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: Sept. 17, 2020
Description: Quality systems expert Dan O’Leary explains how to use analysis of variance (ANOVA) principles to examine quality data: He discusses:
- The underlying idea that makes ANOVA work;
- The data collection issues you should plan;
- How to get access to ANOVA in Excel; and
- Interpreting the result.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises
Recorded on: Sept. 17, 2020
Description: Computer system validation expert David Harrison shares best practices and available options for validating spreadsheets. He discusses:
- FDA examples of noncompliance and regulatory concerns with respect to 21 CFR 210-211, 21 CFR Part 11 and 21 CFR Part 820;
- How to determine spreadsheet validation gaps the FDA targets;
- How to choose an approach for efficient and repeatable validation that fits into your traditional QA and validation processes; and
- How to plan, manage and resource an effective project.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: David Harrison, Principal Consultant, CSV Compliance
Recorded on: Sept. 16, 2020
Description: Top officials of the Clinical Trials Transformation Initiative (CTTI) share the organization’s 10-year plan for strengthening trials’ evidence generation abilities. They discuss the five points of CTTI’s strategy:
- Patient-centered and accessible;
- Fully integrated with health processes;
- Designed with a quality approach;
- Maximally leveraging available data; and
- Improve public health.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Pamela Tenaerts, Executive Director, and John Alexander, Co-Chair, Clinical Trials Transformation Initiative
Recorded on: Sept. 16, 2020
Description: Data analysis experts Angela Slocum and Mitesh Devarapally discuss technology platform solutions for improving data quality and access. Takeaways include:
- Processes for defining data review objectives in today’s data chaos environment;
- How a centralized clinical data platform and analytics can be used to support data review objectives; and
- Best practices for adapting data review processes to a centralized data platform and workbench.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Angela Slocum, Senior Director of Implementation Consulting, and Mitesh R. Devarapally, Principal Medical Data Reviewer, eClinical Solutions
Recorded on: Sept. 15, 2020
Description: Clinical trial data specialist Ken Lownie shares key insights from Agatha Life Science’s State of Remote Monitoring survey. He discusses:
- The imperatives driving remote monitoring as a practice;
- Understanding the technology alternatives; and
- Calculating the costs and savings of remote monitoring.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Ken Lownie, Head of North American Operations, Agatha Life Sciences
Recorded on: Sept. 10, 2020
Description: A team of life sciences regulatory experts explores the expanded access terrain, provides an update on current regulatory changes and addresses possible policy solutions. Topics include:
- The existing legal and regulatory landscape driving expanded access;
- Recent congressional changes and how the FDA is implementing those changes;
- The FDA’s voluntary efforts to increase use of expanded access; and
- Policy considerations underlying the expanded access debate, such as monitoring and tracking of expanded access outcomes and adverse events.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: David Farber, Lisa Dwyer and Preeya Pinto, Partners, King & Spaulding
Recorded on: Aug. 20, 2020
Description: Device regulatory expert Dan O’Leary explains the new harmonized coding system and form for adverse event reporting. He covers:
- The code set structures;
- Planned changes to the FDA’s reporting form;
- The relationship between the IMDRF codes and the current FDA codes; and
- The EU Manufacturer’s Incident Report (MIR) and the IMDRF codes it uses.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises
Recorded on: Aug. 20, 2020
Description: A panel of quality experts discusses a practical approach to harmonizing quality processes that help accelerate technology implementation and adoption. Topics include:
- A proven framework for harmonizing business processes;
- Guidance on navigating complex organizations to gain support; and
- Best practices for transforming quality management systems.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Paola DePaso, Director, Vault Quality, Veeva Systems; Jan Paul Zonnenberg, Partner, Pharmaceutical & Life Sciences Companies, PwC; Anastasia Wengrowski, Manager, Vault Quality, Veeva Systems; and Vishaka Rajaram, Director, Pharmaceutical & Life Sciences Companies, PwC
Recorded on: Aug. 19, 2020
Description: Microbial control expert Jim Polarine shares tips on how to best design a risk-based cleaning program during this global health crisis. He discusses:
- Industry trends;
- Global regulatory expectations; and
- Frequency of cleaning and disinfecting.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jim Polarine, Senior Technical Service Manager, STERIS Corporation
Recorded on: Aug. 13, 2020
Description: Data analytics experts Mary Jo Lamberti and Francis Kendall discuss primary uses of real-world data (RWD) to generate evidence. They cover:
- Types of technology used to access or collect RWD;
- Significant challenges to using RWD as well as strategies and practices that impact return on investment or performance; and
- Regulators’ position regarding COVID-19 studies.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Mary Jo Lamberti, Professor, Tufts University, and Francis Kendall, Senior Director, Cytel