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Medical Device Adverse Event Reporting in EU, US and Canada Medical device firms' obligation doesn't end upon obtaining a marketing clearance, approval, or certificates. Medical device manufacturers are required to report adverse events to the authorities (e.g., Competent Authorities, Health Canada and US FDA), where applicable. Live Thursday, June 20, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes $225.00
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FDA's 21 CFR 11 Add-On Inspections - Recent Updates In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations. Live Thursday, June 20, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:2 Hours $245.00
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The 510(k) Submission: Requirements, Contents, and Options This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company's regulatory and financial health. Your goal is to get the 510(k) through the review process as quickly as possible. Live Thursday, June 20, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes $245.00
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Webinar on BRC Risk Analysis Risk Assessment is a fundamental and intuitive activity that is not new to manufacturing professionals. Bringing consciousness and tangibility to this process is the challenge often faced. A practical guide documenting the process will be the topic of this training. Live Wednesday, June 26, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes $165.00
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Setting Up and Running a Tougher Supplier Audit Program The last few years have seen the U.S. FDA come under increasing negative public scrutiny. High profile drug recalls, food chain problems and contamination, import problems, resignations. Now a new commissioner vows no more "business as usual". Live Wednesday, June 26, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes $245.00
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Do's & Don'ts during FDA Inspections The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control. The key to a successful audit is being able to communicate how your quality systems assure this state of control. Live Wednesday, June 26, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes $225.00
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Complaint Handling and Management: From Receipt to Trending 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. Live Thursday, June 27, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes $225.00
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FDA-Compliant Medical Device Design Control Understanding, interpreting, and implementing design control requirements in a holistic manner can significantly expedite the regulatory processes, bringing innovative medical products to the global market faster and saving enormous amount of your unnecessary time, efforts and investment. Live Thursday, June 27, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes $199.00
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Device Master Record & Device History Record The FDA's Quality System Regulation (QSR) requires each device manufacturer to compile the specifications and procedures for a medical device. The manufacturer must also compile records of the production history of the device. These two sets of records (DMR & DHR) are complimentary. Live Tuesday, July 9, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes $245.00
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Duration:60 Minutes $26.00
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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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| 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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