We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug News
    • Trending
    • Commercial Operations
    • GMPs
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Weekly
    • FDAnews
  • Device News
    • Trending
    • Commercial Operations
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Weekly
    • FDAnews
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
    • White Papers
  • CenterWatch
  • About Us
    • The Company
    • FDAnews Editorial Board
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
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.

LOGIN

BUY NOW Single-User 1-Year Unlimited Access $1,362

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 James DeFalco, Sales Director at jdefalco@wcgclinical.com or +1 703.538.7638 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

30 Days to A Future-Ready QMS: All While Saving Money and Staying Compliant!
59 minutes

Recorded on: Jan. 18, 2023

Description: Mickey Landkof, general manager and global vice president of sales for Dot Compliance, shares how to choose the right QMS software system for your company and use industry best practices to get it up and running in 30 days. He clarifies:

  • Why it takes so long for traditional QMS solutions to go live;
  • The steps required for a 30-day QMS implementation;
  • How to save time, money and resources, and decrease time to market by doing away with fully customized QMS solutions; and
  • How to build a future-ready strategy.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Mickey Landkof, General Manager and Global Vice President of Sales, Dot Compliance

FDA Pathways to Bring your Medical Device to Market: What Regulatory Professionals Need to Know
75 minutes

Recorded on: Jan. 17, 2023

Description: Shelly Garg, president and founder of the FDA regulatory compliance law firm Garg Law, explains the device marketing requirements and the various benefits, challenges and drawbacks associated with different regulatory pathways. She shares:

  • How a device is classified by the FDA;
  • How to determine whether your company’s product is a medical device and how the FDA intends to classify and regulate it;
  • Features, benefits, challenges and drawbacks of device marketing pathways, including premarket notification (510(k)), Premarket Approval (PMA), De Novo, Humanitarian Device Exemption (HDE) and Custom Device Exemption (CDE); and
  • Best practices and what the FDA is looking for in each pathway approach.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Shelly Garg, President and Founder, Garg Law

Beginning with the End in Mind: Inspection Readiness — A Sponsor’s Perspective
52 minutes

Recorded on: Dec. 15, 2022

Description: Donna Dorozinsky shares a strategy for identifying key parts that represent your study’s unique inspection risks, what you can do now to become more inspection prepared and the key processes you can put into place at study start-up so you’re continually inspection-prepared. You’ll learn:

  • How to identify key study activities where inspection risk may exist;
  • An approach that allows you to understand your study’s story even if you were not a participant in the management of the study;
  • How to identify key processes to put in place at study start-up to ensure that inspection preparation is integral to routine business; and
  • Ideas for better inspection preparation.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Donna Dorozinsky, President and CEO, Just in Time GCP

Gene & Cell Therapy Regulation: Comparability and Other New Developments
90 minutes

Recorded on: Dec. 14, 2022

Description: This webinar enables you to understand and comply with the FDA’s requirements and avoid common errors, so you can maintain your products’ critical quality attributes (CQAs) and bring them to market. You’ll learn:

  • FDA requirements for comparability studies for gene and cell therapy products;
  • Best practices for risk analysis and mitigation using comparability studies;
  • How to design an effective comparability protocol for a gene or cell therapy product;
  • How to construct a statistical approach to comparability; and
  • How to assemble the comparability package to comply with FDA requirements.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Scott R. Burger, MD, Principal, Advanced Cell & Gene Therapy; and William E. Janssen, PhD, Principal, WEJ Cell and Gene Therapy Consulting Services

Building a World-Class Regulatory Intelligence and Support System: What Regulatory, Compliance and Quality Professionals Need to Know
63 minutes

Recorded on: Dec. 13, 2022

Description: Dennett Kouri and Faviola Michelot detail how to build a regulatory intelligence management system that will enable you to stay ahead of the changes and stay compliant, sharing:

  • What regulatory intelligence is and how you can develop and implement it;
  • What resources are needed to support regulatory intelligence;
  • The new regulatory trends you must have on your radar; and
  • How to pursue engaging opportunities with regulators.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Dennett Kouri, Senior Vice President, Edwards Lifesciences; and Faviola Michelot, Senior Director, Edwards Lifesciences

Engaging with the FDA: Best Practices for Dealing with Warning Letters, Seizures, Injunctions — and More
68 minutes

Recorded on: Dec. 1, 2022

Description: Steve Silverman, president of The Silverman Group — and previous director of the Center for Devices and Radiological Health’s (CDRH) Office of Compliance and assistant director of the Center for Drug Evaluation and Research’s (CDER) Office of Compliance — shares how to engage effectively with the FDA. He’ll cover:

  • What effective FDA regulatory engagement means as well as misperceptions to be aware of;
  • The four essential principles of effective regulatory engagement: informed, trust-based, timely, appropriate;
  • The three steps to achieve effective regulatory engagement; and
  • How novel issues like digital technology and real-world evidence influence effective regulatory engagement.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Steve Silverman, President, The Silverman Group

The Unification Impact: The Unique Benefits of One System that Replaces Many
50 minutes

Recorded on: Nov. 30, 2022

Description: Take control of compliance and data integrity to accelerate research and development from drug discovery to clinical processes through a unified compliance management solution. Learn how to:

  • Unify and connect disparate systems and processes together within your quality and compliance system to mitigate risks and increase efficiencies; and
  • Integrate total compliance, quality, and risk management system that will not only replace 10–12-point solutions into one unified solution but also provides a collaborative environment that saves time and speeds up product launches.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Anu Ganguly, Senior Director, Strategic Client Partner, Xybion; and James Castonguay, Assistant Vice President, Product Development, Xybion

Writing CAPAs the Right Way
35 minutes

Recorded on: Nov. 29, 2022

Description: Effective CAPA implementation needs effective problem communication with team members, clear description of actions and clear goals. Learn how to:

  • Communicate corrective actions in a manner to ensure compliance;
  • Outline typical CAPA writing problems; and
  • Steps to follow to structure effective CAPA’s.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Judith Meritz, Life Sciences Regulatory Consultant, Meritz & Muenz LLP

MDUFA Reauthorization Developments: What Regulatory, Compliance and Quality Professionals Need to Know
54 minutes

Recorded on: Nov. 10, 2022

Description: Jessica Ringel sheds light on the changes in user fees, the commitments the FDA’s Center for Devices and Radiological Health (CDRH) has made to the device industry in connection with its performance on marketing applications and related premarket processes — and what that could mean for you — and she’ll discuss what comes next for the unenacted legislation, including:

  • How to budget for future marketing applications by understanding the increases in user fees being assessed for device applications;
  • CDRH’s timeline commitments so you can better anticipate its marketing application review and the potential effects on timing of new device market launches; and
  • When to expect certain guidance documents the FDA has promised to issue over the next few years as part of its MDUFA V commitments, including revisions to the guidance documents on real-world evidence and presubmissions.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Jessica Ringel, Partner, King & Spalding

Charging for Investigational Drugs and Devices: What You Must Know About Opportunities and Pitfalls in Recovering Direct Costs
56 minutes

Recorded on: Nov. 9, 2022

Description: Of counsel Paul Gadiock, who was a former associate center director for policy at the FDA’s Center for Devices and Radiological Health, and associate Olivia Cusimano — both with Wilson Sonsini Goodrich & Rosati — clarify the FDA’s current stance on charging for investigational drugs and devices. And they share:

  • The factors to consider when deciding whether to seek cost recovery from participants in different clinical trial phases, such as retaining runway revenue and maintaining adequate recruitment;
  • Which investigational drug expenses can be recovered without FDA authorization, which can only be recovered with FDA authorization and which cannot be recovered at all; and
  • The documentation requirements for sponsors to receive FDA authorization for cost recovery under the agency’s most recent guidance, Charging for Investigational Drugs Under an IND: Questions and Answers.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Paul Gadiock, Of Counsel, Wilson Sonsini Goodrich & Rosati; and Olivia Cusimano, Associate, Wilson Sonsini Goodrich & Rosati

Previous 1 2 3 4 5 6 7 8 9 … 78 79 Next

Upcoming Events

  • 28Sep

    The Cost of Counterfeiting: Why You Need a Plan to Secure Your Medical Device Supply Chain

  • 28Sep

    Calculating Sample Size to Satisfy FDA Expectations

  • 11Oct

    GMP Quality Management vSummit 2023: Where Quality Meets Risk

  • 16Oct

    MAGI@home Clinical Research Conference 2023

  • 26Oct

    FDA in 2024: What to Expect in an Election Year

  • 02Nov

    How UDI and UDI Data Can — and Must — Be Used for More Than Just Device Identification

Featured Products

  • FDA, FTC and DOJ Enforcement of Medical Device Regulations

    FDA, FTC and DOJ Enforcement of Medical Device Regulations

  • Using Real-World Evidence in Drug and Device Submissions

    Using Real-World Evidence in Drug and Device Submissions

Featured Stories

  • Expert Says FDA Under No Obligation to Educate Companies on Inspection Rights

  • FDA Deems Hamilton Ventilator Recall Class I for Software Issue Causing Device to Stop

  • Survey Shows Nearly All Pharm Techs Face Drug Shortages, Pfizer Plant Shortages Continue Until 2024

  • FDA Shares Premarket Requirements for Device Cybersecurity in Final Guidance

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell or Share My Data
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing