INSIGHTS ON QUALITY ASSURANCE
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Embracing And Implementing Computer Software Assurance Guidance
Pharmaceutical manufacturers are exploring comprehensive computer software assurance (CSA) approaches, the benefits of implementing a risk-based framework, when to apply it, and the first steps to this CSA approach.
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ISO/DTR 14644 -21 Cleanrooms And Associated Controlled Environments
Here, we review the Technical Report outlining how particle counters are used to classify and monitor cleanroom performance, ensuring it meets required standards under normal operating conditions.
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The Problems With Construction Quality In Life Sciences
In the mission-critical construction industry, quality management is underperforming. Understand the importance of quality control in life sciences commissioning processes and construction programs.
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Insights And Strategies For GMP Manufacturing Of RNA-Lipid Nanoparticles
The emergence of RNA-encapsulated-lipid nanoparticles has introduced a seismic shift in biopharma innovation. But how will the industry adapt to diversifying applications and scales going forward?
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Avoiding Project Risks When Building ATMP Facilities8/16/2022
What are five factors that can mark the difference between success and failure of your ATMP project?
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Biological Indicators - Identification And Purification10/7/2022
In this session, an expert walks you through the purity testing process and explains identification methods for biological indicators to help end users.
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Overcoming Hurdles With A Contamination Control Strategy7/26/2024
Learn about the importance of a facility-specific CCS, explore common hurdles encountered in its development and get practical advice on creating a robust and compliant strategy.
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Time Is Money: The Hidden Cost Of Inefficient Laboratory Practices1/10/2023
Explore the main inventory management challenges faced by fast-paced biotech and pharmaceutical laboratories and how they directly impact research outcomes, costs, and regulatory compliance.
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Best Practices In Commissioning And Qualification7/5/2024
An integrated approach to C&Q ensures coordination and synchronization between commissioning and qualification activities, enhancing both regulatory compliance and product safety.
QUALITY ASSURANCE SOLUTIONS
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The out-of-specification (OOS) product in the MasterControl Quality Management System (QMS) allows for seamless compliance.
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Observe the viability of your cells with the field-upgradeable cellular imaging option for the SpectraMax i3/i3x Multi-mode Detection Platform.
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TrackWise® is the world’s leading on-premises QMS software. It brings all your quality processes together in a single place to give you the big picture of your compliance and operational effectiveness.
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Explore the many ways inSeption Group is working to grow and improve their client’s departments and companies as a whole.
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Discover how inSeption Group distinguishes the right people as the most impactful variable of any outsourcing equation and contributes to the delivery of life-changing therapies.