Insights On Regulatory Compliance

1. Compliance: Framing Success Utilizing PIC/S And EU GMP 12/20/2023

   Explore the differences between the Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP Guide and the EU GMP Guides, and gain insight into the teamwork between the FDA, MHRA, and PIC/S.

2. Quality Roundtable: Optimizing Biologics Manufacturing Processes With Raw Materials 1/24/2024

   Improve your commercial manufacturing process with advice from regulatory and raw materials experts on the development journey from pre-clinical to licensure.

3. 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.

4. 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.

5. EU GMP-Annex 1: Changes, Challenges, And Ready-To-Use Sterile Packaging 8/27/2024

   Leveraging a pre-sterilized containment solution that meets the requirements of Annex 1 and outsources non-core activities can help prevent contamination and reduce the effort and liability of the CCS.

6. Tips For Viral Vector Production 4/16/2024

   Learn about how meticulous purification optimization can maximize recovery and impurity removal by leveraging scalable downstream technologies to meet regulatory and process economy requirements.

7. 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.

8. FDA's Advanced Manufacturing Technology Program 5/6/2024

   Learn about a new Advanced Manufacturing Technologies (AMT) Designation program aimed at accelerating the implementation of technologies that drive speed to patient and enhanced sustainability.

9. 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.

10. 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.