news
Manufacturer retracts acquisition deal due to “data integrity issues”
According to Olympus Corporation, concerns about the non-vascular metallic stents were found post-closing following the agreed acquisition of Taewoong Medical Co., Ltd.
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Data integrity
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The role of GAMP 5, data integrity and QbD in pharmaceutical quality assurance
By ensuring accurate and reliable data in drug development, data integrity supports regulatory compliance and drug safety, a paper explains.
webinar
Enhancing biopharma workflows with the power of UV/Vis spectroscopy
8 March 2024 | By Thermo Fisher Scientific
Discover the valuable role ultraviolet-visible spectroscopy can play in quickly and accurately monitoring a drug as it moves through the research & development workflow and enabling quality and regulatory compliance through the manufacturing process.
news
Medical device manufacturers must remain “vigilant” to ensure data integrity of premarket submissions
With the integrity of a greater number of third-party-generated data called into question, the US Food and Drug Administration (FDA) is unable to rely on the data to grant marketing authorisation, the agency asserts.
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Implications of AI regulation for data integrity
According to research, organisations should invest in training for those working with artificial intelligence (AI) to support data integrity assurance in AI applications.
webinar
Are outdated microbial identification methods risking your product safety and operational efficiency?
9 February 2024 | By Charles River Laboratories
Watch this webinar to unravel the complexities of microbial identification technologies and their pivotal role in fortifying contamination control strategies within the pharmaceutical industry.
webinar
Mastering Pharma 4.0 validation challenges with technology
2 February 2024 | By Kneat Solutions
In this webinar Kneat Solutions’ Director of Consulting, Marcus Ryan, discusses the best way forward in the evolving world of Pharma 4.0™, revealing how companies can overcome validation complexities with technology.
whitepaper
ebook: Filling gaps in managing large volumes of biologics
Aseptic aliquotation and cryopreservation of bulk drug substances are crucial process steps in bioprocessing that require an efficient process.
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Pharma Horizons: Artificial Intelligence
EPR's inaugural Pharma Horizons report explores the latest advances in artificial intelligence (AI) and machine learning (ML) for drug development, pharmaceutical manufacturing and quality control.
video
Video: Unveiling the science behind NGS
Virtual seminar presented by Christine Farrance, PhD, Senior Global Scientific Affairs Liaison of Microbial Solutions at Charles River designed to improve your understanding of how to leverage NGS to analyze the entire genome and mixed samples in a single, efficient test to identify, classify, and understand microbes in mixed and…
article
Transforming pharmaceutical manufacturing: The AI revolution
The integration of artificial intelligence (AI) in pharmaceutical manufacturing is set to open a brand-new chapter in this industry's development, as well as unprecedented opportunities for strengthening quality control and improving decision-making. In this article, Dr Gonesh Chandra Saha, Head of the Department of Computer Science & Information Technology at…
news
Regulatory revision essential for bioprocess IIoT adoption
A limited number of Industrial Internet of Things (IIoT) applications exist in the bioprocessing industry and remain to be challenged in manufacturing operations, research has highlighted.
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European regulators prepare for AI in pharma
A coordinated workplan, which runs to 2028 will help European regulators embrace opportunities for artificial intelligence.
article
Nitrosamines analysis with LC/MS-MS
This ebook provides a comprehensive overview of nitrosamine analysis for the pharmaceutical industry.
news
‘Innovation-first’ mindset vital for advanced therapies sector future
Improving data harmonisation and investing in the advanced therapy sector’s workforce are some of the key recommendations the sector must take to advance the field and increase patient access, a new report highlights.
