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Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs) This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. Live Tuesday, February 7, 2012 10:00 AM PST | 01:00 PM EST, Duration:90 Minutes $245.00
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Safety Critical Software - Software Risk Management Using IEC62304 as the internationally recognized software lifecycle standard the risk dependent activities and documentation requirements will be explained. Live Tuesday, February 7, 2012 10:00 AM PST | 01:00 PM EST, Duration:60 Minutes $245.00
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Product Risk Management Under ISO 14971 and FDA-ICH Q9 Expectations for meaningful hazard analysis, hazardous conditions, and documentation have always existed by regulatory agencies. Live Wednesday, February 8, 2012 10:00 AM PST | 01:00 PM EST , Duration:90 Minutes $245.00
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Supply Chain Risk Management For the last decade, there has been an extensive and organized effort by organizations to assess their risks, especially in financial services. Non Financial firms are now increasing their risk management especially in the light of such complex, global, and out sourced supply chains. The new ISO 31000 and ISO 31010 frameworks provide guidelines in this process that make good sense and build on years of work by risk professionals. Live Thursday, February 9, 2012 10:00 AM PST | 01:00 PM EST, Duration:90 Minutes $245.00
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Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained 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). Live Tuesday, February 14, 2012 10:00 AM PST | 01:00 PM EST, Duration:60 Minutes $245.00
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| DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions | |
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This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR. Recorded View Anytime Duration:90 Minutes $295.00
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| Excel Spreadsheet Validation to Eliminate 483s | |
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This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. Recorded View Anytime Duration:75 Minutes $295.00
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| Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained | |
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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). Recorded View Anytime Duration:60 Minutes $295.00
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| Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained | |
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Duration:90 Minutes $50.00
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| Understanding the New USP Chapter 1224 for Transfer of Analytical Methods | |
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When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. Recorded View Anytime Duration:75 Minutes $295.00
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