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Global Medical Device Adverse Event Reporting Systems in EU, Canada and US 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 Tuesday, May 28, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes $225.00
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Device Corrections and Removals When your firm finds a problem with one of the devices you already shipped, fix it for the customer. Do you report it to the FDA? Live Tuesday, May 28, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes $245.00
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Medicaid Vs. Medicaid EHR Incentives & Meaningful Use Certifications in US An electronic health record (EHR) allows providers to record patient information electronically instead of using paper records. The EHR Incentive Program asks providers to use the capabilities of the EHRs to improve patient care. Live Wednesday, May 29, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes $225.00
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e-Submissions & Data Standards for FDA (eCTD, CDISC, HL7) Each FDA center has different guidelines and processes to follow in order to have a successful submission for the regulatory review of the medical product. The submission process for drugs, biologics and medical devices is rigorous and has specific timelines and standards to follow. Live Thursday, May 30, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes $225.00
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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. All medical devices that are imported into the U.S. must meet Bureau of Customs and Border Protection (CBP) requirements in addition to FDA. Product that does not meet FDA regulatory requirements may be detained upon entry. Live Thursday, May 30, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes $245.00
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The Hitchhiker's guide to 483s and Warning Letters Audits by the FDA are perhaps the most intimidating of all events at a regulated facility. A fun way to present this serious topic!! 483’s and their more serious counterparts, Warning Letters, are Citations issued by the FDA as a result of issues uncovered during an Inspection. Live Thursday, May 30, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:2 Hours $199.00
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Foreign Material Control Establishing HACCP, Preventative and Corrective Maintenance, GMPs and Pest Control programs will reduce foreign material contamination incidences and ensure safe, wholesome, unadulterated products for consumers. Live Tuesday, June 4, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes $165.00
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How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? Live Tuesday, June 4, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes $199.00
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GxP Computer System Validation, The investigator's Point of View
The webinar explains what is needed to prepare for an audit or regulatory inspection. It addresses SOPs for the GxP and IT infrastructure, hardware and software qualification, computer system validation, and change control for revalidation. This event is applicable to regulated companies and software vendors. Live Tuesday, June 4, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes $245.00
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| Test | |
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Duration:60 Minutes $50.00
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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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