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.
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Webinar Training Pass
Recorded on: March 18, 2021
Description: Cynthia Schnedar ensures that you understand how the FDA conducts its postmarket safety surveillance and what you must do to ensure postmarket adverse reporting inspection readiness. She explains:
- The FDA Adverse Event Reporting System (FAERS) and how the FDA evaluates the information in the database;
- Nuances of the FDA Program Guide CHAPTER 53 - Postmarketing Surveillance and Epidemiology: Human Drug and Therapeutic Biological Products Program: 7353.001;
- How the FDA uses its MedWatch program to provide information on mandatory reporting by manufacturers; and
- What type of reports a manufacturer must submit to the FDA when deviation from current good manufacturing practice regulations occur.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Cynthia Schnedar, Executive Vice President of Regulatory Compliance, Greenleaf Health
Recorded on: March 18, 2021
Description: Sundeep Agarwal addresses manufacturers’ challenges in designing a compliant AI framework that is safe, effective and beneficial for human health around the world, including:
- Introduction to artificial intelligence (AI);
- Overview of the regulatory framework of AI in the U.S. and EU;
- AI-based software classification; and
- Quality system and good machine learning practices (GMLP).
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Sundeep Agarwal, General Manager of Compliance & Regulatory Affairs, Datt Mediproducts, India
Recorded on: March 16, 2021
Description: Susan M. Proulx, PharmD, Managing Director, Drug Safety at Leaderboard Branding is an international leader in preventing medication errors due to brand name confusion. She shares:
- How the prescreening process relates to attributes that may contribute to medication errors in naming drugs;
- Suggested methods of evaluating the risk of medication errors related to naming;
- The FDA process for notifying applicants that have similar names in the FDA queue; and
- The phonetic and orthographic computer analysis (POCA) criteria and its use in evaluating name similarity.
Presentation: Download the presentation
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Speaker: Susan Proulx, Managing Director of Drug Safety, Leaderboard Branding
Recorded on: March 10, 2021
Description: The FDA restarted inspections last summer under a new guidance and during this webinar FDA inspections expert Kalah Auchincloss shares how assessments are proceeding and what criteria the FDA is using to determine which sites are inspected.
- FDA criteria for in-person inspections;
- Alternatives to on-site inspections;
- Preparation for FDA inspections; and
- The likelihood of foreign inspections resuming.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Kalah Auchincloss, Senior Vice President and Deputy General Counsel, Greenleaf Health, Inc.
Recorded on: Feb. 18, 2021
Description: A panel of experts discusses how to modernize and digitally transform your manufacturing operations to support quality metrics, review by exception and smartsourcing. They share:
- Training as a strategic function;
- The differences between content standards and integration standards;
- Elearning standards and why they are important; and
- Choosing the right vendors.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kent Malmros, Sr. Director of Vault Training, Veeva Systems; Lexie Pieper, Head of Quality, Celularity; John Constantine, Consultant, Orchestrall; Amy Benton, Vice President of Information Technology, Travere Technologies
Recorded on: Feb. 17, 2021
Description: A panel of experts explains how to prepare, organize and streamline manufacturing auditing processes using a risk-based approach. They’ll discuss:
- How to use a risk-based approach to audits;
- 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.
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Speakers: Susan Schniepp, Distinguished Fellow, Regulatory Compliance Associates® Inc.; Seyed Khorashah, Vice President of Medical Device and CTO, Regulatory Compliance Associates® Inc.; Steven J. Lynn, Executive VP, Pharmaceuticals, Regulatory Compliance Associates® Inc.
Recorded on: Feb. 11, 2021
Description: Pradip Banerjee and Dhanasbri Gudi, discuss how to leverage compliance, quality and digital lab information systems from the cloud. They’ll cover how to:
- Enable tracking and tracing from collection site to healthcare providers and regulatory bodies;
- Create a new paradigm for the post-COVID-19 world of holistic digital quality and compliance management;
- Always be ready for e-Audit, e-Sourcing and e-Inspections; and
- Bring results to market at rapid speeds with full regulatory compliance in the digital workplace.
Presentation: Download the presentation
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Speakers: Dr. Pradip Banerjee, Chairman of the Board and Chief Executive Officer, Xybion; Dr. Dhanasbri Gudi, Laboratory Management Specialist, Xybion
Recorded on: Feb. 10, 2021
Description: A panel of FDA experts share the changes they expect to see from the agency’s administrative shift. They’ll cover:
- What changes are expected at the FDA with the new administration;
- Policies and programs organizations should consider implementing;
- Day-to-day adjustments that could help your team navigate the changes; and
- Insights into shifts around drug and device regulation, enforcement, drug pricing and healthcare innovation.
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Speakers: Wayne Pines, Member, APCO Worldwide’s International Advisory Council and President of Health Care; Marc Scheineson, Partner, Alston & Bird LLP; Esther Krofah, Executive Director, FasterCures; Lowell Schiller, Chief Legal and Regulatory Officer, Aetion
Recorded on: Jan. 27, 2021
Description: FDA submissions expert Judity Meritz outlines the key information needed for an FDA emergency use authorization (EUA) application for a medical device. She discusses:
- The scope of an EUA;
- What the FDA looks for in the crucial risk-benefit section;
- How the EUA’s criteria for safety, performance and labeling differ from the FDA’s regular medical device clearance and approval process; and
- The FDA’s thought process — and concerns raised — in recent EUA submissions.
Presentation: Download the presentation
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Speaker: Judith Meritz, Partner, Meritz & Muenz
Recorded on: Jan. 27, 2021
Description: China regulatory expert Grace Fu Palma discusses the China National Medical Products Administrations developing clinical trial regulations. She covers:
- Different clinical pathways and how to decide which pathway to choose;
- Key areas you need to pay focus on to shorten clinical trials and approval times;
- Whether your devices qualify for the real-world data/study Hainan program and how to get into the program; and
- Key considerations on the feasibility and justification of overseas clinical data acceptance.
Presentation: Download the presentation
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Speaker: Grace Fu Palma, CEO, China Med Device