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.

• Demolishing Doubts About AI In Pharma

  The FDA and PDA's recent initiatives provide frameworks and guidance for integrating AI into pharmaceutical manufacturing, emphasizing innovation, and safety.

• EU GMP-Annex 1: Changes, Challenges, And Ready-To-Use Sterile Packaging

  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.

• Molecular Approaches To Streamline Cell Therapy Product Analytical Testing

  Learn how rapid molecular methods of cell therapy testing like qPCR for mycoplasma, sterility, and lentiviral quantification are key to accelerating product release and timely treatment delivery.

• The Future Of Compliance, Efficiency, And Data Integrity

  5/5/2025

  Explore how eValidation revolutionizes the pharmaceutical industry by enhancing compliance, efficiency, and data integrity, as well as its indispensable role in modernizing traditional validation methods.

• Navigating The Digital Frontier

  5/15/2024

  This panel discussion looks ahead at decentralized manufacturing, key regulatory considerations, and the anticipated future where cybersecurity becomes a paramount focus.

• Project Management: The Secret Weapon In Effective Tech Transfer

  5/23/2024

  Explore how a CMO with innovative practices and a successful approach to tech transfer and manufacturing processes can help meet project timelines and mitigate risk on the path to market.

• A Driving Force For Advanced Cleanroom Standards

  2/18/2025

  Navigating the inherent conflicts between GMP and biocontainment regulations is critical when designing specialized cleanrooms for advanced therapy manufacturing.

• Measuring And Monitoring Environmental Surface Residues

  4/1/2025

  Explore techniques like visual inspection and TOC sampling to assess surface residues as well as discover the benefits and challenges of these practical methods to achieve effective residue validation.