In this first installment of a three-part webinar, Walt Murray gives an overview of ISO 13485:2016, introduces the new high-level system and presents the risk- and opportunity-based orientations that will allow you to advance your system and business. …
In this first installment of a three-part webinar, Walt Murray gives an overview of ISO 13485:2016, introduces the new high-level system and presents the risk- and opportunity-based orientations that will allow you to advance your system and business. …
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 Laboratories share detailed insights on what to expect and how to prepar…
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 webinar series on FDA inspections, Walt Murray, a certified lead auditor in…
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 to gain access to the following CAPA Management information:Four Webin…
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Gauge the specifics and magnitude of quality events employing the “5W” technique for optimizing quality management systems by asking these questions:
Quality guru Ken Peterson hosts this first installment of a three-part series. |
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Gauge the specifics and magnitude of quality events employing the “5W” technique for optimizing quality management systems by asking these questions:
Quality guru Ken Peterson hosts this first installment of a three-part series. |
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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 resolution meeting, so that the parties resolve issues before the standard is published. So in effect, the standard has been approved at this point, and only very technical issues would be addressed before its publication.
Accordingly, many companies have a conundrum if they want to maintain both ISO 9001 and ISO 13485 certification: How to comply with the varied requirements within only one quality system. The array of opportunity may not be as broad in terms of rationalizing how to do business as an outlier. In other words this standard is now at a new level of application based on these three points:
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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 study brings about its own level of documentation, complexity, collaboration, information exchange, milestones and activities which must be managed as evidence of GCP compliance and the scientific credibility of the clinical study. The ability to manage all of the interactions required by all participants and contributors, such as sponsors, CROs, vendors and study sites in a secure and organized manner ensures the completeness, compliance and “audit readiness” of a clinical trial and Trial Master File (TMF).
The MasterControl eTMF Manager™ is an electronic trial master file management solution designed to enable real-time visibility into the status of all activities pertaining to a clinical study. Based on the TMF Reference Model, the eTMF Manager provides management of all documents, tasks, milestones and activities (such as monitoring visits and audits) required during a clinical trial, while allowing both sponsors and CROs to track the progress of pending, ongoing, and completed actions. |
The BlogNotions Life Sciences Newsletter delivers a diverse series of perspectives provided by thought leaders in the life sciences industries. Presented by NetLine, this forum delivers compelling updates on the latest technological advances, discussio…
