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LIVE WEBINAR

Accelerating Product Release Through Patent-Pending RapidCert™ Biological Indicator (BI) Sterility Testing

December 4, 2025

1:00 pm ET

Nina Moreno and Jordan Elder

RapidCert™ BI testing offers a transformative approach to biological indicator testing, delivering faster results than traditional compendial methods—incubation time is reduced to 48 hours—while upholding product quality and patient safety. This presentation will outline how the RapidCert™ BI test meets regulatory expectations for alternative microbiological methods and will highlight its key benefits, including reduced time to result, enhanced process control, and improved decision-making.

Key learnings:

  1. How RapidCert™ BI testing complies with expectations for an alternative method
  2. Key benefits of RapidCert™ BI testing vs. the compendial method
  3. Regulatory approach for implementing RapidCert™ BI testing
Nina Moreno

Nina Moreno

MBA, SM (NRCM)
Sterility Assurance Expert

Nina Moreno is a certified microbiologist and Global Segment Director for Sterility Assurance at Nelson Labs. She has been with the company for over 20 years and has experience in providing technical and strategic oversight for microbiological laboratories.   She is a member of the Kilmer Microbiological Quality Process Analytical Technology team (MQPAT) and the...

Jordan Elder

Jordan Elder

Regulatory Affairs Expert

Jordan has 15 years of experience navigating regulatory pathways and identifying optimal regulatory strategies for pharmaceutical and medical device companies. As Director of Regulatory Affairs for Regulatory Compliance Associates (RCA) he is responsible for providing clients with general direction, tactical objectives, and functional plans for their regulatory needs. Jordan is a meticulous regulatory professional with...