Dear Colleagues,
In preparation for regulatory inspections, it is important to be aware of current expectations, trends and opportunities. We welcome your thoughts on the following:
- What unexpected regulatory inspection observations are you aware of that required a significant change in Continuous Manufacturing strategy?
- Please share quality-specific challenges identified by regulators.
- What significant differences in regional regulatory expectations have you encountered?
- What specific industry guidance documents and/or tools would you like to see established to facilitate implementation and approval of CM?