Reference Standard Management for Pharmaceutical Development

Life Sciences, Pharmaceutical Regulation, Pharmaceutical, Drug Discovery & Development,
  • Tuesday, January 09, 2024

Discover an informative webinar focused on maintaining regulatory compliance with a high-quality reference standard program for pharmaceutical development. Reference standards are a cornerstone of the pharmaceutical industry, critical to assessing product quality, safety and potency during development. Throughout the drug development process, properly characterized reference standards are required to ensure quality control in critical areas such as the release of new product batches and stability evaluation. This webinar is designed for industry professionals looking to gain a practical understanding of reference standards, from their acquisition and qualification to their application in maintaining product quality and regulatory compliance.

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A typical drug product may require a reference standard for not only the active pharmaceutical ingredient (API) but also for any number of degradation products, process impurities, metabolites or resolution components. For new drugs where compendial standards are unavailable, it is the responsibility of the sponsor to synthesize and characterize these materials. The featured speakers will delve into the analytical testing necessary for the qualification of these different standard types, with a focus on industry guidelines such as The Food and Drug Administration’s (FDA) current good manufacturing practices (cGMP) and the International Council for Harmonisation (ICH).

Reference standards are required for a wide range of development activities that impact clinical research, including manufacturing, stability testing and toxicology. With an increased reliance on both domestic and international contract laboratories to perform critical research functions, storage and distribution of standards to collaborating organizations have become more critical than ever. Failure to properly characterize reference standards and maintain them in a qualified state can lead to significant delays in project timelines and increased costs.

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This webinar will provide attendees with essential insights into the qualification and distribution of reference standards, and the importance of developing a formal program for reference standard management.

Join this webinar to gain the knowledge needed to maintain regulatory compliance by developing a high-quality reference standard program to support the entire pharmaceutical development process.

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Speakers

John Cobb, MRIGlobal

John Cobb, Program Manager, MRIGlobal

John Cobb is a Program Manager with MRIGlobal, responsible for technical and scientific oversight of multidisciplinary projects. With 14 years of experience in analytical chemistry and repository management in the pharmaceutical industry, he has initiated and managed multiple reference standard management programs to support client’s drug development goals.

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Audrey Ingram, MRIGlobal

Audrey Ingram, PhD, Senior Chemist, MRIGlobal

Dr. Audrey Ingram is a Senior Chemist with MRIGlobal, responsible for technical and scientific oversight of analytical chemistry projects. With nearly a decade of experience in analytical chemistry in the pharmaceutical industry, she specializes in analytical chemistry techniques, analysis of small molecules and peptides, and cGMP regulatory compliance.

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Who Should Attend?

This webinar will appeal to Managers/Senior Managers/Directors/Specialists in the following fields:

  • Analytical development/analytical chemistry
  • CMC
  • Regulatory affairs CMC
  • Quality assurance/quality control

What You Will Learn

Attendees will gain insights into:

  • The acquisition and qualification of reference standards for new drugs
  • The challenges in reference standard management and strategies to mitigate them
  • The critical role of reference standards in product quality and project timelines
  • Best practices for the storage and distribution of reference standards to collaborators and vendors
  • The importance of a comprehensive reference standard management program in supporting key aspects of pharmaceutical development

Xtalks Partner

MRI Global logo

MRIGlobal

MRIGlobal improves the health and safety of people everywhere by addressing some of the world’s greatest threats and complex biological, chemical, and engineering challenges. Founded in 1944 as an independent, not-for-profit organization, MRIGlobal provides customized research and development services to health and defense-focused organizations in need of innovative and multidisciplinary solutions. This includes expertise in clinical research support, infectious disease and biological threat agent detection, global biological engagement, in vitro diagnostics, and laboratory management and operations. To learn more, visit mriglobal.org.

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