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: Jan. 17, 2018

Description: China regulatory expert Grace Fu Palma presents tips for preparing IVD premarket submissions to China’s food and drug authority. She covers:

  • CFDA IVD registration requirements and how they differ from FDA classifications;
  • How to prepare samples to pass local IVD approval tests;
  • Changes in the clinical trial exemption catalog; and
  • Changes in CFDA medical device supervision and monitoring in regard to registration of legal agents.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Grace Fu Palma, CEO, China Med Device LLC

Recorded on: Jan. 9, 2018

Description: Quality management expert Chris Thornton discusses cutting-edge ways to use digital technology for streamlining quality processes, consolidating systems, achieving full compliance and managing risk. He covers:

  • The impact Industry 4.0 and Internet of Things (IoT) has on the quality ecosystem;
  • Benefits and challenges of using cloud platforms and other digital innovations in the GXP-regulated environment; and
  • Augmenting quality strategy with cloud technology.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Chris Thornton, Director, Global Accounts, Sparta Systems

Recorded on: Dec. 20, 2017

Description: Device expert Thomas Shook discusses how the use of wearable devices and sensors can impact the world of clinical trials. He covers:

  • Best practices in use of sensors and wearables, including subject protection and data privacy;
  • How mHealth is changing data collection in clinical trials;
  • New types of health information now collectible with sensors; and
  • The regulatory impact of sensors and wearables.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Thomas Shook, Executive Vice President and Senior Medical Officer, PAREXEL

Recorded on: Dec. 14, 2017

Description: A panel of industry experts discusses the FDA’s plans and priorities for 2018 and beyond. They cover:

  • Opioids;
  • The new drug approval process;
  • FDA transparency; and
  • Orphan drugs and rare diseases.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Wayne Pines, President, Health Care, APCO Worldwide; Steven Grossman, President, HPS Group, LLC; and Brian E. Harvey, Principal Consultant, Brian E Harvey LLC

Recorded on: Dec. 6, 2017

Description: Device development expert Anthony Parise explains how to use risk management tools to secure your supply chain. He discusses:

  • How risk management tools can open new windows into compliance;
  • Leveraging risk in compliance, product performance and safety;
  • Risk management tools your competitors are using; and
  • Turning suppliers into compliance and quality partners.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Anthony Parise, Life Sciences Product Strategist, Verse Solutions

Recorded on: Dec. 5, 2017

Description: Biotech expert Keith Chidwick untangles the complexities of the new European Drug Assessment Policy for Biological Medicines. He discusses:

  • Eligibility and requirements to enter the centralized procedure;
  • Game-changing issues, including comparability, the main CMC reason for refusal;
  • Strategic validation; and
  • Best practices for biosimilars in the EU.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Keith Chidwick, Technical VP, PAREXEL Consulting

Recorded on: Nov. 28, 2017

Description: Regulatory compliance expert Paul Daniel presents five key considerations in deciding the best way to set up an enterprise-wide monitoring system. He discusses:

  • Multi-site security issues;
  • International monitoring challenges;
  • IT infrastructure considerations; and
  • Dealing with different types of sites within the same system.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Paul Daniel, Senior Regulatory Compliance Expert, Vaisala

Recorded on: Nov. 16, 2017

Description: A panel of experts discusses the regulatory outlook for drugmakers under the current administration. They cover:

  • Gottlieb’s big-picture approach to drug development;
  • Making the clinical end of drug development more efficient and effective;
  • Integrating real-world evidence in clinical and regulatory decisions; and
  • Initiatives to combat the opioid epidemic.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Wayne Pines, President, Health Care, APCO Worldwide; Douglas W. Balogh, Director, Navigant; Kevin Madagan, Partner, Reed Smith

Recorded on: Nov. 15, 2017

Description: Veeva Vice President Melonie Warfel and Solution Consultant Richard Chu discuss using systems that improve manufacturing processes without risking compliance pitfalls. They cover:

  • Managing, finding, and sharing critical content to enable internal and external collaboration with all critical stakeholders;
  • Providing real-time visibility into documents and processes, and gaining complete control over audits and inspections; and
  • Monitoring and reporting to mitigate compliance risks.

The webinar also includes a demonstration of Veeva’s Vault Suite.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Melonie Warfel, Vice President, Global Medical Device & Diagnostics, and Richard Chu, Solution Consultant, Veeva Systems

Recorded on: Nov. 14, 2017

Description: Quality systems expert Dan O’Leary parses two new final guidances on changes to 510(k) devices. He discusses:

  • The FDA’s plans for evaluation of changes;
  • Role of risk management (ISO 14971:2007) in the evaluation process; and
  • How to establish the quality record to support your decision.

Presentation: Download the presentation

Transcript: Download the transcript

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