Regulatory

1. A Practical Road Map For Compliance To EU GMP Annex 1

   Learn how to interpret the Annex 1 container closure requirements, develop deterministic analytical methods for CCIT, and design packaging studies that generate robust data demonstrating good CCI.

2. Navigating GxP Compliance Challenges 10/30/2024

   Learn how to select and manage trusted software suppliers to streamline your digital transformation, mitigate risks, and ensure regulatory adherence. Watch to discover best practices and real-world examples.

3. Human Factors Testing: Engaging End-Users In Med Device Development 3/11/2025

   Explore the significance of human factors in the development of medical devices through an illustration of how important it is to incorporate the end users in the device development process.

4. Survival Kit For Quality Regulations: A Closer Look At Lyo Packaging

   Explore primary packaging developed following well-established ICH principles for sustainable compliance and vial container closure systems for product development and commercial manufacturing needs.

5. Combination Products: Navigating Regulatory Strategy, Design Verification 5/19/2025

   Delve into the intricacies of combination products and the regulatory expectations, including risk-based determination, evaluation, and documentation approaches for performance requirements.

6. Your Contract Manufacturer Partner 12/14/2020

   Discover an integrated solution for pharmaceutical companies that offers a broad range of manufacturing services and capabilities to produce high-quality devices.

7. Strategies For Startups — How To Structure Milestones For Successful Outcomes 5/3/2021

   Experts from the cell and gene therapy field share their experiences and discuss trends to accelerate therapies from the bench to the bedside, with specific focus on strategies for start-ups, how to look at robust scale-up, and reducing CMC risk.

8. Managing Risks In Injectable Drug Delivery 3/13/2025

   Gain insights pertinent to efficient and effective drug development. Understand and execute a risked-based critical thinking approach related to injectable drug packaging and delivery.

9. EU Med Device Regulations: Ensuring Compliance For Integral Combination Products

   Review the EU Medical Device Regulation (MDR) changes, specifically with respect to integral combination products, and examine the technical documentation packages supporting functionality and content.

10. Bioburden And EU GMP Annex 1: Risk Assessment, Reduction, And Testing

    Experts on regulation, filtration, sampling, and quality control discuss risk assessment and filtration-based strategies to reduce bioburden.