Regulatory
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Compressed Gas Risk Assessment: A Significant Step In Your CCS
10/10/2024
Discover the importance of compressed gas monitoring in ensuring product quality and compliance with EU GMP standards.
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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.
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Navigating Special Regulatory Pathways For Advanced Therapy Development Success
6/12/2025
Don't let regulatory hurdles slow you down. Learn from leading experts about special designations like RMAT and PRIME to accelerate your advanced therapy development and ensure success.
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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.
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Importance Of Architectural Layout To Prevent Contamination
8/21/2025
In this segment from the Pharmaceutical Online Live event, “Contamination Control Strategies For Drug Manufacturers,” panelists discuss the importance of unidirectional flow for preventing contamination, as well as specific architectural requirements related to the European Union's Annex 1 regulations. Poor or aging facility design is not an acceptable excuse for noncompliance.
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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.
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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.
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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.
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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.
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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.