strategies to Re-risk Supply Chains- A Geo-political Crisis Case Study
Risk Framing and Conflict Mitigation Strategies in the Ukrainian Crisis The Windshire Group’s clients are facing unprecedented challenges to their supply chains from pandemics to…
The Pandemic Caused Process Changes and Lessons for the Future
Dr. James Blackwell, Ph.D, M.B.A discusses how the COVID-19 pandemic has caused significant changes, both disruptions and accelerated development. Lessons learned can inform practices from the…
Quality Operations Success: It’s in the Details
"The following is an edited excerpt taken from The Windshire Group’s webcast Quality in the Laboratory: It’s in the Details Live Free Webcast Expert Panel Discussion…
Validation Best Practices: Considerations
The following is an edited excerpt taken from The Windshire Group’s webcast Validation: Tried and True Success Lessons from the Front Lines Expert Panel Discussion-LIVE FREE…
Conducting Proper Deviation Investigations: Critical Elements
The following is an excerpt taken from The Windshire Group’s webcast “Conducting Proper Deviation Investigations Expert Panel Discussion – Live FREE Webcast”. Daniel DeLucy: Deviation investigations are a…