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Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U.S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories. Live Thursday, May 17, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes $245.00
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Water System Biofilm Control and Microbial Monitoring Myths It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided? Live Tuesday, May 22, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes $245.00
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Update on Unique Device Identifier for Device Manufacturers Recent reports identified several potential benefits to widespread use of UDI, such as reducing medical errors, facilitating recalls, improving medical device reporting, and identifying incompatibility with devices or potential allergic reactions. Live Tuesday, May 22, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes $245.00
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Hazard Analysis vs. FMECA – Differences and Commonalities 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 design. Live Tuesday, May 22, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes $245.00
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DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR. It will consider the MDD's TF/DD requirements, and evaluate the documents' differing purposes / goals. Live Wednesday, May 23, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes $245.00
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Lyophilization Process Development and Cycle Design with a Case Study This webinar will cover the process and benefits of using an empirical approach to design an optimized lyophilization cycle. In the past, a "trial and error" approach was routinely used as the means of cycle design, often resulting in products that were substandard or cycles that were prohibitively long and expensive. Live Thursday, May 24, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes $245.00
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Validation of Analytical Methods for FDA Compliance: Step-by-Step Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented. Live Thursday, May 24, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:75 Minutes $245.00
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Using Statistics to Determine Sample Size This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a certain level of process capability will be covered. Live Tuesday, May 29, 2012 12:00 PM PDT | 03:00 PM EDT, Duration:60 Minutes $245.00
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Risk-Based Monitoring of Clinical Trials: Say Goodbye to 100% Source Document Verify The presentation reviews the long-awaited 'Guidance for Industry: Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring' which was released in August of 2011 to 'enhance human subject protection and the quality of clinical trial data. Live Tuesday, May 29, 2012 10:00 AM PDT | 01:00 PM EDT, 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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| Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 | |
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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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