Implementing ICH Q14’s Enhanced Approach to Analytical Method Development, FDA's Proposed Framework for Human Factor Info in Device Submissions + Warning Letter Breakdown
Implementing ICH Q14’s Enhanced Approach to Analytical Method Development, FDA's Proposed Framework for Human Factor Info in Device Submissions + Warning Letter Breakdown
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Watch now (46 min) | We explore FDA's new list of alternative ways to comply with cGMP requirements for combo products, dissect a new draft guidance for device companies, and break down a Warning Letter.
Implementing ICH Q14’s Enhanced Approach to Analytical Method Development, FDA's Proposed Framework for Human Factor Info in Device Submissions + Warning Letter Breakdown
Implementing ICH Q14’s Enhanced Approach to…
Implementing ICH Q14’s Enhanced Approach to Analytical Method Development, FDA's Proposed Framework for Human Factor Info in Device Submissions + Warning Letter Breakdown
Watch now (46 min) | We explore FDA's new list of alternative ways to comply with cGMP requirements for combo products, dissect a new draft guidance for device companies, and break down a Warning Letter.