Insights On Regulatory Compliance
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Assess Your Digital Pharmaceutical Manufacturing Maturity
5/18/2023
Learn how regulated product manufacturers are meeting the demand for faster development and delivery of products to patients and where your operations fit in the digital maturity manufacturing model.
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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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Environmental Monitoring Vs. Good Aseptic Technique
4/23/2024
Review the standards and regulations promoting a cohesive environmental program, and explore manual compounding in laminar flow hoods, through to filling lines, in both open and closed systems.
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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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The Role Of FDA Predicate Rules In 21 CFR Part 11 Compliance
7/8/2022
Explore the relationship between FDA predicate rules and GMP, GLP, GCP, or other requirements applicable to your organization.
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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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The Impact Of Water Activity Testing On Tablets And Capsules
11/21/2023
Watch to gain a comprehensive understanding of water activity testing as well as how to effectively use non-destructive headspace analysis to generate dependable water activity data.
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The Future Of The FDA: Operating In An “Electronic World”
7/6/2022
Explore the FDA's e-transformation that promises to usher in a new era of electronic interactions between the agency and its constituents.
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Regulatory Convergence With Aurion Biotech
5/18/2022
Advanced therapeutics are as complex as they are promising. Establishing a global regulatory strategy for these modalities requires a comprehensive, multifaceted approach.
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FDA Remote Inspections Guidance
2/8/2023
Since the COVID-19 pandemic first hit, remote audits and inspections have been essential. Learn about remote audits and inspections and how audit management software can make the process easier.