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...
CAPA Part 1: Improving CAPA Systems with a Closed-loop Methodology
Gauge the specifics and magnitude of quality events employing the “5W” technique for optimizing quality management systems by asking these questions:What?Where?When?Weight?Who?Quality...
CAPA Part 1: Improving CAPA Systems with a Closed-loop Methodology
Gauge the specifics and magnitude of quality events employing the “5W” technique for optimizing quality management systems by asking these questions:What?Where?When?Weight?Who?Quality...
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...
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...
BlogNotions Life Sciences Newsletter: Monthly eNewsletter Featuring Blogs from Industry Experts
The BlogNotions Life Sciences Newsletter delivers a diverse series of perspectives provided by thought leaders in the life sciences industries. Presented by NetLine, this...
BlogNotions Life Sciences Newsletter: Monthly eNewsletter Featuring Blogs from Industry Experts
The BlogNotions Life Sciences Newsletter delivers a diverse series of perspectives provided by thought leaders in the life sciences industries. Presented by NetLine, this...
How Life Sciences Companies Can Achieve HIPAA Compliance In The Cloud
Companies that can demonstrate patient outcomes will hold a distinct competitive advantage. To gain that advantage, they must know how to comply with HIPAA rule – or better...
