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. 30, 2020
Description: Regulatory affairs experts Kim Young and Monir El Azzouzi discuss the direct impact of UDI data requirements for multiple stakeholders and approaches considered across the industry to implement systems and processes. They cover:
- Implications for manufacturers of increased visibility by regulators;
- Compliance timelines of various UDI initiatives underway around the world; and
- How to leverage UDI data to drive internal regulatory intelligence.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kim Young, Director of Global Regulatory Intelligence, Instem, and Monir El Azzouzi, CEO, Easy Medical Device
Recorded on: Sept. 30, 2020
Description: Medical device regulatory experts Seth Olson and Susan Tiedy-Stevenson present the different FDA pathways to premarket approval. They discuss:
- 510(k), De Novo, PMA and EUA considerations;
- The effect of the newly proposed VALID Act;
- Software as a medical device; and
- FDA presubmission programming and strategies for informal modes of communication.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Seth Olson, FDA Medical Device Attorney, Susan Tiedy-Stevenson, Senior Director of Regulatory Sciences, Hogan Lovells
Recorded on: Sept. 29, 2020
Description: GMP compliance expert Sabine Paris discusses cleaning validation requirements set by the FDA and EU authorities for permitted daily exposure (PDE). She covers:
- The new requirements of EMA, PIC/S and ASTM PDE guidelines;
- The complex derivation of PDEs;
- Important aspects of PDE reports; and
- The risk identification in a multipurpose facility.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Sabine Paris, Pharmacist, Senior GMP Expert, Chief Editor of GMP Compliance Adviser
Recorded on: Sept. 24, 2020
Description: Regulatory compliance expert Kalah Auchincloss shares her insights on FDA inspections during the pandemic. She discusses:
- Developments in FDA inspections from March 2020 to July 2020;
- The agency’s August 2020 inspections guidance; and
- What the FDA’s inspection plans are going forward.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Kalah Auchincloss, Senior Vice President and Deputy General Counsel, Greenleaf Health
Recorded on: Sept. 24, 2020
Description: R&D expert Pradip Banerjee discusses how to unify all quality compliance and operating processes. He covers:
- Rapid quality transformation imperatives;
- New operating model for Web X.0 World; and
- Case examples.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Pradip K. Banerjee, Chairman of the Board and Chief Executive Officer, Xybion
Recorded on: Sept. 22, 2020
Description: Quality systems expert Tim Fischer discusses the concept of Quality 4.0 and what it entails. He covers:
- Digital transformation initiatives;
- Operational tools; and
- A digital system strategic roadmap.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Tim Fischer, Principal Partner, Great Solutions
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