Regulatory

1. 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.

2. Attracting The Right Capital — Forming Partnerships For Long-Term Success 5/3/2021

   Experts share their experiences on investing in the cell and gene therapy field and how to form long-term partnerships for companies on the path towards bringing a potentially life-changing therapy to patients.

3. Selecting Container Closure Components: Extractables And Leachables

   Primary packaging components require a thorough assessment to ensure safety and efficacy. Plan ahead and start your assessment early to mitigate your risks, delays, and out-of-pocket costs.

4. 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.

5. Key Considerations When Developing Your Combination Product 2/20/2024

   Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.

6. 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.

7. 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.

8. Faciliflex Cleanroom Module For Therapeutic Drug Manufacturing 1/4/2021

   The Faciliflex Module is a transformational new concept in designing cleanrooms for the production of lifesaving therapeutics.

9. The Impact Of Water Activity Testing On Tablets And Capsules

   Watch to gain a comprehensive understanding of water activity testing as well as how to effectively use non-destructive headspace analysis to generate dependable water activity data.

10. 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.