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Webinar Training Pass
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
Get Ready for ICH E6(R3): How to Prepare When You’re Still Struggling to Adopt ICH E6(R2)
61 minutes
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
EU Clinical Trials Privacy
98 minutes
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
Transcript: Download the transcript
Speakers: Kristin Davenport, Of Counsel, Covington & Burling, LLP and Christina Kuhn, Associate, Covington & Burling, LLP
Medical Device Change Management
90 minutes
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
EU-MDR: Are You Ready? Part 2: Tips for Assessing Your Readiness Prior to Notified Body Review
86 minutes
Recorded on: April 10, 2020
Description: Device compliance expert Dan O’Leary discusses steps to prepare for notified body review under EU-MDR. He covers:
- Auditing quality management system elements;
- Requirements for the Annex IX application;
- The notified body document review process; and
- Understanding the notified body audit based on Annex VII.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises
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