Insights On Regulatory Compliance
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Implementing A Risk-Based Approach To Calibration
2/20/2024
Discover why companies may benefit from a risk-based approach to calibration, utilizing information from User Requirement Specifications and other documents created during process development.
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Do You Have an FDA Audit Process in Place?
2/23/2023
Ease the stress of a U.S. Food and Drug Administration (FDA) visit to your facility by learning how to maintain a state of FDA audit process readiness.
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6 Best Practices For Enterprise Quality Management Solutions Implementation
9/8/2022
While all enterprise software implementations are unique we share six best practices that will improve the likelihood of any successful quality management software implementation project.
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5 Steps To Better Supplier Quality Audits In Drug Manufacturing
3/24/2023
Explore four legitimate reasons to conduct a supplier audit and five steps to achieve a better supplier quality audit.
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A New Framework For Identifying Nitrosamine Risks And Efficiently Derisking Products
6/18/2024
Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.
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Maximizing ROI: Extracting Value From Analysis And Reporting
7/3/2024
How can organizations establish the foundation for advanced analytics, AI and ML, in pursuit of a robust and adaptive lab of the future?
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Project Management: The Secret Weapon In Effective Tech Transfer
5/23/2024
Explore how a CMO with innovative practices and a successful approach to tech transfer and manufacturing processes can help meet project timelines and mitigate risk on the path to market.
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Innovative Analytical Strategies To Address Common Development Challenges
4/30/2024
Discover analytical strategies designed to address challenges occurring during development of new molecular formats such as chain assembly, multiple-MoAs, and diverse post-translational modifications.
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Tips For Viral Vector Production
4/16/2024
Learn about how meticulous purification optimization can maximize recovery and impurity removal by leveraging scalable downstream technologies to meet regulatory and process economy requirements.
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EU GMP Annex 1 – Navigating The Road To A Successful Annex 1 Inspection
7/17/2024
The complexities of EU GMP Annex 1 inspections can be challenging. At an event hosted by NIBRT and Cencora PharmaLex, industry experts shared key insights and best practices for ensuring compliance.