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: Supply chain analyst Hedley Rees advises on the most effective techniques for forecasting and managing clinical trial materials needs. Topics covered include:

  • Mapping the end-to-end physical flow of the supply chain;
  • Key information flows in the supply chain; and
  • Prerequisites for successful delivery of drug to site.

Presentation: Download the presentation

Speaker: Hedley Rees, Managing Consultant, Pharma Flow

 

Description: Experts George Valaitis and Jean Colombel present a case study from AB SCIEX, a leading medical and laboratory equipment manufacturer, showing how they were able to reduce business risk and avoid product shipment interruptions by implementing an enterprise-level solution that integrates and verifies product compliance to RoHS, REACH and other directives at every phase of product development. Topics include:

  • Today's regulatory landscape and how it affects the products devicemakers manufacture and sell in various global markets;
  • An overview of the data management challenge of determining and ensuring the compliance of device products;
  • The 3D Experience Platform and the Materials Compliance solution from Dassault Systèmes, and the business process and data flow that it enables; and
  • Customer success stories, with a particular focus on the success at AB SCIEX.

Presentation #1: Download the presentation

Speakers: George Valaitis, RoHS Program Manager with Global Responsibilities, AB SCIEX, and Jean Colombel, Vice President of the Life Sciences Industry, Dassault Systèmes

 
REMS 2014
88 minutes

Description: Legal expert Howard Dorfman provides an update on the status of the FDA's REMS requirements and the outlook for 2014. Dorfman discusses:

  • Required REMS elements;
  • Assessment time frame;
  • REMS and the innovator-generic debate; and
  • The revised Change Being Effected ("CBE") rule.

Presentation: Download the presentation

Speaker: Howard Dorfman, Vice President and General Counsel, Ferring Pharmaceuticals, Inc.

Description: Project management consultant David Harrison offers tips and techniques for validating spreadsheets quickly and efficiently while still maintaining compliance with FDA regulations. Topics include:
  • What the FDA expects from spreadsheet validation;
  • Determining user requirements;
  • Developing and reformatting spreadsheets; and
  • Documenting spreadsheet testing.

Presentation: Download the presentation

Handout #1: ABB Spreadsheet Validation Summary

Handout #2: Excel Spreadsheet Validation – Overview

Handout #3: Excel Spreadsheet Validation – Specification

Handout #4: Excel Spreadsheet Validation – Testing

Speaker: David Harrison, Principal Consultant, ABB Engineering Services

 
Description: Regulatory experts Daniel Kracov and Dan Pariser explain the FDA's November 2013 proposal for allowing generic drug manufacturers to use the same process as branded drug manufacturers when updating product labeling. Topics covered include:
  • Liability implications for both generic and branded manufacturers;
  • Current requirements for updating labeling;
  • Process for submitting labeling changes under the proposed rule; and
  • Whether legal challenges will delay issuance of a final rule.

Presentation: Download the presentation

Speakers: Daniel Kracov, head of the FDA and healthcare practice at Arnold & Porter LLP, and Dan Pariser, partner and specialist in healthcare product liability, Arnold & Porter LLP

 
Description: Pharmaceutical security specialists Robert Reznick and Elizabeth Howard share insight on building an anti-counterfeiting/product integrity program, with special focus on China's enforcement activities. They cover:
  • Varying definitions of counterfeit drugs;
  • U.S. legal issues and actions;
  • Using intellectual property laws to combat counterfeiting; and
  • How the Internet complicates the problem.

Presentation: Download the presentation

Speakers: Robert Reznick, Partner and Life Sciences Practice Co-Chair, Orrick, Herrington & Sutcliffe, and Elizabeth Howard, Partner and Intellectual Property Litigator, Orrick, Herrington & Sutcliffe

 
Description: Global drug safety expert Graeme Ladds teaches how to develop and maintain Company Core Data Sheets. Topics include:
  • Differences between Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI);
  • EU vs. U.S. interpretation of what to include in a CCSI; and
  • How and when to add to a CCSI.

Presentation: Download the presentation

Speaker: Graeme Ladds, CEO, PharSafer Associates Ltd.

 
Description: Bristol-Myers Squibb Principal Scientist Nancy Lewen discusses the status of global standards for testing of metals in drug product manufacturing. Lewen covers:
  • Problems with current testing methods;
  • How to determine what and when to test; and
  • Using a risk-based approach to testing.

Presentation: Download the presentation

Speaker: Nancy Lewen, Principal Scientist, Bristol-Myers Squibb

 
Description: Attorneys and medical device compliance specialists Anne Walsh and Allyson Mullen discuss pitfalls surrounding off-label promotion issues, covering such topics as:
  • How the FDA and the Federal Trade Commission share authority over advertising of medical devices;
  • Labeling vs. advertising; and
  • FDA enforcement tools.

Presentation: Download the presentation

Handout #1: Massager2000

Handout #2: Intradiscal Catheter

Handout #3: Highlights of Promotional Review Policy

Speakers: Anne Walsh, Director, Hyman Phelps and Allyson Mullen, Associate, Hyman Phelps

 
Description: Axel Wirth, National Healthcare Solutions Analyst for Symantec, brings an expert perspective to the issue of protecting devicemakers’ data from hacking and other cyber threats. Wirth covers:
  • The evolution of cyber threats;
  • FDA recommendations for medical devices;
  • Security systems available to the industry; and
  • Resources and references devicemakers can turn to for more information.

Presentation: Download the presentation

Speaker: Axel Wirth, National Healthcare Solutions Analyst, Symantec