Insights On Regulatory Compliance
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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.
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6 Steps To Simplify Software Validation
10/4/2022
Six steps to reducing the time, pain, and expense of the software validation process while maintaining quality and safety.
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Revolutionizing Drug Manufacturing: A Closer Look At GMP Inspections
12/20/2023
Learn about the collaborative efforts among global regulators currently underway to address drug availability challenges following the supply shortages and disruptions from the COVID-19 pandemic.
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Shifting The Approach: 4 Strategies For ICH E6(R3) Implementation
4/30/2024
In addition to codifying some best practices, R3 suggests sponsors take a proportionate approach to identifying and managing areas of risk.
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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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A Guide To Writing Effective SOPs In Life Sciences
8/17/2022
We share some SOP guidelines that can help you build and manage documents that are easily accessible, relevant, and something your team can consistently rely upon.
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Reflecting Again On GMP Requirements For Marketing Authorization Holder
12/20/2023
Learn in detail about Annex 16, the responsibilities of Marketing Authorization Holders (MAHs), and a practical way for MAHs to implement their responsibilities with their contract manufacturers.
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An Introduction To Laminar Airflow Technology In Aseptic Processing
8/21/2023
Explore the vital role that laminar airflow technology plays in meeting sterile integrity standards and minimizing contamination risks in pharmaceutical cleanrooms.
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The No. 1 Most Common Problem In FDA GMP Inspections
6/20/2022
With issues involving quality responsibilities and procedures at the top of the FDA warning list, we uncover where the solution to make this problem a thing of the past.
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4 Essential Components Of An Audit Management System For Life Sciences
11/15/2022
The COVID-19 pandemic has changed audits and inspections. To combat these challenges, companies need to adopt an electronic quality management system that covers every aspect of audits and inspections.