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.
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.
Search by keyword, speaker name or just by category (drug, device or clinical) and you'll find all you need.
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Webinar Training Pass
Recorded on: July 30, 2020
Description: Blockchain technology specialist James Canterbury explains the core tenets of distributed systems, blockchains and cryptography in quality and compliance processes. He discusses:
- Where blockchains are currently being used in the pharmaceutical industry, including manufacturing and the supply chain;
- The core components of blockchain technology, including single-source data integrity;
- Public vs. private blockchains and the challenges, advantages and disadvantages of each; and
- How to use a blockchain as a notarization system.
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Speaker: James Canterbury, Partner, Ernst & Young
Recorded on: July 29, 2020
Description: UDI expert Jay Crowley shares ways to manage multiple regulatory bodies, best practices around establishing and maintaining robust and effective global UDI processes, possible responses to distinct local UDI concerns and how to submit identification product data to various stakeholders. Topics include:
- The evolution of UDI guidelines;
- Intertwining regulatory, commercial and patient safety information;
- Initial development, maintenance and reuse of information; and
- EU UDI requirements, including EUDAMED expectations.
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Speaker: Jay Crowley, Vice President, Unique Device Identification Solutions and Services, USDM Life Sciences
Recorded on: July 29, 2020
Description: Risk management expert Amanda McFarland discusses applying risk-based quality management decisionmaking to ensure the long-term impacts of your company’s current decisions are fully understood. She covers:
- Ways to integrate risk management into your quality systems;
- The PIC/S Aide-Memoire on quality risk management and how to prepare for an inspection; and
- Risk management tools available, such as process hazard analysis (PHA), risk evaluation and mitigation (REM), hazard analysis critical control point (HACCP) and FMEA.
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Speaker: Amanda McFarland, QRM and Microbiology Senior Consultant, ValSource
Recorded on: July 23, 2020
Description: Clinical trial privacy experts Sarah Lyons and Vivien Fagan explain how to build brand trust through clinical trial transparency, navigate evolving transparency regulations and protect patient privacy when sharing clinical trial data. They discuss:
- Current transparency requirements for study publication from the FDA, EMA and Health Canada;
- The link between transparency, privacy and brand trust, and how privacy-preserving data-sharing methods can help sponsors earn trust with internal and external stakeholders, including patients themselves;
- Best practices for anonymization to enable trial transparency while protecting participant privacy, including quantitative re-identification risk measurement; and
- Preserving data utility and protect patients when sharing data voluntarily.
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Speakers: Sarah Lyons, General Manager of Privacy Analytics, and Vivien Fagan, Director of Medical Writing and Clinical Trial Disclosure, IQVIA
Recorded on: July 22, 2020
Description: Regulatory expert Scott Burger presents best practices for determining the necessary level of comparability studies, planning and preparing for analysis, and avoiding common mistakes in a package for the FDA. He covers:
- Determining the necessary rigor of a comparability study;
- Using the right analytical tools, samples, and statistical analyses;
- In vitro versus in vivo comparability studies; and
- Common mistakes and how to avoid them.
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Speaker: Scott Burger, Principal, Advanced Cell and Gene Therapy
Recorded on: July 16, 2020
Description: Medical device regulatory expert Dan O’Leary discusses how to meet the technical and regulatory requirements for inspection, measuring and test equipment. He covers:
- Definitions and examples of accuracy, precision and traceability;
- The requirements of FDA QSR and ISO 12485:2016;
- The effective use of quality audits and international quality audit programming; and
- Quality agreements covering outsourced processes.
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Speaker: Dan O’Leary, President, Ombu Enterprises
Recorded on: July 16, 2020
Description: Learning strategy specialists John Constantine and Kent Malmros discuss the benefits of micro-learning and a practical approach to applying it into your existing GXP training program. The cover:
- How micro-learning can boost your GxP training compliance;
- How to overcome the common misconceptions about micro-learning; and
- How to implement micro-learning into your GxP training program.
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Speakers: John Constantine, Senior Vice President of Talent Solutions, Orchestrall, and Kent Malmros, Senior Director, Vault Training at Veeva Systems
Recorded on: July 15, 2020
Description: Statistical methods expert Steven Walfish presents tools for developing statistical sampling plans. He covers:
- The differences between confidence and reliability in the sample size;
- Incorporating statistical assumptions, such as independence, as part of all sampling plans; and
- How variance in the population impacts the sample size necessary to establish objective evidence.
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Speaker: Steven Walfish, President, Statistical Outsourcing Services
Recorded on: July 15, 2020
Description: Pharma regulatory expert Pradip Banerjee shows how to use risk-prediction software, benchmarking and new robotic process automation software cloud platform using AI and machine learning algorithms. He covers:
- How to move compliance risk and quality management processes into the cloud with full integration with operating systems;
- How to create a strategic digital future workplace with proactive automated real-time compliance monitoring, AI-driven compliance risk prediction and mitigation to enable continuous data integrity and eChain of custody of information in real time; and
- How to improve informed executive decisionmaking by implementing compliance risk management.
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Speaker: Pradip Banerjee, CEO, Xybion
Recorded on: July 14, 2020
Description: Regulatory expert Jon Gimbel presents best practices for meeting postmarket requirements of the new EU-MDR. He discusses:
- Elements of required postmarket reports;
- Linking all reports so they can be updated together; and
- Common Notified Body audit findings.
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Speaker: Jon Gimbel, Executive Director, Regulatory and Quality Systems