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

Recorded on: Feb. 19, 2019

Description: Attorney and pharmacist Lee Rosebush addresses newly proposed standards for outsourcing. He discusses:

  • Implementing best practices to protect against contamination;
  • Ensuring that a compounder conducts sterility assurance activities for sterile products and microbiological quality activities for non-sterile products; and
  • Conducting annual quality standard evaluations of drug products.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Lee H. Rosebush, Partner, Baker Hostetler

Recorded on: Feb. 14, 2019

Description: Regulatory experts Nicholas Mitrokostas and Daniel Orr discuss recent developments in regulation of biosimilars. They cover:

  • Modernizing policies governing the development of biosimilars to make it more efficient;
  • Educating clinicians, payers and patients about biosimilar products and the rigorous evaluation they must go through; and
  • Modernizing regulatory policies to accommodate new scientific tools that better enable comparison between biosimilars and reference products that may reduce the need for clinical studies.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Nicholas Mitrokostas, Partner, Goodwin Procter LLP, and Daniel Orr, Partner, Womble Bond Dickinson LLP

Recorded on: Feb. 13, 2019

Description: Supply chain consultant Evren Ozkaya explains how to prepare for upcoming serialization and track-and-trace requirements. He discusses:

  • Lessons learned from the first five years of implementation of the Drug Supply Chain Security Act;
  • How to setup the right foundation for digital supply chain management; and
  • New technologies (e.g., Blockchain, Internet of Things) that will define supply chain capabilities.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Evren Ozkaya, Founder & CEO, Supply Chain Wizard, LLC

Recorded on: Jan. 30, 2019

Description: Regulatory expert James Rogers explores the nature and regulation of software as a medical device (SaMD). He discusses:

  • The process for classifying an SaMD based on U.S. and international guidance;
  • How a company’s use of a software product impacts the classification of SaMD;
  • When a purchased software product becomes an SaMD; and
  • Remediation approaches to resolve SaMD compliance issues.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: James Rogers, Founder, Compass Life Science Solutions

Recorded on: Jan. 29, 2019

Description: Regulatory expert Tiffany Guckin explains the nature and content of investigator’s brochures (IB) and IND annual reports. She discusses:

  • The importance of annual reports to the FDA and sponsors;
  • Structure and content of an IB per ICH E6 (R2);
  • How to ensure you are accurately representing your investigation to potential subjects; and
  • Best practices that can be included in SOPs or other regulatory processes.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Tiffany Guckin, Associate Director of Regulatory Affairs, Invicro

Recorded on: Jan. 17, 2019

Description: Regulatory expert Keith Webber discusses new ICH guidances being developed. He covers:

  • The nuances in global harmonization of the biopharmaceutics classification system for requesting biowaivers under ICH M9;
  • What to expect for the global harmonization of bioanalytical method validation under ICH M10; and
  • Why the ICH Q12 guideline is a game-changer for pharmaceutical regulatory and quality professionals.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Keith Webber, Vice President of Biotechnology, Lachman Consultant Services, Inc.

Recorded on: Jan. 15, 2019

Description: Cybersecurity expert Norma Krayem discusses the rapidly changing global IT security regulatory landscape. She covers:

  • Cybersecurity-triggered changes in the interpretation of HIPAA and enforcement by the HHS Office of Civil Rights;
  • Cybersecurity as an enterprise risk management issue affecting security, risk and privacy functions in device firms;
  • FDA’s evolving focus on cybersecurity and how it impacts the risk, responsibilities and regulation of companies; and
  • The Cybersecurity Information Sharing Act (CISA) and the Protected Critical Infrastructure Information (PCII) as potential “safe harbors.”

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Norma Krayem, Senior Policy Advisor and Co-Chair, Cybersecurity and Privacy Team, Holland & Knight

Recorded on: Jan. 10, 2019

Description: GMP expert Dan O’Leary explains how to collect samples of records for an audit. He discusses:

  • Concepts of sampling applied to quality audits;
  • The difference between a nonconformance and nonconformities;
  • The use of (non-statistical) convenience samples; and
  • The role of the binomial distribution in audit sampling.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Dan O’Leary, President, Ombu Enterprises

Recorded on: Dec. 18, 2018

Description: Attorneys Stephanie Resnik and Christopher Hanson outline the FDA’s new medical device voluntary malfunction disclosure program. They discuss:

  • How the program differs from individual malfunction reporting;
  • How the program will help increase devicemakers’ efficiency; and
  • Conditions under which the program is not available to manufacturers.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Stephanie Resnik and Christopher Hanson, Associates, Covington & Burling LLP, Washington, DC

Recorded on: Dec. 12, 2018

Description: Quality systems experts Mike Jovanis and J.P. Zonnenberg explain how modern solutions can lead to more informed quality decisions and faster innovation. They discuss how technology can:

  • Support the shift from compliance to product and patient focus;
  • Enable greater insight and better decisionmaking;
  • Seamlessly engage stakeholders across the development lifecycle; and
  • Transform business process for real-time responsiveness.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Mike Jovanis, VP, Vault Quality, Veeva Systems; J.P. Zonnenberg, Partner, Co-Lead, Quality Management Systems Practice, PwC