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: 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
Recorded on: May 5, 2020
Description: Training experts Crissy MacDonald and Steve Whittaker discuss how unifying document management and training in a single platform ensures the traceability of training materials from creation to consumption, enabling closed-loop compliance. Topics include:
- How to address common challenges in building an effective GxP training program;
- Best practices of creating an enterprisewide learning strategy; and
- How a unified GxP training environment delivers better training and quality outcomes.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Crissy MacDonald, Vice President of Client Delivery, The Avoca Group and Steve Whittaker, Senior Consultant, The Avoca Group
Recorded on: April 30, 2020
Description: Training experts John Constantine and Kent Malmros discuss how unifying document management and training in a single platform ensures the traceability of training materials from creation to consumption, enabling closed-loop compliance. Topics include:
- How to address common challenges in building an effective GxP training program;
- Best practices of creating an enterprisewide learning strategy; and
- How a unified GxP training environment delivers better training and quality outcomes.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: John Constantine, Senior Vice President of Talent Solutions, Orchestrall, and Kent Malmros, Senior Director of Vault Training, Veeva Systems
Recorded on: April 23, 2020
Description: Regulatory expert Dan O’Leary discusses the postmarket surveillance (PMS) requirements under the upcoming EU-MDR. He covers:
- How to prepare your PMS plan;
- How to prepare other related plans — the complaint management plan, the trend report plan; and
- How to determine the reports required for the PMS system.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises
Recorded on: April 22, 2020
Description: Privacy and data protection attorney Stephan Grynwajc provides a comprehensive overview of the rules that apply to the collection of EU personal data and its use in clinical trials. He discusses:
- The GDPR, the ePrivacy Directive, the Clinical Trials Directive and the draft Clinical Trials Regulation;
- Adapting internal policies and procedures to comply with EU laws and regulations;
- Understanding international transfers of data under the 1995 Privacy Directive/GDPR and the interplay between the GDPR and the EU and Swiss Privacy Shield Frameworks; and
- EU privacy enforcement trends following the adoption of the GDPR.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Stephan Grynwajc, Managing Partner, Law Office of S. Grynwajc
Recorded on: April 21, 2020
Description: Medical device regulatory experts Kristin Davenport and Christina Kuhn explores the nuances of the FDA’s regulation and enforcement related to digital health tools. They discuss:
- Determining which FDA policies apply when wearables are regulated, including how to comply with the FDA’s guidances on clinical decision support;
- Specifying differences between platforms and individual apps; and
- Assessing considerations for artificial intelligence and the intersection of artificial intelligence and the FDA regulation.
Presentation: Download the presentation
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Speakers: Kristin Davenport, Of Counsel, Covington & Burling, LLP and Christina Kuhn, Associate, Covington & Burling, LLP
Recorded on: April 16, 2020
Description: Medical device regulatory expert Dan O’Leary presents best practices, processes and methods for compliant change management. He discusses:
- The overarching change management process and methods;
- How to apply the process to specific change types;
- Determining the change interactions in the change types; and
- Identifying the similarities and differences across quality management system requirements.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises