Insights On Regulatory Compliance

1. Master The 2-Point Calibration Process To Maintain Data Integrity 5/19/2025

   Ensure accurate sensor readings with an innovative software by mastering the 2-point calibration process. Learn more about how and why regular calibration supports data integrity and compliance.

2. The Role Of PUPSIT In A Contamination Control Strategy 7/25/2023

   Here, we discuss the relationship between the CCS and PUPSIT, highlight the role of sterilizing grade filtration in the control strategy, and talk about how this can change throughout the product life cycle.

3. Navigating The Digital Frontier 5/15/2024

   This panel discussion looks ahead at decentralized manufacturing, key regulatory considerations, and the anticipated future where cybersecurity becomes a paramount focus.

4. Compliance Audits: 4 Solutions To Avoid Failure 9/20/2024

   Although inspection and audit processes have evolved, you can still effectively navigate and manage them within your organization. Explore four solutions to address audit and inspection pain points.

5. Accelerate And Enhance Biomanufacturing Operator Training 5/28/2025

   Unlock the power of blended operator training and learn how combining digital tools with hands-on instruction reduces errors, boosts retention, and empowers your workforce for real-world production success.

6. Reaching BLA Success: Fast-Track Approach To Process Characterization 11/30/2023

   Discover how knowledge of microbial processes and process characterization understanding can be used to design targeted BLA programs while managing risks.

7. Biomanufacturing Readiness: A Validation Model For Multiproduct Facilities 6/12/2025

   Optimize your validation strategy to meet evolving regulatory demands and product complexities with a scalable, efficient framework that accelerates facility readiness and ensures consistent quality.

8. Vigilance Guidance Provides Greater Clarity On MDR Requirements 6/12/2024

   Explore how new vigilance guidance under MDR clarifies reporting obligations for high-risk medical devices, ensuring enhanced safety oversight and compliance amid stricter regulations.

9. EMA's Concept Paper On Confirmatory Clinical Studies A Welcome Step For Industry 6/12/2024

   Explore the implications of the European Medicines Agency's Concept Paper, its potential impact on biosimilar developers, and the broader implications for the pharmaceutical industry.

10. Preparing The PMS: A Commercial And Regulatory Imperative 7/17/2024

    Learn how proactive engagement with the Product Management Service (PMS) can pave the way for enhanced decision-making, operational agility, and sustained competitiveness in the pharmaceutical industry.