Companies that embrace Quality by Design (QbD) and a pharmaceutical quality systems approach are in a better position for successful biopharmaceutical operations, which translate into increased profits through reduced risks to customers and the business, as well as significantly reduced risks of costly deviation investigations or rejects and ensuing enforcement actions. It’s simple - designing quality into your product improves manufacturing outcomes.
As stated by FDA, “Quality cannot be tested into products; it should be built in or should be by design.” Learn how to establish the product and process design as part of a drug product life cycle to ensure that your organization’s medicinal products meet user needs, intended uses, and specified requirements. FDA, in the recent speeches by its leaders and in articles, has stressed its continually increasing focus on the QbD and Design Space approaches. This has been extended to include joint activities with the European Medicines Agency (EMA), as announced in March 2011. This approach is part of the ICH Q8, Q9, and Q10 guidelines.
For comprehensive training on the current regulatory expectations and an action plan for compliance and implementation, follow this course with Process Validation for Biopharmaceuticals (course code PVP).