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| Articles by John Robinson |
131. FDA's New Guidance On Medical Device Development Tools (MDDT); Qualification of MDDT for Patient As
April 14, 2014
Overview:
This webinar will discuss a voluntary process for qualification of Medical Device Development Tools (MDDT) for use in device development. An MDDT is a scientifically validated tool (test) to determine clinical outcome. Qualification reflects CDRH (FDA's) expectation that within a s...
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132. U.S Veterinary Biological Development and Registration
April 14, 2014
Overview:
The Development of veterinary biologics, involves a complex series of clinical studies and analytical programs to assure the quality and effectiveness of these products. Biologicals are commonly vaccines and include conventional viral based products, bacterins, toxins, rDNA product...
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133. Complaint Handling and Management: From Receipt to Trending
April 14, 2014
Overview:
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. ...
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134. Design History File (DHF), Device Master Record (DMR), Device History Record (DHR)
April 14, 2014
Overview:
The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). Do you know wha...
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135. Hazard Analysis vs. FMECA - Differences and Commonalities
April 14, 2014
Overview:
The terms "Hazard and Risk Analysis" and "Failure Mode, Effects and Criticality Analysis (FMECA)" are often used synonymously.
However, there are significant differences in both methodologies and their strengths can be combined to ensure a safe and efficacious system desig...
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136. 2-day In-person Seminar on The A to Z's of Writing and Enforcing Effective SOPs (Standard Operating
April 02, 2014
Overview:
This session will discuss key considerations for Good Documentation Practices that would impact product quality, safety, and efficacy and/or data integrity. Key components of documentation and record management system will be introduced. Regulatory requirements will also be discuss...
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137. 2-day In-person Seminar on Validation and 21 CFR Part 11 Compliance of Computer Systems at Zurich,
April 02, 2014
The Problem:
Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect ...
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138. 2-day In-person Seminar on Medical Device Software Risk Management and Assurance Case at Los Angele
April 02, 2014
Overview:
Gaps, incorrect or incomplete implementation of software can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct imple...
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139. 2-day In-person Seminar on Statistical Sampling Plans - Methods and Applications at SFO, CA
April 02, 2014
Overview:
Many companies use acceptance sampling as a standard business practice. The most common applications use attribute sampling based on ANSI/ASQ Z1.4 andZero Acceptance Number Sampling Plans by Nicholas L. Squeglia. These common methods are not always the best approaches. This seminar...
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140. 2-day In-person seminar on Effective Complaint Handling, Medical Device Reporting and Recalls at Ba
April 02, 2014
Overview:
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. Th...
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Author: John Robinson
