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.

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Webinar Training Pass

Recorded on: May 11, 2016

Description: Quality management systems specialist Scott Mitreuter demonstrates how to use innovative technology to streamline your quality metrics initiative. He discusses:

  • How metrics fit into the overall vision on quality programs;
  • How to implement the required quality metrics with internal company data used to monitor quality systems; and
  • What tools are available to capture and measure quality information from manufacturing sites, CROs and suppliers.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Scott Mitreuter, Product Management, Sparta Systems

Recorded on: May 10, 2016

Description: Trade law specialist Jennifer Diaz shares strategies on how to resolve FDA and Customs and Border Patrol (CBP) issues when importing medical products, cosmetics and foods. She covers:

  • Changes to the Cuban embargo;
  • New best practices for responding to liquidated damages claims from CBP;
  • Best practices for responding to being placed on the Import Alert List; and
  • Most effective tactics for getting your company off the Import Alert List.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Jennifer Diaz, Founding Partner, Diaz Trade Law, P.A.

The New FSMA Rules
70 minutes

Recorded on: May 5, 2016

Description: Food industry authority Erik R. Lieberman discusses key compliance issues related to the Food Safety and Modernization Act regulations and offers insight into FDA priorities for regulating and enforcing the comprehensive food safety law. Topics include:

  • Registration of food facilities and implementation of GMP standards;
  • How new GMP standards for food production affect manufacturers;
  • New provisions for warehousing and distribution; and
  • New provisions for defect action levels.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Erik R. Lieberman, Founding Principal, Lieberman PLLC

Recorded on: May 4, 2016

Description: Quality manufacturing expert Alexandre Alain discusses the potential causes for repeat CAPAs in an organization and ways to effectively reduce their occurrence. He covers:

  • How to leverage risk tools to break the cycle;
  • Effective strategies to ensure CAPAs are completed correctly;
  • How to link CAPAs to change control; and
  • How leveraging technologies and automated tools mitigate the risk of recurrence.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Alexandre Alain, Life Science Product Manager, VERSE Solutions

Recorded on: April 28, 2016

Description: Enforcement and regulatory experts Scott Bass and Bill McConagha discuss areas in which dietary supplement stakeholders face increasing liability and how they can mitigate that liability. They cover:

  • CEO and senior officer liability;
  • GMP awareness; and
  • Recent FDA and DOJ enforcement activities.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Scott Bass, Partner, and Bill McConagha, Partner, Sidley Austin LLP

Recorded on: April 26, 2016

Description: Quality systems expert Dan O’Leary explains recordkeeping requirements for medical devices and clarifies the differences between the Device Master Record, the Device History Record and the Quality System Record. He discusses:

  • ISO 13485:2016
  • Unique Device Identification requirements; and
  • Special cases, such as Class I devices and specification developers.

Presentation: Download the presentation

Transcript: Download the transcript

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

Recorded on: April 25, 2016

Description: Quality assurance expert Susan Schniepp discusses how to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites. She covers:

  • Planning and project management;
  • Transfer of analytical assays;
  • Small-scale verification at receiving site; and
  • Pre-GMP engineering runs.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Susan J. Schniepp, Fellow, Regulatory Compliance Associates, Inc.

Recorded on: April 21, 2016

Description: Biosimilars expert Nathan Doty examines the outlook for the industry and discusses:

  • Immunogenicity;
  • Loss of efficacy; and
  • Switching without interchangeability.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Nathan Doty, Associate Director, Biotherapeutics Regulatory Affairs, Abbvie

Recorded on: April 20, 2016

Description: Clinical trial policy advisor Beverly Lorell discusses how to keep your focus on data collection and integrity. Topics include:

  • Inadequate recordkeeping;
  • Inadequate accountability for the investigational product;
  • Inadequate communication with the IRB;
  • Inadequate subject protection — failure to report AEs and informed consent issues; and
  • Inadequate monitoring.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Beverly Lorell, Senior Medical and Policy Advisor, FDA & Life Sciences Practice Group, King & Spalding

Recorded on: April 13, 2016

Description: Regulatory specialist Michele Buenafe discusses the current regulatory climate for mobile medical apps, issues that are yet to be resolved and expectations for future developments and the direction of regulatory policy in this space. She covers:

  • Mobile medical apps guidance;
  • FDASIA Health IT Report;
  • FDA enforcement discretion; and
  • FTC enforcement.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Michele Buenafe, Partner, FDA Practice, Morgan, Lewis & Bockius, LLP