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.
BUY NOW Single-User 1-Year Unlimited Access $1,362
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.
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 Russ Titsch, Business Development Director at russ.titsch@wcgclinical.com or +1 703.538.7651 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
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
Transcript: Download the transcript
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.
Presentation: Download the presentation
Transcript: Download the transcript
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
Recorded on: May 19, 2021
Description: Two members of King & Spalding’s FDA and Life Sciences practice give you an overview of the ASCA pilot, show you how to conform to it and use it to your advantage, explaining:
- Who may participate in the ASCA pilot;
- Pros and cons of participating;
- What participants can expect;
- Implications of the ASCA pilot moving forward; and
- What information is made available on pilot participants.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Quynh Hoang, Senior Regulatory Consultant in the FDA and Life Sciences practice at King & Spalding; and Elaine Tseng, artner in King & Spalding’s nationally recognized FDA and Life Sciences
Recorded on: May 6, 2021
Description: This webinar explains what’s coming, identifies the constraints and power shifts within the biotechnology industry and clarifies how you can adjust now so you can move ahead. You’ll learn:
- What clinical trials will look like after the safety restrictions are lifted;
- Which trends will not survive (but should!); and
- Who will call the shots when trials restart.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: James Allgood, Product Marketing, Egnyte for Life Sciences
Recorded on: May 5, 2021
Description: Natalie Weber, a quality engineer at MasterControl, Inc., explains the new landscape of remote audits, clarifying:
- How to achieve the same goals during remote audits;remote audits are conducted and what they include;
- Why digitizing is the only way to perform remote audits; and
- Regulators’ attitudes toward remote audits.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Natalie Weber, Quality Engineer, MasterControl, Inc.
Recorded on: April 21, 2021
Description: Two lawyers in Ropes & Gray’s Life Sciences Regulatory and Compliance practice explain what can be gleaned from the forthcoming pandemic-influenced guidances impacting drug development, real-world evidence and digital health. They’ll discuss:
- Regulatory framework for biosimilars and possible changes with planned FDA guidance addressing labeling, promotion, interchangeability and exclusivity;
- Drug exclusivity framework and possible changes with planned FDA guidance addressing 180-day exclusivity, pediatric exclusivity and three-year exclusivity;
- Current state of real-world evidence in drug development, key open questions and planned FDA guidance addressing regulatory considerations with the use of real-world data to support FDA decision-making for drugs and biologics; and
- Emerging topics related to drug development and anticipated FDA guidance addressing decentralized clinical trials, substantial evidence and breakthrough therapy designation.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kellie Combs, Partner, Ropes & Gray’s Life Sciences Regulatory and Compliance Practice; and Sarah Blankstein, Senior Associate, Ropes & Gray’s Life Sciences Regulatory and Compliance Practice
Recorded on: April 15, 2021
Description: This webinar will help you determine whether an eTMF system is the right choice for your team. Through expert advice and tips, you’ll gain insights into:
- The five signs of eTMF readiness;
- eTMF features and functions;
- Predictors of eTMF success;
- The time and money savings from an eTMF; and
- Building support for an eTMF initiative.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Ken Lownie, Head of North American Operations, Agatha
Recorded on: April 8, 2021
Description: With this webinar, you’ll be able to determine the differences between traditional medical device regulations and software as a medical device (SaMD) regulations. It covers:
- The unique and novel risks software-intensive medical devices pose to the healthcare system;
- Difficulties and benefits that can come from SaMD versus 510(k) compliance;
- How automated RegOps could reduce preparation time for FDA submissions; and
- How building regulatory practices directly into the systems development lifecycle could ease inspection and audit burdens.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Shahid Shah, Founder of Netspective Communications