Geraldine Carr-Mulry

Sep 11, 2024 | cellandgene.com | Tyler Menichiello |Parrish Galliher |Brian Hubbard |Geraldine Carr-Mulry

Data Integrity And ComplianceDiscover why data integrity is crucial for compliance in the pharmaceutical and biotechnology industries. Data integrity issues, often due to incomplete data, are a leading cause of FDA warning letters, putting your operations at risk of recalls and shutdowns. Learn how to safeguard your lab by ensuring reliable electronic records and proper software validation.

Aug 10, 2024 | pharmaceuticalonline.com | Tim Sandle |John W.M. Claud |Mark Witcher |Geraldine Carr-Mulry

JULY'S BEST FEATURED EDITORIALChatGPT-4: Practical Applications For The Biopharma LaboratoryAI has made its way into the biopharma laboratory, and ChatGPT-4 is the most popular. Do you know the capabilities that this tech can deliver? Making Good Decisions When FDA Investigators Come KnockingReady or not, when the FDA inspector arrives, the test has already started. New final guidance makes clear what the agency considers an attempt to stonewall.

May 6, 2024 | pharmaceuticalonline.com | Geraldine Carr-Mulry

By Geraldine Carr-Mulry, Quality and Regulatory Consultant Annex 21 details the GMP requirements specified for human, investigational, and/or veterinary medicinal products imported to the European Union and European Economic Area (EEA) by holders of a Manufacturing Import Authorization (MIA). It is possible that the implementation of Annex 21, which aims to establish a robust compliance system, has inadvertently created additional barriers to supply that were not anticipated.

Apr 25, 2024 | bioprocessonline.com | Irwin Hirsh |Q-Specialists AB |Matthew Pillar |Geraldine Carr-Mulry

Webinar: Addressing The Options And Challenges In Subvisible Particulate Contamination Monitoring In Single UseJoin us for a webinar on May 16th with Entegris! Particulate contamination in pharmaceutical and biopharmaceutical products produced using single-use systems can create detrimental health risks that are required to be minimized by regulatory agencies. This contamination can be divided into visible and subvisible ranges, both ranges of particles are tested using different techniques.

Apr 25, 2024 | cellandgene.com | Geraldine Carr-Mulry |Marwan Alsarraj

Webinar: Continuously improving Quality and Efficiency in AAV ManufacturingIn this webinar you'll learn how to accelerate timelines while increasing quality aspects in AAV manufacturing as well as the benefits of IDT Biologika's AAV capabilities and platform approach. Make sure to tune in on May 16th for an outlook for upcoming technologies and evaluation from a GMP manufacturer perspective. Click here to learn more.