The FDAnews Webinar Training Pass program offers year-round, unrestricted access to any of the hundreds of webinars listed below. These training programs feature thought leadership and best practices from top consultants, expert speakers and current and former FDA officials. New webinars are offered every month, along with access to the Webinar Training Pass archive.
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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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Webinar Training Pass
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
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
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
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
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
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
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
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
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Speaker: Robert Brooks, Phorum Leader, BioPhorum Supply Partner
Recorded on: May 25, 2021
Description: The presenters provide insight into how Pfizer delivered their safe, highly effective COVID-19 vaccine in less than a year — by treating the entire clinical development process as one protocol managed by one team — so you can, too. They’ll discuss:
- Why executive level support is essential in breaking down organizational barriers;
- How to compress cycle times using standardized metrics, machine learning, parallelization and other techniques;
- How risk management is critical to optimizations across the clinical trial continuum and is pivotal to balancing quality, cost and speed constraints; and
- How to centralize and coordinate activities across departments with technology, ultimately eliminating internal silos and building a team of one.
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Speakers: Ralph Russo, Senior Director and Global Head, Clinical Database Management Pfizer; Jonathan Rowe, Associate Principal, R&D Excellence, ZS Management Consulting; Keith Dorricott, MCC Ambassador, and Lead of the MCC Site Selection & Start-Up Process Metrics Development Work Group; and Elvin Thalund, Director, Industry Strategy, Oracle Health Sciences
Recorded on: May 20, 2021
Description: Thomas Altmann, global technical manager at Ecolab, will explain how cleaning processes can be evaluated using bench scale studies, sharing:
- How to improve or optimize cleaning processes using experiments;
- How to perform an assessment on all cleaning processes to determine the variable factors that influence cleaning effectiveness and performance;
- How laboratory bench scale studies can be used to identify an effective cleaning process; and
- How to evaluate lab trials and translate resulting data into manufacturing instructions and SOPs.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Thomas Altmann, Global Technical Manager, Ecolab