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: 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

Description: Supplier management pro John Avellanet explains how to audit suppliers that have no physical site to visit. Avellanet covers:
  • Definitions of “virtual manufacturer,” “virtual company,” and “virtual enterprise;”
  • How to tell if a supplier is a virtual operation;
  • What records to keep to prove to FDA inspectors that you have audited suppliers; and
  • Items to request from a supplier being audited.

Presentation: Download the presentation

Speaker: John Avellanet, Managing Director, Cerulean Associates LLC

 
Description: Quality risk management expert Ken Schiff examines quality risk management and how it applies to clinical development. Topics include:
  • Using quality risk management to assess data more frequently and effectively;
  • Protocol quality by design; and
  • Risk assessment questionnaires and reporting models.

Presentation: Download the presentation

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

Description: Industry expert Dan O’Leary analyzes FDA warning letters to demonstrate how understanding the agency’s enforcement emphasis can help inform a robust acceptance program. O’Leary provides insight on:
  • Definition of key terms;
  • How to understand and leverage sampling plans; and
  • How to adequately respond to an FDA warning letter.

Presentation: Download the presentation

Handout: Download Checklist for acceptance activities

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

Description: Industry expert Dean Calhoun covers the landscape of regulator and patient issues, with special focus on the best tools to assess and mitigate risk, including:
  • Failure Mode and Effects Analysis;
  • Fault Tree Analysis; and
  • HAZOP

Presentation: Download the presentation

Speaker: Dean Calhoun, President, Affygility Solutions