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, 2020
Description: Clinical researcher Marina Malikova examines how changes to the international good clinical practice guideline have affected trials. She discusses:
- New sections on investigator responsibilities and the substantial new sponsor section on quality management;
- Implementation of revised regulatory guidelines, including those affecting globalization issues;
- Introduction of risk-based quality management; and
- Development of SOPs, including those on validation and electronic records.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Marina Malikova, Assistant Professor of Surgery and Executive Director of Surgical Translational Research, Operations and Compliance, Boston University School of Medicine
Recorded on: May 21, 2020
Description: Supply chain experts Megan Biernat and Steve Tallant discuss Merck’s approach to supply chain security. They cover:
- How the company uses blockchain technology to create a secure link between physical and digital;
- How it leverages digital eFingerprint technology; and
- A next-generation approach to digitally protect and connect pharmaceutical products.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Megan Biernat, Technical Analyst, Merck, and Steve Tallant, Senior Director of Market Development, Systech
Recorded on: May 20, 2020
Description: Medical device regulatory experts Kim Young and Chris Nichols discuss ways to improve the efficiency of regulatory operations information management. They cover:
- How to integrate the critical aspects of EU-MDR compliance;
- What you must consider when deploying a sustainable EU-MDR compliance framework;
- How to avoid challenges and setbacks when searching for the right technology and tools; and
- Modernizing processes, technologies and tools.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kim Young, Instem Director of Global Regulatory Intelligence and Chris Nichols, Regulatory Solutions Specialist, Instem
Recorded on: May 19, 2020
Description: Clinical operations and compliance experts discuss methods for conducting trials under the current pandemic conditions. They cover:
- Shifting FDA and IRB guidelines;
- Technology options for supporting clinical trials; and
- Home health and direct-to-patient options.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kim Kundert, Vice President of Operations, VirTrial, Robin Marcus, Chief Strategy Officer, GlobalCare Clinical Trials and Melanie Flores, Vice President of Compliance, IntegReview
Recorded on: May 14, 2020
Description: Medical device expert Dan O’Leary discusses how Microsoft Excel can help predict outcomes. He covers:
- Using Excel to generate random numbers;
- Examining the relationship between probability density functions and cumulative density functions; and
- Applying Excel functions that can produce random numbers from various statistical distributions.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises
Recorded on: May 14, 2020
Description: Regulatory expert Allison Fulton discusses best practices in complaint management. She covers:
- Evaluate trends in regulatory enforcement;
- The importance of consistent complaint intake in measuring effectiveness; and
- Auditing the complaint management system.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Allison Fulton, Partner, Sheppard Mullin
Recorded on: May 13, 2020
Description:Quality systems expert Christy Mazzarisi shares the latest methods for employing AI and robotics to quality management. She discusses:
- How new technology decreases costs and increases employee engagement;
- How intelligent automation increases quality and productivity;
- Applying continuous improvement methods; and
- Interpreting different methods and metrics used in continuous improvement projects.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Christy Mazzarisi, Quality Lead, CGI
Recorded on: May 7, 2020
Description: eQMS solutions expert Panos Boudovas discusses the potential for the ROI of quality. He covers:
- Calculating an ROI of quality, including operational efficiencies, time-to-market for new products, audit and qualification processes, access to documents and data as well as improvements in product quality;
- Building a business case for an eQMS by benchmarking your current quality performance; and
- Choosing the right eQMS solution that will be able to grow and scale to meet evolving business needs over time.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Panos Boudovas, CEO, Founder, ZenQMS
Recorded on: May 6, 2020
Description: Safety and regulatory systems expert Jennifer Markey discusses allocating more resources to the sciences of signal detection, epidemiology and risk management. Topics include:
- Approaches and benefits to moving from operational to scientifically driven pharmacovigilance;
- Common challenges, including data quality and team skillset, and how to address them; and
- Advancements in modern technologies to drive operational efficiencies and streamline safety science.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jennifer Markey, Vice President of Vault Safety Strategy and Consulting, Veeva Systems
Recorded on: May 5, 2020
Description: Quality experts discuss drivers toward a cloud-based quality management system. They cover:
- On-site vs. cloud solutions;
- A variety of cloud models; and
- The emergence of cloud-based regulated systems.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Sandra Rodriguez, Market Analyst, Axendia, Joe Vigil, Director of Quality Management Systems, Ultragenyx, Mike Jovanis, Vice President of Vault Quality, Veeva Systems