Now get all the training you need – all in one place, and all for one low price!
The FDAnews Webinar Training Pass program gives you year-round unrestricted access to any of the hundreds of webinars listed below. These training programs feature top consultants, expert speakers and FDA officials.
PLUS, subscribers get automatic access to all our new training programs for the next 12 months – that’s more than 50 new programs a year!
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.
BUY NOW 1-Year Unlimited Access $1,297
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: 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.
Presentation: Download the presentation
Transcript: Download the transcript
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.
Presentation: Download the presentation
Transcript: Download the transcript
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.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises
Micro-Learning, Macro-Compliance: Improving GxP Compliance with Modern Learning Techniques
63 minutes
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.
Presentation: Download the presentation
Transcript: Download the transcript
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.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Steven Walfish, President, Statistical Outsourcing Services
Predictive Compliance Risk & Quality Management: A New Digital Paradigm for the Post-COVID-19 World
54 minutes
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.
Presentation: Download the presentation
Transcript: Download the transcript
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.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jon Gimbel, Executive Director, Regulatory and Quality Systems
Recorded on: June 25, 2020
Description: Clinical trial management experts Irina Petrova and Anna Yanaeva discuss reasons trial spending might exceed proposed costs and how to navigate shifting study needs while maintaining a budget. They cover:
- Determining expendable costs and expenses;
- Case studies on successful budget planning;
- Statistics on exceeding, meeting and running below budget; and
- Focusing on programmatic goals to direct spending.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Irina Petrova, Director of Clinical Operations and Anna Yanaeva, Head of Business Development, OCT Clinical
Recorded on: June 24, 2020
Description: Device regulatory expert Tina Krenc presents best practices and guidance to meet the revised risk management requirements in ISO 14971:2019. She discusses:
- How regulators and auditors will look at things differently;
- Procedural changes to make in addition to changing SOP references; and
- Rethinking the way you’ve been doing risk management.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Tina Krenc, Principal Consultant, KTA Compliance Consulting
Recorded on: June 23, 2020
Description: Pharmacovigilance expert Catherine Baldridge discusses REMS critical components as well as the importance of advanced planning and proper resource allocation to prepare you for the ultimate success of your REMS programs. She covers:
- Tools to have in place and topics to discuss when bringing on a contract research organization (CRO) partner and/or developing an in-house program;
- The recommended quality and compliance processes you need to consider during an implementation, including audit recommendations and legal considerations; and
- The importance and value of cross-functional engagement when developing and implementing a program, such as collaboration with your commercial and supply teams.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Catherine Baldridge, Owner/Founder, Essential Pharmacovigilance
