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Home » Webinars

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.

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BUY NOW Single-User 1-Year Unlimited Access $1,297

Also available: Take advantage of our multi-user and site licenses of the Webinar Training Pass, so you’ll have the most-informed workforce! Contact Will Tuttle, Business Development Representative at wtuttle@fdanews.com or +1 612.216.2948 to receive a custom quote.

Search by keyword, speaker name or just by category (drug, device or clinical) and you'll find all you need.

If you have any questions or are having any problems please give us a call on 703.538.7600 or email customer service.

Webinar Training Pass

Decentralized Clinical Trials: Benefits of a Better Patient Experience
63 minutes

Recorded on: July 13, 2021

Description: SoftServe experts provide a fundamental framework for setting up and scaling the digital technologies your need to successfully engage patients remotely and safely generate and protect participant data. This webinar covers:

  • The increased need for and benefits of decentralized trials;
  • Improved data and privacy;
  • How to avoid costly consequences of unsuccessful trials; and
  • Ways to incorporate digital technology.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Steve LoSardo, Vice President, Life Science Solutions and Consulting, SoftServe; and Mariya Boychuk, Senior Business Analyst for Healthcare Solutions, SoftServe

Real-World Lessons from Companies Navigating the Challenges in Achieving EU-MDR Certification
61 minutes

Recorded on: July 8, 2021

Description: Using real-world lessons from companies who have already gone through the process, this webinar will provide you with a detailed understanding of the EU-MDR requirements and regulations, including:

  • What to know about expected challenges during the transition;
  • Where to focus and prioritize in the EU-MDR certification process;
  • Coordinating and planning around your Notified Body; and
  • Balancing the Technical file and QMS audit review.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Linda L. S. Lovett, CEO of Lovett Consulting

FDA’s Plan to Modernize the 510(k) Pathway: What Regulatory, Quality and Compliance Professionals Need to Know
83 minutes

Recorded on: June 22, 2021

Description: Mary Vater shares current best practices and tips for submitting 510(k)s, the FDA’s changes and how to keep your 510(k)s on track, explaining:

  • Specific changes the FDA made to the 510(k) process;
  • How to identify suitable and favorable predicate devices;
  • How to select a predicate with a relatively clean history; and
  • What FDA 510(k) pilot programs are currently underway.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Mary Vater, Consultant, Medical Device Academy

Accelerate the Startup of Your Clinical Trials Without Sacrificing Quality: Common Pitfalls that Cause Delays and How to Avoid Them
62 minutes

Recorded on: June 17, 2021

Description: The expert speakers explain the latest insights gleaned from Operation Warp Speed that accelerated vaccines and treatment for COVID-19. They’ll share:

  • An overview of current clinical trial performance, including common pitfalls that impact startup cycle times in clinical research;
  • How to address some of the startup cycle time challenges — without sacrificing quality; and
  • How to turn those key pitfalls into opportunities for improvement using an innovative solution which leverages the results of vendor qualification to reduce cycle times and resources in trial initiation.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Lee Jones, President, Diligent Pharma; Ken Getz, Director and Professor, Tufts University School of Medicine; and Jay Turpen, Head of Client Services, Diligent Pharma

Create a Quality Culture to Aid Risk Management: Dynamic Behaviors that Achieve Quality and Business Objectives
89 minutes

Recorded on: June 15, 2021

Description: The experts share how to recognize the behaviors that shape a healthy quality culture, how to diagnose and measure the health of your organization’s quality culture by explaining:

  • The importance quality culture in life sciences as described by the FDA;
  • The research-based behavioral model of quality culture in life sciences;
  • The interdependency of quality culture, quality management systems (QMS) and risk management and how these systems and observed beliefs/behaviors influence effectiveness and desired outcomes; and
  • How to apply this model to measure and diagnose the current quality culture of a life science organization.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Teresa Gorecki, Practice Director, Compliance Architects; and Kenneth Ray, Principal Consultant, Kenneth G Ray, LLC

Rethinking the Life Sciences Training Technology Ecosystem: Can the Agency Reconcile ICH, PICS & Domestic Manufacturing Initiatives During a Pandemic?
61 minutes

Recorded on: June 15, 2021

Description: Take a step back from the day-to-day and understand the entire training technology ecosystem. You’ll learn:

  • How technology makes the training function more strategic;
  • How technology helps design, develop, and deliver training to your learners;
  • How to prioritize acquiring new technologies and eliminating legacy solutions; and
  • Key tips for effectively implementing an LMS within your organization.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Kent Malmros, Sr. Director of Vault Training, Veeva Systems

FDA’s Big Global Quality Harmonization Dilemma: Can the Agency Reconcile ICH, PICS & Domestic Manufacturing Initiatives During a Pandemic?
76 minutes

Recorded on: June 10, 2021

Description: Howard Sklamberg shares how recent cooperation in inspections, regulator focus on global supply chains and other harmonization efforts will affect you. He explains:

  • The future of the U.S.-EU Mutual Recognition Agreement and what it means for inspections;
  • The long-lasting effects of FDA’s guidance on inspection alternatives during the pandemic;
  • How the CARES Act provisions on the supply chain will affect harmonization and how companies should prepare; and
  • The effect of pharmaceutical onshoring initiatives in the U.S. and Europe on harmonization efforts and what that means for manufacturers.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Howard Sklamberg, Partner, Arnold & Porter

Using AI for CAPA and Root Cause Investigation
62 minutes

Recorded on: June 8, 2021

Description: This webinar details how artificial intelligence (AI) can play an important role in quality management through connected quality data. You’ll learn:

  • How to effectively connect quality data;
  • The production problems that can be solved using AI;
  • The future of quality management; and
  • The benefits of using AI in your development process, including a quicker and more efficient quality management process.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Sue Marchant, Director, MasterControl

Evolving Clinical Trials: Continuing the Journey from Paper to Digital
45 minutes

Recorded on: May 27, 2021

Description: Optum experts share how moving to a technology-centered practice can help you achieve better results and how to make that transition smoother and more effective. They’ll cover:

  • Key clinical research challenges;
  • New approaches to addressing clinical research struggles; and
  • Examples of how a technology-focused approach can impact the research process.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Peter Payne, Vice President & Head, Optum Digital Research Network; and Tracy Ohrt, Clinical Operations Manager, Optum Digital Research Network

Biopharmaceutical Supply Chain Issues Before, During and After the Pandemic: Impact on the Pharmaceutical Industry’s Regulatory, Quality and Compliance Professionals
83 minutes

Recorded on: May 26, 2021

Description: In this webinar, Robert Brooks, PhD, phorum leader for BioPhorum Supply Partner, shares how to harness COVID-era — and post-COVID — supply requirements, so you can speed up the supply chain, explaining how to:

  • Develop a joint audit program approach to improve the overall quality assessment of the in-bound supply chain and reduce the overall cost for biomanufacturers and suppliers;
  • Better plan for demand while developing more useful risk management mitigation strategies to increase productivity and lower cost;
  • Recognize what the supplier industry is focused on doing to alleviate long-term surety of supply issues by increasing capacity of supply sites from multiple sources and how the biomanufacturing industry can help; and
  • Accept X-ray sterilization as a viable alternative to gamma irradiation for single-use systems, driving a supply-change notification approach and subsequent change impact assessment and validation package for the industry.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Robert Brooks, Phorum Leader, BioPhorum Supply Partner

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