Search Webinars
Featured Speakers
|
Speaker Opportunity
Suggest a Topic
Subscribe NewsletterCustomer Testimonials
|
|
- Upcoming Webinars
- Most Attended Webinars
-
|
European Union Filings and Registrations This session covers the various licensing methods (for Drugs, Biologics & Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States, as well as fully across all Member States of the European Union. This course specifically outlines and discusses the structure of the regulatory agencies at the EU-level and across specific Member States. Course content will explain which procedures are available for which products and then will follow the license processing steps for each pathway. Live Tuesday, May 21, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes $245.00
|
|
|
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, May 21, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes $245.00
|
|
|
Device Changes, FDA Changes, and the 510(k) The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". Live Wednesday, May 22, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes $245.00
|
|
|
Key Concepts in Successful Water System Sanitization Though hardly a water system is designed and installed without some capability of sanitization, the system design features, materials of construction, sanitization chemical choices and how they are used, as well as the frequency of the sanitization process have everything to do with its success. Live Thursday, May 23, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes $225.00
|
|
|
FDA 510(k): Preparation, Submission, and Clearance This webinar is intended to demonstrate how to prepare a 510(k), submit, and get it cleared in a manner with increased quality so that the review process can be expedited. The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices. Live Thursday, May 23, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes $225.00
|
|
|
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
|
|
|
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
|
|
|
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
|
|
|
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
|
|
| Test | |
|
Duration:60 Minutes $50.00
|
|
| 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. Recorded View Anytime Duration:90 Minutes $295.00
|
|
| 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. Recorded View Anytime Duration:75 Minutes $295.00
|
|
| 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). Recorded View Anytime Duration:60 Minutes $295.00
|
|
| 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. Recorded View Anytime Duration:75 Minutes $245.00
|
|
| Understanding the New USP Chapter 1224 for Transfer of Analytical Methods | |
|
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
|
|
| 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). Recorded View Anytime Duration:60 Minutes $295.00
|
|
| 21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits | |
|
This webinar details both regulations and provides details for implementing computerized systems. Recorded View Anytime Duration:90 Minutes $295.00
|
|
| Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained | |
|
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
|
|
