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: Feb. 20, 2020
Description: EU medical device regulatory expert James Pink describes the role of the Person Responsible for Regulatory Compliance (PRRC) under the new EU-MDR. He discusses:
- The relationship between the PRRC and the strategy set for regulatory compliance;
- Evaluating whether your corporate structure is ready to ensure supervision and control of products to achieve EU regulatory compliance; and
- The importance of organizational design to ensure the various roles participating in compliance are understood and coordinated.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: James Pink, Vice President, NSF Health Sciences Medical Devices, Europe
Recorded on: Feb. 19, 2020
Description: Quality assurance expert Susan Schniepp discusses how to streamline your audit approach so you can identify quality issues. She covers:
- How to use a risk-based approach to audits;
- Understanding the importance of quality culture and regulatory requirements identifying quality culture;
- Steps to take with the manufacturer when a quality issue is identified; and
- Best practices for documenting and tracking resolutions to identified issues.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Susan Schniepp, Independent Consultant
Recorded on: Feb. 18, 2020
Description: FDA enforcement expert Karla Palmer discusses recent trends in FDA enforcement of pharmacy compounding regulations. She covers:
- Changes brought about in draft and final guidances;
- What enforcement actions the FDA has taken against compounders to date and what could lie down the road;
- What the FDA is looking for right now; and
- The interplay between FDA and state regulation of outsourcing facilities and compounding pharmacies.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Karla Palmer, Director, Hyman Phelps & McNamara
Recorded on: Feb. 12, 2020
Description: Quality management expert Patricia Santos-Serrao discusses how connecting quality management technologies can increase efficiency. She covers:
- How to build a robust risk management protocol that automates vital actions in other systems;
- How to optimize document controls;
- Implementing a learning management system that ensures compliance; and
- Incorporating business processes into technology to automate tasks and reduce risk of critical tasks being missed.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Patricia Santos-Serrao, Director, Product Strategy, MasterControl
Recorded on: Feb. 6, 2020
Description: Quality management expert Bethany Kearney presents methods for transitioning to digital quality management methods. She discusses:
- What an enterprise cloud quality management system solution should include;
- Using quality data to move from reactive compliance to proactive performance; and
- Utilizing emerging technologies to improve decisionmaking.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Bethany Kearney, Industry Best Practices CoE, Professional Services, Sparta Systems
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