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Process Validation Principles and Protocols for Medical Devices The benefit of a consistent process is that the yield meets expected criteria. Firms that are able to implement such processes minimize their process rejections and therefore maximize profit. Live Thursday, May 31, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes $245.00
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Computer System Validation: Step-by-Step This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software validation minimized documentation and ensures efficient implementation of new and upgraded computer systems. This experience will prepare you to perform a validation project. Live Thursday, May 31, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:75 Minutes $245.00
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Best Practices for Medical Device Reporting (MDR), Recall, Reports of Corrections and Removals In the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident. Live Thursday, May 31, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes $245.00
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Auditing Analytical Laboratories for FDA Compliance Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. Live Tuesday, June 5, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes $245.00
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Excel Spreadsheet Validation to Eliminate 483s 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. Live Tuesday, June 5, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:75 Minutes $245.00
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Leadership in Manufacturing Contamination Control The Microbiology Lab must take leadership in contamination control support for production because it is the hub of the necessary technical expertise. Live Tuesday, June 5, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes $245.00
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Lean-Agile Project Management in a cGMP Environment This webinar is not a project management certification course. It is designed to provide the tools necessary to assist those designing a result or deliverable to achieve that end. It will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale. Live Wednesday, June 6, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes $245.00
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Implementing Management Responsibility for Medical Devices The FDA's Quality System Regulation (QSR) prescribes the Quality Management System for a medical device manufacturer who markets in the US. Live Wednesday, June 6, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:75 Minutes $245.00
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Effective Corrective and Preventive Actions (CAPA): 10 Steps This CAPA training program helps you to understand, in 10 easy steps, the entire CAPA process. It includes elements of Quality Tools, Team Effectiveness, Awards & Recognitions, and Verification & Validation of actions taken. Attend this webinar to grasp the A to Z of CAPA and learn how to implement & manage it for success. Live Thursday, June 7, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 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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| Risk-Based Monitoring of Clinical Trials | |
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Duration:90 Minutes $50.00
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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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| 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 $245.00
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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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| 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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| 21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits | |
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This webinar details both regulations and provides details for implementing computerized systems. Recorded View Anytime Duration:90 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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This Webinar is designed for people involved in document preparation and maintenance, and those who have involvement with documentation. Recorded View Anytime Duration:60 Minutes $295.00
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