Insights On Regulatory Compliance
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Cutting-Edge Automation Revolutionizing Cell Line Development
8/1/2023
Advancements in cell line development workflows have created the potential for greater standardization and automation, eliminating the most common workflow bottlenecks and improving reproducibility.
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Virus Filtration: Regulations And Mechanisms
7/25/2024
In this presentation, Dr. Nigel Jackson, Principal Engineer in R&D, offers an in-depth discussion on regulatory guidance and recent updates pertaining to virus filtration.
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Overcome 3 Key Challenges Facing Life Science Contract Manufacturers
6/2/2023
It has become clear that digitizing production processes is no longer optional for CMOs and CDMOs, but a necessity to keep up with the demand and competition in the pharmaceutical, biotechnology, and medical technology industries.
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Bioburden And EU GMP Annex 1: Risk Assessment, Reduction, And Testing
3/10/2023
Experts on regulation, filtration, sampling, and quality control discuss risk assessment and filtration-based strategies to reduce bioburden.
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The Role Of Change Management In Supporting Innovation In Pharma
10/29/2023
Learn in detail about the impact of change management on the pharmaceutical industry and how it ensures innovations and improvements are managed effectively.
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Technology Transfer Strategies: Fill-Finish Automation And Robotics
10/30/2023
Establishing early and clear tech transfer strategies is a key component of a holistic approach to drug development. Learn about the role that capable fill-finish solutions play in this process.
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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.
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Key Cleanroom Design Considerations For Drug Manufacturing
4/18/2023
Compare and contrast the pros and cons of several cleanroom design and construction methods to determine the most suitable approach for your specific project.
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Combat Major Cell And Gene Therapy Manufacturing Regulatory Obstacles
8/8/2023
As cell and gene therapies grow in the pharmaceutical industry, drug sponsors must determine how to successfully navigate evolving regulations, study design considerations, and a lack of animal models.
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Translating Study Reports – A GLP Draft Guidance
5/6/2024
The FDA has provided guidelines for the translation of studies conducted by non-US testing facilities, including an expectation that the translated report include a statement of certification requirements.