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: Regulatory expert Rita King explains the requirements of IEC 62304 for all electromedical devices where basic safety or essential performance is dependent on software or firmware. She discusses:

  • How to identify the two biggest pitfalls: documentation and software pedigree;
  • How to understand and address three key noncompliance factors: software partitioning, document development and version control/updates; and
  • How to write a Test Report Form that will stand up to FDA scrutiny.

Presentation: Download the presentation

Speaker: Rita King, CEO, MethodSense

This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.

Description: Device attorney Jodi Scott advises devicemakers on handling FDA inspections, covering such topics as:

  • How to advocate for your company in the post-inspection environment;
  • 29 tips for what to do once an investigator shows up for an inspection; and
  • Responding properly to a Form 483.

Presentation: Download the presentation

Speaker: Jodi Scott, Partner, Hogan Lovells

This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.

Description: Life sciences attorney Stacie Ropka provides an analysis of FDA oversight of HCT/Ps, with a focus on what the draft guidelines mean for the future of regulatory scrutiny. She discusses:

  • The FDA's position on when a HCT/P constitutes a drug/device and what resulting requirements need to be fulfilled;
  • How the courts have interpreted "minimal manipulation;" and
  • What processes in the draft guidances constitute some of the acceptable forms of minimal manipulation.

Presentation: Download the presentation

Speaker: Stacie Ropka, Counsel, for Axinn, Veltrop & Harkrider, LLP

This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.

Description: Attorney Frederick Stearns explains the FDA's new "general wellness" classification for medical devices and apps. He discusses:

  • How to make sure your health claims are "wellness" not "treatment" claims that will run afoul of the FDA's rules;
  • How to be sure your device satisfies FDA criteria for low-risk treatment; and
  • How to apply the agency's five-step test to determine whether your device falls under the FDA's general wellness exemptions.

Presentation: Download the presentation

Speaker: Frederick Stearns, Partner, Keller and Heckman

This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.

Description: GMP trainer Joanne Cochran offers guidance on training subject matter experts to face subject-specific teams of FDA investigators under the agency's new inspection plan. She covers:

  • How to be assured your SMEs are aligned to the topics they are going to be asked about;
  • Improving SME effectiveness by conducting thorough simulated inspection scenarios; and
  • Examples of questions commonly asked by investigators and answers that are typically found satisfactory.

Presentation: Download the presentation

Speaker: Joanne Cochran, President, JWC Training Associates

This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.

Description: Attorney Scott Cunningham helps regulatory affairs and clinical trial management teams to prepare for upcoming changes in clinical trial data reporting. Topics include:

  • Assuring that entries in ClinicalTrials.gov are consistent with internal records and addressing gaps in reporting;
  • Determining when the 21-day rule begins;
  • The ramifications of submitting trials on off-label drugs; and
  • How much data is expected for adverse events.

Presentation: Download the presentation

Speaker: Scott Cunningham, Partner, Covington and Burling, LLP

This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.

Description: Regulatory affairs expert Mukesh Kumar teaches how to structure a risk-based raw materials management program suited for the GMP environment. Topics include:

  • FDA's expectations regarding raw material vendor selection;
  • Proven and cost effective measures for assuring acceptable quality of materials;
  • Sampling and assurance documentation quality control units expect; and
  • Training requirements for frontline employees and managers.

Presentation: Download the presentation

Speaker: Mukesh Kumar, Regulatory Affairs and Quality Assurance, Amarex

This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.

Description: Supplier management expert Jeff Kasoff offers proven techniques for complying with FDA QSR and ISO 13485 supplier management requirements. He covers:

  • The latest interpretation of QSR and ISO 13485 requirements for supplier selection and assessment — and how US and EU investigators are applying it during inspections;
  • How to on-board and qualify new suppliers in a cost-efficient manner; and
  • Innovative assessment techniques for current suppliers.

Presentation: Download the presentation

Speaker: Jeff Kasoff, Director of Quality, Medivators

This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.

Description: Drug and device expert Lynn C. Tyler explains the potential impact of the FDA's final guidance, "Circumstances that Constitute Delaying, Denying, Limiting, or Refusing to Permit Drug Inspection." He provides:

  • Legal and operational strategies for responding to FDA's assertion of increased authority; and
  • Best practices for coordinating between the investigator, regional office and FDA headquarters if disagreements arise in the conduct of an inspection.

Presentation: Download the presentation

Speaker: Lynn C. Tyler, Partner, Barnes and Thornburg, Food, Drug and Device Law Practice Group

This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.

Description: Regulatory expert Michael Swit uses FDAnews' exclusive FDA Form 483 database to demonstrate how analyzing these documents can help you prepare for your next inspection. He discusses:

  • What can be learned from examining 483s;
  • How to respond to a 483; and
  • FDA expectations.

Presentation: Download the presentation

Speaker: Michael Swit, Special Counsel, Duane Morris LLP