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Home » Webinars

Now get all the training you need – all in one place, and all for one low price!

The FDAnews Webinar Training Pass program gives you year-round unrestricted access to any of the hundreds of webinars listed below. These training programs feature top consultants, expert speakers and FDA officials.

PLUS, subscribers get automatic access to all our new training programs for the next 12 months – that’s more than 50 new programs a year!

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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BUY NOW Single-User 1-Year Unlimited Access $1,362

Also available: Take advantage of our multi-user and site licenses of the Webinar Training Pass, so you’ll have the most-informed workforce! Contact James DeFalco, Sales Director at jdefalco@wcgclinical.com or +1 703.538.7638 to receive a custom quote.

Search by keyword, speaker name or just by category (drug, device or clinical) and you'll find all you need.

If you have any questions or are having any problems please give us a call on 703.538.7600 or email customer service.

Webinar Training Pass

Creating, Staffing and Managing an Inspection War Room
54 minutes
Description: Legal authority Darshan Kulkarni outlines a strategy for springing into fast action with an inspection “war room” that can address any issue. Kulkarni covers:
  • Roles and responsibilities for personnel involved in inspections;
  • How to greet inspectors and assemble the war room team; and
  • When to call on outside experts for help.

Presentation: Download the presentation

Speaker: Dr. Darshan Kulkarni, Principal Attorney, Kulkarni Law Firm

FDA-adopted Columbia-Suicide Severity Rating Scale
93 minutes
Description: A well-rounded team of experts demonstrates why flawed adverse event reporting and labeling have contributed to a suicide epidemic worldwide, putting patients and pharmaceutical companies at increased risk. After offering an overview of the current landscape and weaknesses in key programs, the team provides potential solutions, including:
  • 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.

Going "E" With Informed Consent for Clinical Trials
88 minutes
Description: Informed consent consultants Susan Brink and Sherry Bracy elucidate the benefits of electronic informed consent programs and offer an insider’s vendor evaluation process, including the answers firms should look for. Questions to ask include:
  • 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.

Medical Device Software Recalls on the Rise
76 minutes
Description: Expert David Vogel outlines FDA recall enforcement trends, and the most common shortcomings in device company recall programs. He also spotlights some less obvious device company recall program weaknesses, including:
  • 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

Off-the-Shelf Versus Custom-Built Quality Systems
40 minutes
Description: Industry expert Brian Dense assesses the strengths and weaknesses of off-the-shelf quality systems against custom solutions, providing real-world case studies that highlight the best and worst of each approach. He also focuses on avoiding several common errors when choosing the best approach, including:
  • 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

Your Clinical SOPs Are Too Long!
84 minutes
Description: SOP analysts Steven Steinbrueck and Elizabeth Bodi share ways to shorten and focus SOPs, demonstrating how to spot and prevent common mistakes, including:
  • 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

Managing EMA Drug Process Validation
80 minutes
Description: Industry analyst Thomas Peither covers important ground on the many changes to EMA drug process validation. Peither discusses:
  • 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.

MDUFA 2012
78 minutes
Description: Noted expert and former FDA official Steven Niedelman is joined by legal analyst Pamela Forrest  to provide detailed insight on the 2012 MDUFA reauthorization, device user fees, FDA performance goals, and other key provisions affecting medical devices, including:
  • 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

Insider Insight on PDUFA V
89 minutes
Description: An expert legal team maps the complex PDUFA V requirements. Topics covered include;
  • 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

Complying with FDA's Unique Device Identification Rule
77 minutes

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

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