TORONTO – OCTOBER 12, 2021 – A robust approach for combination drug product development requires an understanding of the drug product characteristics, the effects of processing and device design and how they impact product performance. Risk management connects the dots and interactions of these critical factors.
A key component of risk management is the utilization of Quality by Design (QbD) principals.
In this webinar, the speakers will:
- Take a deep dive into the critical components of a QbD approach including the evaluation of the quality target product profile (QTPP), critical quality attributes (CQA) of the drug product, critical processing parameters (CPP) and critical material attributes (CMA) of raw materials
- Draw parallels with device design controls which align with compliance requirements and product performance characteristics which align with user/device interactions (human factors)
- Discuss differences in experimentation from development studies to quality control
- Review FDA requirements that include an implicit risk analysis
Join Justin Lacombe, PhD, Chief Scientific Officer, Experic LLC and Julie D. Suman, RPh, PhD, President, Scientific Affairs, Next Breath, for the live webinar on Thursday, October 28, 2021 at 11am EDT (4pm BST/UK).
For more information, or to register for this event, visit Combination Drug Products: What Lies Beneath – Risk Analysis for Product Development