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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Search by keyword, speaker name or just by category (drug, device or clinical) and you'll find all you need.
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Webinar Training Pass
Recorded on: July 14, 2021
Description: Michael Meighu, PhD — a life science specialist with more than 20 years of experience in the field, focusing on AI and data science — translates AI and machine learning (ML), sharing:
- What natural language processing (NLP) is and how it can help you;
- An understanding of neural networks and deep learning and how you can put them to use;
- What AI open source is and how can it assist in developing prototypes or proof of concepts in the medical product space; and
- An understanding of python and fast.ai toolkits and ways to incorporate them.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Michael Meighu, PhD, Life Science Specialist and Justo Rodriguez, PhD, Data Scientist
Recorded on: July 13, 2021
Description: Greenleaf Health, Inc. experts share how to implement strategic engagement and planning and develop a quality and compliance strategy that aligns with CBER’s regulatory expectations, explaining:
- The relevance of CBER’s four overarching goals for FY 2021-2025;
- What you must understand about CBER’s four priorities that will inform its policy decisions for the next five years; and
- An analysis of the role CGT and personalized medicine development, advanced manufacturing technologies and AI/ML, RWE and RWD will play in CBER’s strategic and regulatory activities.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kalah Auchincloss, Senior Vice President and Deputy General Counsel, Greenleaf Health, Inc.; Madeleine Giaquinto, Manager of Regulatory Affairs, Greenleaf Health, Inc.; and Kate Cook, Principal, Regulatory Policy, Greenleaf Health, Inc.
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
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
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