Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans What feedback have you received from people who volunteered to participate in a clinical trial? 1.61K viewsFDA 0 Votes 1 Ans What would you say to a potential volunteer that is afraid they won’t receive the same level of care in a clinical trial as what they receive under their doctor’s care? 1.43K viewsFDA 0 Votes 1 Ans What are the most frustrating things about working in the clinical trials recruitment and retention area? 1.59K viewsFDA 0 Votes 1 Ans What do you think can be done to improve interactions between principal investigators and study teams and potential clinical trial participants? 1.29K viewsFDA 0 Votes 1 Ans What steps is ICAN taking to move the clinical trials process forward? 1.48K viewsFDA 0 Votes 1 Ans Does the CMO have a strong quality management system? 1.51K viewsFDA 0 Votes 1 Ans Does the CMO have supply chain expertise 1.59K viewsFDA 0 Votes 1 Ans Does the CMO have sufficient capacity in production and engineering? 1.60K viewsFDA 0 Votes 1 Ans How will the CMO handle your production plan? 1.46K viewsFDA 0 Votes 1 Ans Can the CMO provide staffing charts? 1.57K viewsFDA 0 Votes 1 Ans Does the CMO foster continuous improvement? 1.55K viewsFDA 0 Votes 1 Ans Is the CMO’s work culture compatible with yours? 1.36K viewsFDA 0 Votes 1 Ans Is there potential for automated processes? 1.31K viewsFDA 0 Votes 1 Ans Is the CMO financially stable? 1.42K viewsFDA 0 Votes 1 Ans Are the CMO’s facilities a good fit for your product? 1.49K viewsFDA 0 Votes 1 Ans Who is the contracting entity? 1.69K viewsFDA 0 Votes 1 Ans The transition period doesn’t end until May 2020. Why start now? 1.61K viewsFDA 0 Votes 1 Ans How do we get management on board with starting this effort now? 1.27K viewsFDA 0 Votes 1 Ans How should a company communicate to its Notified Body about timing for transitioning and implementing to ISO 13485:2016 and the new regulation? Is it appropriate to communicate using a change notification? Is there a standard process? 1.67K viewsFDA 0 Votes 1 Ans Will all Notified Bodies be re-designated? Is there a risk they won’t be? 1.62K viewsFDA « Previous 1 2 … 254 255 256 257 258 … 283 284 Next » Question and answer is powered by anspress.net
