Using Phase Appropriate Analytical Method Validation in Drug Development

Commercialization & HEOR, Drug Discovery & Development, Life Sciences,
  • Tuesday, April 30, 2019

The fast contemporary pace associated with drug development presents many challenges including speed, accuracy and compliance, all while maintaining activities within a limited budget. The introduction of a new drug product through formulation and manufacturing requires a level of analytical accuracy appropriate for the phase of the drug product, often times less stringent than that required for later phases and commercial products. The challenges facing organizations today include the decision processes associated with limiting risk, linking the early-phase activities to late-phase activities and establishing accurate analytical measurements of various drug product forms upon which organizational decisions are made. In this live webinar, the speaker will discuss the various options available to the pharmaceutical industry, and the design of experiments associated with Phase Appropriate Analytical Method Validation, saving time and resources as drug products approach commercialization.

Speaker

Adam C. Fox, Sr. VP Analytical Operations, Nitto Avecia Pharma Services, Inc.

Adam Fox has over 28 years of pharmaceutical, biopharmaceutical, and medical device industry experience. Prior to Nitto Avecia Pharma Services Adam was the Senior Director Quality Control & Microbiology for Teva Parenteral Medicines, Inc.  In this role he led and directed quality and compliance initiatives throughout the organization; to include metrics, process mapping, process improvement, process implementation including SOP generation and accompanying training, and Quality Council and Material Review Board.  Improved market presence through driving new technologies development, particularly in the areas of raw materials, validation, verification and remediation.

He was chosen as an international delegate within the BI Organization; represented the US for stability programs to be implemented in support of the markets in which BI supplied product; extensive assignments in Germany, Mexico, and across the US.

As an established speaker, he has chaired and presented at various industry conferences including Recent Advances in analytical method development, society for Industrial Microbiology and Biotechnology, Biotechnology Industry Organization, and International Society for Pharmaceuticals.  He has written and contributed to numerous white papers on topics including product quality assessments. Previous to Teva, Adam served as Manager Quality Control for Boehringer Ingelheim, Inc. Adam holds a B.S. Microbiology & Chemistry from The Ohio State University and B.S. in Pharmacy from Ohio Northern University. He currently resides in Laguna Niguel, CA.

Message Presenter

Who Should Attend?

This webinar will appeal to individuals working within the following or related departments: 

  • Phase Appropriate Analytical Method Validation
  • Analytical Development
  • Technical Services
  • Validation

What You Will Learn

Attendees will gain insights on: 

  • An overview of analytical operations challenges 
  • Designing analytics appropriate to various phases of testing
  • Best practices for linking early-phase activities with late-phase activities 
  • How analytical method validation saves time and resources during drug development

Xtalks Partner

Nitto Avecia Pharma Services

Nitto Avecia Pharma Services is your single solution for premier contract development and manufacturing services. Nitto Avecia Pharma Services supports the pharmaceutical, biopharmaceutical, and medical device industries with a complete package of CGMP services (small to large molecules) including:

  • Formulation/process development
  • Parenteral manufacturing (liquid/lyo)
  • Analytical development
  • Analytical chemistry
  • Stability
  • Structural chemistry
  • Microbiology
  • drug delivery device testing

With three state-of-the-art facilities located on one campus in Irvine, California, Nitto Avecia Pharma Services’ experienced staff and robust quality infrastructure delivers client-centric solutions for early phase through post-market life cycle management. We invite you to visit us, audit our facilities, discover our insight, and learn more about our commitment to excellence. Learn more at www.aveciapharma.com or call (949) 951-4425.

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