Insights On Regulatory Compliance
-
The Role Of The Technical Transfer Executive Sponsor
10/30/2023
Explore the importance of understanding a CDMO’s flexibility and culture, models and scale of equipment, technical capabilities, regulatory support, quality system, and executive sponsorship model.
-
4 Digital Transformation Gaps In Pharmaceutical Manufacturing
3/30/2023
Take an in-depth look at the pitfalls of manual, paper-based manufacturing processes and why digitization could be the answer for pharma and medtech manufacturing of the future.
-
Analyzing COVID-19 Vaccine Purity Using LC-MS Technologies
11/8/2022
Explore why process-related impurities are a concern in vaccines and present results and learnings from LC-MS analyses of several mRNA- and protein-based vaccines for COVID-19.
-
Key Takeaways From The ISPE Ireland Annex 1 Event
4/12/2024
Key insights from the ISPE Ireland Annex 1 Event shed light on challenges and solutions in meeting EU GMP guidelines for sterile medicinal products.
-
Pharmaceutical Solid-State Studies
4/9/2024
Solid-state characterization meticulously analyzes the physical properties of a drug in its solid form. Understand how this analysis is integrated throughout the drug development lifecycle.
-
Biological Indicators - Identification And Purification
10/7/2022
In this session, an expert walks you through the purity testing process and explains identification methods for biological indicators to help end users.
-
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.
-
Achieving Next-Level Quality With Digital Technology In Manufacturing
9/30/2022
Learn how a modern Manufacturing Execution System (MES) is using digital production records to help manufacturers regulated by the FDA improve their quality and efficiency goals.
-
Improving Quality Through Supplier Audits
6/6/2022
Suppliers and manufacturers working together to improve quality throughout the supply chain creates high quality standards to ensure final products are safe and effective.
-
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.