Brilliant science is required to identify potential therapeutics. The skills needed for discovery, however, are very different than those required to realize a commercial drug product. Years and dollars are spent too often in futility — the funnel of successfully marketed drug products is small compared to the myriad of candidates. It’s clear that a different brilliant science (and process) is required to deliver high probabilities of success in achieving a viable drug product ready for commercialization. The US Food and Drug Administration (FDA) expects cogent rationale within submissions for what, how and why chemistries are used and that the manufacturer demonstrates clear process robustness to produce a product that meets quality standards of efficacy, stability and safety.
In this free webinar, the featured speaker will demonstrate how the Quality by Design cascade ensures this expectation is not only met but is clearly articulated in specific terms. This presentation will include an in-depth overview of all four stages of the Quality by Design process.
Speaker
Ron Ortiz, Sr. Director of Operations Excellence, Nitto Avecia Pharma Services, Inc.
Ron Ortiz is the Senior Director for Operations Excellence and Head of Proposals, Projects and Customer Advocacy. He oversees the customers’ experience from proposal initiation to program execution. Ron also collaborates with other site leads on all aspects of the business from strategy setting to manufacturing and laboratory performance. Previously, he was Director for Manufacturing Science and Technology for Pacira Pharmaceuticals, Inc. in San Diego, California where he led the identification, planning and execution of improvements to production throughput and product quality. He has 25+ years of experience in manufacturing and supply chain, spanning several industries including semiconductor (Air Products & Chemicals), aerospace and defense (Raytheon), medical device (Johnson & Johnson) and pharmaceuticals.
Message PresenterWho Should Attend?
This webinar will appeal to senior-level managers and executives working in the following areas:
- Drug companies looking for their first Contract Development and Manufacturing Organization (CDMO) partner
- Early-phase companies looking to build their submissions
- Second or third product pipeline companies that felt the pain of time and cost on their first product
What You Will Learn
Participants will learn about:
- An overview of Quality by Design
- The value of investing time and money early to elucidate, characterize and verify:
- Target Product Profile
- Quality Target Product Profile
- Critical Quality Attributes
- Critical Process Parameters
- How Quality by Design lowers risk and improves submission strength
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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