INSIGHTS ON REGULATORY COMPLIANCE

• Meeting Annex 1: A Proactive Approach To Regulatory Compliance

  It was imperative for a large European CMO producing multiple biologics to select the right product quality and value for each customer to comply with the August 2023 EU GMP Annex 1 revision.

• FAQs On The Revised EU GMP Annex 1: Volume 2

  Review the implementation of a holistic Contamination Control Strategy (CCS). Discover four key considerations for assessing component readiness: product, process, protection, and proof.

• Process Liquids And Buffers Offering

  Whether you are a researcher, scientist, or industry professional, this video will provide valuable insights into our large volume liquids manufacturing capabilities.

• Optimizing Process Loads For VHP Decontamination

  Explore how CAI helped a company rescue a failing CQV project and create more efficient Vaporized Hydrogen Peroxide Material Air Lock (VHP MAL) Loads to enhance operational efficiency.

• Analytical Approaches For Quantifying Residual Host Cell DNA

  5/29/2025

  In this webinar, we’ll discuss the challenges, risks and considerations involved in developing and using in-house residual testing solutions, and the benefits of using commercial kits for residual DNA testing.

• Take Action On PFAS To Protect Your Critical Processes

  9/18/2025

  PFAS restrictions are tightening, but a full ban could disrupt critical industries lacking alternatives, such as pharmaceutical manufacturing. Learn where PFAS use remains indispensable.

• The Impact Of Artificial Intelligence On CQV

  7/23/2025

  AI is revolutionizing CQV in life sciences by automating documentation, enabling real-time monitoring, and driving predictive quality to boost efficiency and compliance across validation processes.

• The New Annex 1 Regulations – Why Is It Important And How Can We Help?

  10/21/2024

  The new Annex 1 regulations will significantly impact facilities and companies globally, requiring a comprehensive Contamination Control Strategy (CCS). Learn how to navigate these changes and ensure compliance.

• MilliporeSigma's 97-Day Implementation Success Story

  3/19/2025

  Read how MilliporeSigma transformed validation processes with a digital validation system to achieve compliance in just 97 days, as well as learn key takeaways from their swift transition.