Insights On Regulatory Compliance
-
Esco IntelliGlove Tester (EIGT)
2/19/2026
Ensure sterility with wireless glove leak testing. Align with Annex 1 and ISO standards through portable, traceable, and cable-free integrity checks that optimize cleanroom safety and workflows.
-
Human Performance In Pharma: Strengthening The Biotech Workforce
11/24/2025
Transforming the pharma workforce requires strategic partnerships and a shift toward behavioral and operational readiness, moving beyond simple technical training to ensure performance and compliance.
-
Analytical Approaches For Quantifying Residual Host Cell DNA
5/29/2025
In this webinar, we’ll discuss the challenges, risks and considerations involved in developing and using in-house residual testing solutions, and the benefits of using commercial kits for residual DNA testing.
-
Why A Dynamic, Digital Defect Library Is Now A Regulatory Expectation
9/17/2025
Maintaining a dynamic, digital defect library is essential for modern sterile manufacturing. Learn how this approach helps ensure consistency in batch disposition and supports regulatory compliance.
-
Nitrosamines - New Requirements To Evaluate Contamination Risks
12/23/2024
Explore nitrosamine contamination, regulatory actions, and new evaluation requirements, featuring expert insights from Dr. Ulrich Reichert on prevention and risk assessment strategies.
-
Re-Engineering A Complex Process For FDA Compliance
8/21/2024
Discover the strategies that helped a company navigate a complex and shifting regulatory landscape to rapidly re-engineer a COVID-19 vaccine manufacturing process for FDA compliance.
-
The New Annex 1 Regulations – Why Is It Important And How Can We Help?
10/21/2024
The new Annex 1 regulations will significantly impact facilities and companies globally, requiring a comprehensive Contamination Control Strategy (CCS). Learn how to navigate these changes and ensure compliance.
-
Enhancing Biopharma ROI With In-House Long-Read Sequencing
1/29/2026
Long-read sequencing is redefining research by enabling clearer insights into complex genetic regions. Learn how this technology strengthens data confidence and accelerates modern R&D workflows.
-
The 5 Ws Of A Human Factors Strategy
3/31/2025
A human factors strategy ensures medical products are safe, effective, and compliant by integrating user-focused design early, reducing risks, and optimizing regulatory approval processes.
-
Verve Puts Digital-First Quality At The Heart Of Its QC Lab
1/21/2026
Learn how a biotech scaled faster by building a paperless lab, adopting cloud-based LIMS, and streamlining QA/QC processes to reduce errors, improve efficiency, and enable real-time collaboration.