FDA Just Called! Now What?

What does it mean to be in a constant state of readiness for an audit? In this webinar, quality management and regulatory affairs professionals from MasterControl and Underwriters...

FDA Just Left! Now What?

Your inspection may be complete, but your post-inspection action items should actually begin before the inspector walks out the door. In this second installment of a three-part...

CAPA Toolkit

MasterControl has invested over 240 expert hours into the creation of this CAPA Toolkit that provides all the materials needed to build an efficient, compliant CAPA program.Download...

Clinical Study eTMF Manager

The management of a Trial Master File (TMF) for a clinical study goes beyond simply managing the creation, review and approval of content that is included in a TMF. Each clinical...

ISO 13485 – Change? Do I Have to??

Once a standard has reached the Final Draft International Standard (FDIS) stage, comments and objections have been addressed. Each technical reason is addressed in a comments...
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