INSIGHTS ON REGULATORY COMPLIANCE

• Integrated Annex 1 Compliance

  Learn about the critical changes in the Annex 1 guidance from a process equipment provider's perspective, several areas where process and product change could take place, and more.

• Modernizing Compendial SEC Methods For Biotherapeutics

  Explore the advantages of a bio-inert HPLC system through the migration and modernization of a compendial SEC method outlined in the United States Pharmacopeia (USP) General Chapter <129>.

• How To Prepare For An Inspection: 8 Tips For Success

  To achieve a successful inspection, organizations should adopt best practices. Examine these eight invaluable tools for inspection success.

• Cleaning And Disinfection Protocols For Annex 1

  The new GMP regulations coming out of the European Union will have a big impact on pharmaceutical manufacturers. Learn about executing a CSS, cleaning, disinfection, and much more.

• What is a CDMO?

  6/1/2023

  As you bring a new drug product to market, leveraging the expertise and technical capabilities of a CDMO can help reduce costs and streamline processes on the path to commercialization.

• Lessons Learned From Implementing FDA CSA Guidance

  2/20/2024

  Explore how some drug manufacturers are using the latest Computer Software Assurance (CSA) guidance to reduce effort and cost and the bumps you may hit along the way.

• Genome Integrity Analysis Of Adeno-Associated Viruses (AAVs)

  11/8/2022

  Learn about how RNA 9000 Purity & Integrity kit with ssRNA ladder allows for the assessment of genome size and purity of AAV regardless of the serotype.

• Approaching High Resolution AAV Analysis On A Single CE Platform

  11/8/2022

  Explore the results of a high-throughput multiple CQA analysis of AAV using the same samples on a single platform within one day.

• Applying Quality System Regulation (QSR) Best Practices To Improve Regulatory Compliance

  9/20/2022

  QSR compliance can be complex, but it doesn’t have to be burdensome. Implementing these best practices will improve your regulatory compliance while producing a product ready for market.