The Webinar Training Pass

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.

Select webinars have been pre-approved by RAPS as eligible for up to 1.5 credits toward a participant’s RAC recertification. Please enter keyword RAPS below for a list of eligible on-demand webinars.

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Webinar Training Pass

Description: Using real-life examples, loss control expert Sara Dyson shows how others have handled liability issues related to off-label promotion, explaining what they did right and where they went wrong. Topics include:

  • What off-label use and promotion is and how to avoid it;
  • Products liability causes of action related to off-label promotion; and
  • Two major defenses against liability that are undercut by off-label promotion

Presentation: Download the presentation

Speaker: Sara Dyson, Assistant Vice President of Loss Control, Medmarc Insurance Group

Description: ANDA expert Andy Papas teaches how to achieve first-pass approvals for new generic drug products. Topics include:

  • What impact GDUFA is having on today's ANDA applications and how sponsors should be responding;
  • How to assure you've adequately addressed bioequivalence requirements ahead of time; and
  • Key considerations to address FDA-identified completeness, quality, and bioequivalence issues.

Presentation: Download the presentation

Speaker: Andy Papas, Vice President of Regulatory Affairs at NSF Health Sciences Pharma Biotech

Description: Noted regulatory affairs specialist Cheryl Wagoner explains how to craft 510(k) applications for software-containing devices that will win approval the first time. Topics include:

  • What makes your software a medical device?
  • How do you define and support Level of Concern determination?
  • 11 software-related documentation sections you should include.

Presentation: Download the presentation

Handout: Download the handout

Speaker: Cheryl Wagoner, Principal Consultant/Owner of Wagoner Consulting LLC

Description: Noted serialization authority Bill Fletcher explains how to build a track & trace system that will comply with current and future global regulations without requiring new software or hardware. He discusses:

  • Best practices for aligning US requirements with those from other countries, including Brazil, China, the EU and more;
  • How to build a steering committee and expanded team that has the proper subject matter experts; and
  • Best practices for integrating serialization within existing SOPs.

Presentation: Download the presentation

Speaker: William Fletcher, Managing Partner, Pharma Logic Solutions, LLC

Description: Experts Julie Larsen and Arnold Solomon cover current FDA enforcement and inspection trends, including how to:

  • Identify and link current trends to an inspectional readiness program;
  • Understand the risk-based approach to preparing SMEs and using simulated inspection scenarios; and
  • Answer 10 key questions to determine a manufacturer's state of readiness for inspection.

Presentation: Download the presentation

Speakers: Julie Larsen, Director of Inspection Readiness, BioTeknica; Arnold Solomon, President, FDA Strategic Compliances, LLC

Description: Clinical trials regulatory expert Scott Cunningham discusses compliance issues involved in the federal trial data repository, as well as data disclosure initiatives in the US and EU. He covers:

  • The FDA's definition of an "applicable trial;"
  • The history and development of Clinicaltrials.gov; and
  • Industry concerns.

Presentation: Download the presentation

Speaker: Scott Cunningham, Partner, Covington and Burling LLP

Description: Recall specialists Neil O'Flaherty and Casper (Cap) Uldriks outline the FDA's draft guidance on distinguishing between a device recall and a product enhancement and explain what the agency expects of devicemakers.

Presentation: Download the presentation

Speakers: Neil O'Flaherty, Principal Attorney, and Casper Uldriks, Counsel of Attorneys, OFLW Law

 

Description: Post-market risk management expert Joe Falvo demonstrates how to integrate best practices throughout the recall process, including:

  • Effective SOPs for recalls;
  • Techniques to identify correction, removal and withdrawal;
  • The steps of notification and acknowledgement audits; and
  • Strategies for an effective recall execution.

Presentation: Download the presentation

Speaker: Joe Falvo, Senior Manager: Post Market Risk Management, Ortho Clinical Diagnostics

 

Description: Liability experts Marialuisa Gallozzi and Suzan Charlton outline how companies can recapture the financial cost of a recall through liability insurance. They answer such questions as:

  • How and why do you measure and document the financial and other costs of a recall? 
  • Can you purchase insurance coverage for recall-related losses and liabilities and recover from insurance when a recall happens?
  • What lessons do prior recalls teach about financial risk management and cost-capture planning before a recall happens? 

Presentation: Download the presentation

Speakers: Marialuisa Gallozzi, Partner, Covington & Burling, and Suzan Charlton, Special Counsel, Covington & Burling

 

Description: Pfizer regulatory counsel Todd Halpern walks step-by-step through the process for developing and implementing stress-tested Internal Recall Committees. He covers:

  • How to design an efficient process and cross-functional team;
  • Best practices for communicating with regulators, healthcare professionals and other key stakeholders; and
  • The difference between a market withdrawal and a recall.

Presentation: Download the presentation

Speaker: Todd Halpern, Assistant General Counsel, Regulatory Law, Pfizer