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: Leading clinical trial disclosure expert Scott Cunningham covers recent initiatives and possible changes proposed in both the U.S. and EU. Topics include:
  • Congressional action on two bills introduced in 2013 – the Trial and Experimental Studies (TEST) Act and the Clinical Trial Cancer Mission 2020 Act;
  • The proposed shift in EMA’s disclosure policy; and
  • The FDA’s June 2013 request for comments on its proposal to release de-identified data.

Presentation: Download the presentation

Speaker: Scott Cunningham, Esq, Partner, Covington & Burling LLP

Description: Noted QSR expert Dan O’Leary provides a soup-to-nuts examination of controlling nonconforming product problems to avoid FDA sanctions and recalls. From an in-depth look at QSR requirements to inspection preparation, O’Leary covers:
  • The five steps involved in handling nonconformance problems;
  • Training personnel to identify and deal with problems;
  • Types of disposition of nonconformance problems; and
  • Conducting failure investigations.

Presentation: Download the presentation

Handout: Nonconforming Product Checklist

Speaker: Dan O’Leary, President, Ombu Enterprises

 
ADE? Or ADR?
77 minutes
Description: Top drug development consultant Hoss Dowlat illustrates some of the many pitfalls in new EU pharmacovigilance regulations regarding medication errors using real-world case studies. Dowlat covers:
  • Differences between an Adverse Drug Event and an Adverse Drug Reaction and what should be reported in the EU;
  • Product design to minimize medication errors;
  • Proactive risk assessment guidance from the FDA and the EMA; and
  • Setting thresholds for inclusion of ADRs.

Presentation: Download the presentation

Speaker: Dr. Hoss Dowlat, Ph.D., VP-Regulatory Affairs, PharmBio Consulting

 
Description: Hoffman LaRoche/Genentech veteran Ken Schiff demonstrates how to use quality risk management principles, electronic data capture and other IT systems to monitor clinical trial sites remotely. Topics include:
  • Automatic analysis of existing data that allows continuous risk management;
  • Calculating risk priority; and
  • Key steps for QRM implementation.

Presentation: Download the presentation

Speaker: Ken Schiff, President and Owner, Quality Risk Management Associates, LLC

 
Description: Consultant Kim Egan explains how the FDA regulates cosmetics and what the agency considers a drug. Topics include:
  • GMP requirements;
  • Banned and restricted substances; and
  • Cosmetics labeling rules.

Presentation: Download the presentation

Speaker: Kim Egan, Principal, Saltbox Consulting

Description: Attorney Kari Sutherland details important features of an OTC product that FDA guidance recommends should prompt a self-selection study. Sutherland also covers:
  • Self-selection study design, objectives and conduct;
  • How to conduct label comprehension studies; and
  • When to conduct actual use studies.

Presentation: Download the presentation

Speaker: Kari Sutherland, Attorney, Butler, Snow, O’Mara, Stevens & Cannada, PLLC

Description: Industry expert Barbara Immel examines issues with parenteral products in FDA inspections and how to avoid warning letters. Topics include:
  • Recent compliance cases;
  • FDA inspection ratings; and
  • How the FDA conducts drug and biologics inspections.

Presentation: Download the presentation

Speaker: Barbara Immel, President, Immel Resources LLC

Description: Pharmatek’s Bryan Knox explains his company’s strategy for making sure the chemistry and manufacturing section of a drug application will pass FDA muster. Knox outlines a “scorecard” model that assesses:
  • API stability and potency;
  • Formulation and dosage strength;
  • Level of CMC expertise required.

Presentation: Download the presentation

Speaker: Bryan Knox, Senior Director of Pharmaceutics, Pharmatek

Description: A team of regulatory experts outlines the requirements of the Physician Payment Sunshine Act and the reporting timeline. Topics include:
  • Common issues and gaps in reporting;
  • Managing physician relationships; and
  • Designing an inquiry and dispute resolution system.

Presentation: Download the presentation

Speakers: Tim Robinson, Esq., Executive Vice President and General Counsel, MMIS, Inc. and Seth Lundy, Esq., Partner, King & Spalding

Description: Medical device compliance expert Dan O’Leary shares his device history record (DHR) management plan that follows the requirements of the Quality System Regulations. O’Leary covers:
  • Standard flow of information from design input to servicing;
  • Types of device-specific records;
  • Exceptions for Class I devices; and
  • Unique device identification.

Presentation: Download the presentation

Speaker: Dan O’Leary, President, Ombu Enterprises LLC