FDA has consistently maintained its resolve to collect and analyze Quality Metrics in order to encourage the implementation of modern, risk-based pharmaceutical quality assessment systems and to include these quality metrics as a factor in their own risk-based surveillance inspection planning model. Recent draft guidance confirms their commitment to collect data voluntarily from pharma manufacturers in 2018.
For pharma manufacturers, these ‘persistent quality defects’ represent real risks to the success of their business in terms of high remediation costs and potential reputational damage.
CDER Director Dr. Janet Woodcock, has emphasized that a robust quality system is ‘only as good as the culture that supports it.
Frances Zipp and Dr. Nuala Calnan will be conducting this workshop that will not only help you understand the rationale behind the FDA’s program and prepare for the practical challenges during implementation, but also promote the opportunities to embrace quality improvement as part of business strategy.