Insights On Quality Control
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5 Steps To Pass Your ISO 9001 Audit
5/18/2023
Reduce your pre-audit stress and pave the way to successfully meeting ISO 9001 standards and becoming certified.
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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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Microbial Sampling Of Compressed Gas Has Never Been So Simple And Safe
4/3/2023
Discover the key features of the innovative MAS-100 Atmos® system, designed for the user's peace of mind, ease of use, maximum safety, and full regulatory compliance.
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Biological Indicators - Identification And Purification
10/7/2022
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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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 Route To Faster Microbial Quality Control
6/7/2023
Join product and application experts Anne-Grit Klees, Carine Krebs, and Esther Welterlin to discover the benefits of using the new rapid microbial detection platform, Milliflex® Rapid System 2.0.
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Key Pillar Of A Successful CDMO: Exceptional Regulatory Compliance
10/18/2023
Ensuring regulatory compliance is paramount for a CDMO to meet manufacturing standards, warrant patient safety, and maintain its reputation.
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Modernizing Compendial SEC Methods For Biotherapeutics
4/16/2024
Explore the advantages of a bio-inert HPLC system through the migration and modernization of a compendial SEC method outlined in the United States Pharmacopeia (USP) General Chapter <129>.
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Embracing And Implementing Computer Software Assurance Guidance
5/18/2023
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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Detecting Drug-Excipient Incompatibility In Pharmaceuticals
5/5/2023
Here, we focus on how the apparent melting approach can provide a rapid screening protocol for the detection and analysis of drug-excipient incompatibility in mixtures and formulas.