The Webinar Training Pass

The 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.

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.

Many of our 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.

Already have an account?   Login Here.

Webinar Training Pass

Recorded on: Nov. 9, 2016

Description: Life sciences attorney Katy Van Pelt offers advice on how to facilitate communication between the regulatory affairs and sales group. Topics include:

  • Establishing a marketing review team, composed of sales and marketing, legal, and regulatory professionals that understand each other’s objectives and success standards;
  • Understanding how the latest compliance mandates intersect with current social media and traditional marketing approaches; and
  • Avoiding regulatory problems caused by the use of unapproved, non-compliant promotional materials by ensuring that your sales force gets the materials they need when they need them.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Katy Van Pelt, Partner, Potomac Law Group, Regulatory, Food & Drug, Healthcare, and Life Sciences Group

Recorded on: Oct. 31, 2016

Description: Veteran FDA consultant John Lincoln explains the revised ISO 13485’s focus on software verification and validation and outlines the FDA's preferred 11-element documentation model and how to apply it to different situations. Lincoln addresses:

  • What the FDA accepts as an appropriate documentation model;
  • New expectations for process and testing software; and
  • When and how to use DQ, IQ, OQ, PQ or their equivalents.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: John Lincoln, Principal, J.E. Lincoln and Associates LLC

Recorded on: Oct. 27, 2016

Description: Human reliability training expert Ginette Collazo shares strategies for reducing human error on the factory floor and demonstrates tools for improving human error systems and processes, and staff training. Topics include:

  • Causes of human error;
  • Five reasons human error isn't controlled;
  • Cognitive load; and
  • High reliability organizations.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Ginette Collazo, Ginette M. Collazo, Inc.

Recorded on: Oct. 26, 2016

Description: Life sciences attorney Alexander Varond provides an overview of the FDA’s Special Protocol Assessments program and the impact of new draft guidance on sponsors and regulatory affairs professionals. He discusses:

  • What content to include in your SPA;
  • How and when to optimally utilize SPAs to get feedback from the FDA on clinical trial design;
  • Circumstances in which the FDA might rescind an SPA agreement; and
  • Deadlines established by the FDA and how to avoid delays and lengthy negotiations.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Alexander Varond, Associate,Hyman, Phelps & McNamara

Recorded on: Oct. 25, 2016

Description: Cybersecurity experts Russell Jones and Nick Sikorski discuss how to conduct security risk assessments for connected medical devices and how to develop remediations to reduce risks to an acceptable level. They cover:

  • What threats have emerged as medical device functionality has grown;
  • The impact of the FDA’s recently released draft guidance on 510(k) submissions related to the design, development, maintenance, and disposition on connected medical devices; and
  • Where the industry may be going next regarding cybersecurity of connected medical devices.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Russell L. Jones, Partner, and Nick Sikorski, Senior Consultant, Deloitte & Touche LLP, Life Sciences & Healthcare Sector – Cyber Risk Services

Recorded on: Oct. 20, 2016

Description: Quality systems expert Dan O’Leary provides and in-depth explanation of the Quality System Regulation’s requirements for purchasing controls. He discusses:

  • Elements of supplier evaluation and selection;
  • Maintaining supplier records to demonstrate system effectiveness; and
  • The additional requirements in ISO 13485:2016.

Presentation: Download the presentation

Transcript: Download the transcript

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

Recorded on: Oct. 19, 2016

Description: Attorney Anna Laakmann explains how regulatory noncompliance can form the basis of a False Claims Act (FCA) enforcement action. She discusses:

  • How to avoid FCA claims based on promotion and marketing;
  • Common scenarios in which regulatory violations can give rise to FCA liability; and
  • What a qui tam action is and the role that employees and other whistleblowers play in enforcing the FCA against drug and device manufacturers.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Anna Laakmann, Of Counsel, Greenberg Traurig

Recorded on: Oct. 13, 2016

Description: FDA and industry experts discuss the effect UDI implementation will have on med-tech manufacturers, healthcare providers, regulators and ultimately the patient. Topics include:

  • The FDA’s intent to significantly improve device evaluation and decisionmaking through the adoption of UDI across the device ecosystem;
  • Opportunities to go beyond compliance and leverage UDI for the future;
  • The value of managing the device identifier (DI) and production identifier (PI) throughout the product lifecycle; and
  • Effects of UDI implementation in terms of post-market quality management and future innovation efforts, including precision medicine initiatives.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Terrie Reed, FDA Senior Advisor for UDI Adoption; Daniel R. Matlis, Founder and President, Axendia; and Jean Colombel, Vice President, Life Sciences Industry, Dassault Systemes

Recorded on: Oct. 12, 2016

Description: Clinical trial management experts Jason James and Vince Postill discuss the current and emerging demands on clinical trial supply, and how to design a supply chain that is fit for future challenges. They cover:

  • Developing an on-demand packaging model that meets country-specific regulatory and language labeling requirements;
  • Latest packaging and labeling technologies;
  • Data-driven label design and printing; and
  • Language and phrase management tools.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Jason James, Senior Manager, Labeling and Innovation, Bristol-Myers Squibb and Vince Postill, Senior Vice President, Global Product & Business Development, Prisym ID

Recorded on: Oct. 5, 2016

Description: Connectivity specialist Tim Gee provides insight into the current regulatory landscape for digital devices. He covers:

  • Market trends and government regulations, including the Joint Commission, FDA, and FTC guidance on mobile apps and other digital products;
  • How regulatory changes impact risk management, verification testing and the use of OTS components; and
  • Tactics and methods to ease the digital transformation and provide your company with a competitive advantage.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Tim Gee, Principal and Founder, Medical Connectivity Consulting