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Home » Webinars

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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Also available: Take advantage of our multi-user and site licenses of the Webinar Training Pass, so you’ll have the most-informed workforce! Contact Will Tuttle, Business Development Representative at wtuttle@fdanews.com or +1 612.216.2948 to receive a custom quote.

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

Pharmaceutical Postmarket Surveillance: Latest Developments in the Era of COVID-19
47 minutes

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

Artificial Intelligence and Machine Learning in Medical Technology: Fundamentals and Emerging Regulation
61 minutes

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

Pharmaceutical Naming Regulation: Understanding the Latest Developments
58 minutes

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

Transcript: Download the transcript

Speaker: Susan Proulx, Managing Director of Drug Safety, Leaderboard Branding

FDA Drug GMP Facility Inspections During the Pandemic
90 minutes

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.

Bring Your Own Content (BYOC): An Optimized Approach to Streamlining Life Sciences Training
60 minutes

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

Effective Auditing for Manufacturing Quality
90 minutes

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.

Presentation: Download the presentation

Transcript: Download the transcript

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.

Lab X.0: Addressing Quality and Compliance Challenges in Laboratory Operations in the COVID-19 All-Digital Era
49 minutes

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

Transcript: Download the transcript

Speakers: Dr. Pradip Banerjee, Chairman of the Board and Chief Executive Officer, Xybion; Dr. Dhanasbri Gudi, Laboratory Management Specialist, Xybion

FDA Under the Biden Administration: What’s to Come and What Will It Mean
93 minutes

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.

Presentation: Download the presentation

Transcript: Download the transcript

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

FDA’s Response to COVID-19: Fundamentals of Obtaining Emergency Use Authorization
51 minutes

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

Transcript: Download the transcript

Speaker: Judith Meritz, Partner, Meritz & Muenz

Medical Device Clinical Trials in China: Latest Regulatory Developments
84 minutes

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

Transcript: Download the transcript

Speaker: Grace Fu Palma, CEO, China Med Device

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