Insights On Regulatory Compliance
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How Crucial Is Culture Media Selection In Environmental Monitoring?
6/20/2023
Explore culture media regulatory requirements, the impact of manufacturing guidelines and media features and specifications on environmental monitoring, and the importance of media supplier selection.
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US GMP (21 CFR 820) Manufactured Oligos For Preclinical Research
10/18/2023
Learn why Custom cGMP Oligos should be considered to ensure oligo products meet the strict standards of MDx, LDTs, and preclinical research.
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Reaching BLA Success: Fast-Track Approach To Process Characterization
11/30/2023
Discover how knowledge of microbial processes and process characterization understanding can be used to design targeted BLA programs while managing risks.
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Eliminating Data Integrity Errors Through Digitization
10/17/2022
Explore the urgent need for businesses to adopt strong data integrity practices and identifies measures for how to achieve and sustain compliance.
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The Synergistic Role Of Drug Safety In Clinical Trial Operations
4/25/2024
Delve into the significance of adept interpersonal leadership within your drug safety program, shedding light on the operational and financial benefits that stem from fostering a collaborative environment.
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Navigating The Digital Frontier
5/15/2024
This panel discussion looks ahead at decentralized manufacturing, key regulatory considerations, and the anticipated future where cybersecurity becomes a paramount focus.
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Developing Injectable Drug Placebo Formulations For Clinical Trials
1/9/2024
Developing a placebo for an injectable drug requires consideration of the formulation’s impact in trials, chemistry and physical details, ethical concerns, and regulatory compliance.
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EU GMP Annex 1: Impact On Cleaning And Disinfection
3/30/2023
Explore the most recent rewrite of the EU Annex 1 document as well as the contamination control strategy outlined within.
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Vigilance Guidance Provides Greater Clarity On MDR Requirements
6/12/2024
Explore how new vigilance guidance under MDR clarifies reporting obligations for high-risk medical devices, ensuring enhanced safety oversight and compliance amid stricter regulations.
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Impact Of Water Activity On The Potency, Purity And Bioavailability Of Oral Solid Dosage Products
11/21/2022
Explore laser-based headspace analysis, the impact of USP<922> Water Activity on primary packing selection, and the impact of water activity on the potency, purity, and bioavailability of OSD products.