The FDAnews Webinar Training Pass program offers year-round, unrestricted access to any of the hundreds of webinars listed below. These training programs feature thought leadership and best practices from top consultants, expert speakers and current and former FDA officials. New webinars are offered every month, along with access to the Webinar Training Pass archive.
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If you are already a Training Pass member, login below and then scroll down to view the list in date order or narrow your search by keyword or category. Viewing the webinar is easy… simply identify the webinar you want to watch, click on the title and the video will begin. If you would like to view or download the presentation materials separately from the video, click the "Download Presentation" link.
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Webinar Training Pass
- Intervention trials using prospective and systematic measurement of suicidality that more clearly delineate the relationship between suicidal adverse events and medication treatment;
- Consistent and systematic assessment that provide more meaningful data within a study, as well as across studies, improving pooled analyses;
- Understanding that decreasing false positives and debunking false notions of risk are as important as knowing about risks that exist; and
- Including suicidal subjects in trials to increase generalizability and avoid unnecessary exclusions.
Presentation #1: Download the presentation from Dr. Kelly Posner
Presentation #2: Download the presentation from Dr. John Greist
Speakers: Dr. Kelly Posner, Founder, Center for Suicide Risk Assessment at Columbia University/New York State Psychiatric Institute; Dr. John Greist, CEO, Healthcare Technology Systems and Mike Federico, Vice President, ePRO solutions, ERT Inc.
- How is system access controlled?
- Is there a robust back-up process?
- What is the process for sites if the system is down or the Internet is not available at the time you are obtaining consent from a patient?
Presentation: Download the presentation
Speakers: Dr. Susan Brink, President and CEO, Consent Solutions Inc. and Sherri Bracy, Founder and Director, Bracy Consulting LLC.
- Why large software modules more likely to fail;
- How to assess the amount, quality of testing;
- How to assess the skill and experience level of a designer – when to put the best designers on the most critical software; and
- How to assess the skill and experience level of testers.
Presentation: Download the presentation
Speaker: Dr. David Vogel, Founder, Intertech Engineering Associates
- Misunderstanding the purpose of a quality system;
- Misunderstanding regulatory requirements of the market; and
- Failing to understand that quality is a department, not an integrated practice.
Presentation: Download the presentation
Speaker: Brian Dense, President, CiNQ Systems
- Dictating how to accomplish a task;
- Mandating dates; and
- Including things that are not regulatory requirements/expectations, senior management mandates or accepted best practices.
Presentation: Download the presentation
Speakers: Steven Steinbrueck, President, Stonebridge GCP Consulting and Elizabeth Bodi, Clinical Research Senior Consultant, Halloran Consulting Group
- Why validation should be carried out in accordance with GMP;
- The need for a minimum of 3 validation batches; and
- Basing the number of batches on the variability of the process, the complexity of the process/product, and the experience of the manufacturer
Presentation: Download the presentation
Handout #1: Synopsis: FDA Process Validation Guidance
Handout #2: Guidance for Industry, Process Validation: General Principles and Practices
Handout #3: Note for Guidance on Process Validation
Handout #4: European Medicines Agency: Draft Guideline on Process Validation
Handout #5: Comparison Between EMA and FDA On Traditional Process Validation Approaches
Speaker: Thomas Peither, President, Maas & Peither America Inc.
- Conflict of interest scenarios;
- Patient participation in product discussions; and
- Nanotechnology issues.
Presentation: Download the presentation
Speakers: Steven Niedelman, Lead Quality Systems and Compliance Consultant to the FDA & Life Sciences practice team, King & Spalding and Pamela Furman Forrest, Partner, King & Spalding
- The path to market provisions;
- Distribution and supply provisions;
- User fees and performance goals.
Presentation: Download the presentation
Speakers: Peter Barton Hutt, Senior Counsel, Covington & Burling; Erika Lietzan, Partner, Covington & Burling; Scott Cunningham, Partner, Covington & Burling and Stefanie Doebler, Special Counsel, Covington & Burling
Description: On July 3, 2012, the FDA released a proposed rule on the unique device identification (UDI) system, ending a year-long delay in finalizing the much-anticipated safety mechanism. The 165-page comprehensive rule touches all aspects of the medical device industry. The FDA maintains that the UDI system helps reduce the rate of death caused by faulty devices, which the agency estimates at 17,700 over the past five years. Jeffery Shuren, director of CDRH, called the UDI rule "a major game-changer." The FDA receives numerous device-related adverse event reports, but often can't tell what device the patient is referencing. UDI makes aggregating reports easier, but at what time and cost to industry? Across the board — from supplier, provider, distributor, to consumer — who is ready? Listeners will learn what's hidden in the rule's 165 pages and where to start the journey to implementation. Siobhan O'Bara and John Roberts of GS1 will provide clarification on creating a mandatory system of unique device identifiers.
Presentation: Download the presentation
Speakers: Siobhan O'Bara, Healthcare Vice President, GS1 US and John Roberts, Director of Healthcare, GS1 US
- Develop a single, integrated regulatory/market access strategy and point of contact;
- Conduct an early landscape assessment to develop a milestone-driven strategic plan; and
- Create a new gap analysis technique to evaluate assets, determine what to leverage and what to build; and
- Update a reimbursement strategy to anticipate new market dynamics.
Presentation: Download the presentation
Speaker: Ed Dougherty, Senior Healthcare Advisor, Arent Fox