ProPharma Quality & Compliance
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Key Considerations For A Successful Launch In Nordic Markets
12/10/2024
Explore these key considerations to improve your market access when launching a pharmaceutical product and navigating the regulatory landscape in the Nordic region.
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Diary Of Compliance: A Year In The Life Of Ensuring FDA CAPA Standards
12/3/2024
Acme Pharma’s journey toward FDA CAPA compliance illustrates the intricate process of aligning with stringent regulations. Learn about the progress in documentation, corrective actions, and employee engagement.
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What Is GxP Compliance: A Detective's Guide To Quality And Regulatory Compliance
12/3/2024
Learn about GxP compliance and how it requires a culture of vigilance, robust quality management systems, continuous staff training, and collaboration with regulatory experts.
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EU Pharmaceutical Legislation Revisions
12/3/2024
The EU pharmaceutical legislation aims to balance public health priorities with industry growth, shaping a more sustainable and innovative pharmaceutical landscape in Europe.
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Building Clinical Quality Assurance
11/27/2024
Navigating the intricate clinical development process necessitates a robust Clinical & Development Quality Assurance Department to ensure adherence to health authority regulations.
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Staying GMP Compliant: A Consultant's Guide To Compliance Bliss
11/12/2024
GMP compliance ensures quality and safety in pharmaceutical manufacturing through regular assessments and continuous improvement, helping to prevent risks and keep processes efficient.
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Ensuring Quality In Clinical-Phase Drug Manufacturing: A Comprehensive Guide
11/12/2024
Quality Assurance (QA) ensures consistency and reliability in early-phase, small-batch production, fostering compliance through leadership support, collaboration, and continuous improvement.
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15 Days Of Panic: You Received FDA Form 483 Warning Letter, Now What?
11/6/2024
Receiving an FDA 483 is serious but manageable. Learn more about support from medical manufacturers with compliance, response preparation, and corrective action to prevent escalation to Warning Letters.
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Agile Use In Non-Software Project
10/28/2024
Agile methodology, initially for software development, is now valuable for pharmaceutical and medical device projects, enhancing flexibility, stakeholder satisfaction, and adapting to non-software needs.
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Compliance Auditing: Diving Into Common Critical Findings
10/28/2024
Review critical findings in compliance audits, highlighting frequent issues, their impact on operations, and steps companies can take to improve regulatory compliance.