How Quality by Design Changes Your Drug Product from Concept to Commercial, Upcoming Webinar Hosted by Xtalks
TORONTO (PRWEB) July 16, 2019 -- 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.
Join Ron Ortiz, Sr. Director of Operations Excellence, Nitto Avecia Pharma Services, Inc. for an informative live session on Tuesday, July 30, 2019 at 2pm EDT. Discussion points include:
- 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
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
For more information or to register for this event, visit How Quality by Design Changes Your Drug Product from Concept to Commercial.
Candice Tang, Xtalks, http://www.xtalks.com, 1 (416) 977-6555, [email protected]
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