The Webinar Training Pass
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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.
The Webinar Training Pass
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.
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Webinar Training Pass
FDA and International Cannabis Regulation
90 minutes
Recorded on: Jan. 28, 2020
Description: Industrial-organizational psychologist Ginette Collazo discusses how to comply with regulations on cannabis-containing products. She covers:
- How the FDA is regulating cannabis, including how GMPs apply to the medical cannabis industry;
- How Canada and Europe are regulating cannabis, including how to comply with comparable GMP regulations from different jurisdictions; and
- Best practices for dealing with personnel requirements, process controls, procedures development, quality controls and analytical testing in cannabis production.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Ginette Collazo, Founder, Human Error Solutions
Recorded on: Jan. 23, 2020
Description: Data specialists Mary Jo Lamberti and Francis Kendall discuss the use of real-world evidence (RWE) in drug development. Topics include:
- Types of technology used to access or collect RWE;
- The key drivers for change and the adoption of RWE; and
- The potential of RWE and how it may be used across the clinical development pipeline.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Mary Jo Lamberti, Associate Director of Sponsored Research, Tufts CSDD, and Francis Kendall, Senior Director, Cytel
Recorded on: Jan. 22, 2020
Description: Computer system validation expert David Harrison shares best practices and available options for validating spreadsheets. He discusses:
- FDA examples of noncompliance and regulatory concerns with respect to 21 CFR 210-211, 21 CFR Part 11 and 21 CFR Part 820;
- How to determine spreadsheet validation gaps the FDA targets;
- How to choose an approach for efficient and repeatable validation that fits into your traditional QA and validation processes; and
- How to plan, manage and resource an effective project.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: David Harrison, Principal Consultant, CSV Compliance
Recorded on: Jan. 21, 2020
Description: Regulatory expert Grace Fu Palma provides an update on medical device regulatory reform in China. She discusses:
- New postmarket surveillance regulations and implications in adverse events and recalls reporting;
- What the regulations and requirements forecast for overseas inspections; and
- Common issues in GMP compliance.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Grace Fu Palma, CEO, China Med Device
Recorded on: Jan. 14, 2020
Description: Compliance experts Cynthia Schnedar and Liz Oestreich discuss issues surrounding data integrity. Topics include:
- Developing an organizational culture of quality that ensures data integrity;
- FDA enforcement activity; and
- Recent data integrity failures in the news.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Cynthia Schnedar, Executive Vice President, and Liz Oestreich, Vice President, Greenleaf Health
Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections
83 minutes
Recorded on: Jan. 10, 2020
Description: GxP expert David Chesney shares best practices for creating effective new SOPs for electronic document management or improving existing SOPs. He discusses:
- The legal basis of FDA records access authority;
- The types of documents commonly requested during inspections;
- The perils of emails as GxP documentation, and how to avoid them; and
- The impact of the shift to real-time electronic review of documents during inspections.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: David Chesney, Principal and General Manager, DL Chesney Consulting, LLC
FDA Adverse Event Reporting System
66 minutes
Recorded on: Dec. 18, 2019
Description: : Consultant and former FDA investigator Ricki Chase explains how to navigate the FDA’s Adverse Event Reporting System. She discusses:
- The difference between serious unexpected and serious expected events;
- Common inspection observations related to adverse events; and
- What not to report.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Ricki Chase, Executive Director, Lachman Consultant Services
Recorded on: Dec. 17, 2019
Description: A panel of quality systems experts discuss the benefits of using cloud technology solutions. They cover:
- Regulatory impact;
- Hybrid cloud approach; and
- Validating cloud solutions.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Ashley Wentworth, Director of Strategy, Vault Quality, Veeva Systems; Robert Lorence, Managing Director, PwC Consulting; Jhumki Sen, Senior Manager, PwC Consulting
Recorded on: Dec. 16, 2019
Description: Biologics development Scott Burger presents strategies for successful BLA submissions. He discusses:
- FDA requirements for cell therapy or gene therapy BLAs;
- What reviewers in the Office of Tissues and Advanced Therapies expect to see;
- How a cell or gene therapy BLA fits into the framework of the common technical document; and
- How the earlier stages in development affect the content of the BLA.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Scott Burger, Principal, Advanced Cell and Gene Therapy
Recorded on: Dec. 12, 2019
Description: Device industry veteran Jon Speer presents best practices, tips and pointers for internal company change control processes and practices. He discusses:
- The different types of change and how each should be managed;
- How to assure a risk-based approach to change management; and
- How technology solutions can help streamline change management.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jon Speer, Co-founder and Vice President of QA/RA, Greenlight Guru
