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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.
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 Russ Titsch, Business Development Director at russ.titsch@wcgclinical.com or +1 703.538.7651 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.
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Webinar Training Pass
Remote Monitoring of Clinical Trial Sites
94 minutes
Description: Hoffman LaRoche/Genentech veteran Ken Schiff demonstrates how to use quality risk management principles, electronic data capture and other IT systems to monitor clinical trial sites remotely. Topics include:
- Automatic analysis of existing data that allows continuous risk management;
- Calculating risk priority; and
- Key steps for QRM implementation.
Presentation: Download the presentation
Speaker: Ken Schiff, President and Owner, Quality Risk Management Associates, LLC
Is It a Cosmetic, a Drug, or Both?
80 minutes
Description: Consultant Kim Egan explains how the FDA regulates cosmetics and what the agency considers a drug. Topics include:
- GMP requirements;
- Banned and restricted substances; and
- Cosmetics labeling rules.
Presentation: Download the presentation
Speaker: Kim Egan, Principal, Saltbox Consulting
New OTC Labeling Guidances
61 minutes
Description: Attorney Kari Sutherland details important features of an OTC product that FDA guidance recommends should prompt a self-selection study. Sutherland also covers:
- Self-selection study design, objectives and conduct;
- How to conduct label comprehension studies; and
- When to conduct actual use studies.
Presentation: Download the presentation
Speaker: Kari Sutherland, Attorney, Butler, Snow, O’Mara, Stevens & Cannada, PLLC
Description: Industry expert Barbara Immel examines issues with parenteral products in FDA inspections and how to avoid warning letters. Topics include:
- Recent compliance cases;
- FDA inspection ratings; and
- How the FDA conducts drug and biologics inspections.
Presentation: Download the presentation
Speaker: Barbara Immel, President, Immel Resources LLC
Description: Pharmatek’s Bryan Knox explains his company’s strategy for making sure the chemistry and manufacturing section of a drug application will pass FDA muster. Knox outlines a “scorecard” model that assesses:
- API stability and potency;
- Formulation and dosage strength;
- Level of CMC expertise required.
Presentation: Download the presentation
Speaker: Bryan Knox, Senior Director of Pharmaceutics, Pharmatek
Physician Payment Disclosure to CMS
95 minutes
Description: A team of regulatory experts outlines the requirements of the Physician Payment Sunshine Act and the reporting timeline. Topics include:
- Common issues and gaps in reporting;
- Managing physician relationships; and
- Designing an inquiry and dispute resolution system.
Presentation: Download the presentation
Speakers: Tim Robinson, Esq., Executive Vice President and General Counsel, MMIS, Inc. and Seth Lundy, Esq., Partner, King & Spalding
Device History Records
102 minutes
Description: Medical device compliance expert Dan O’Leary shares his device history record (DHR) management plan that follows the requirements of the Quality System Regulations. O’Leary covers:
- Standard flow of information from design input to servicing;
- Types of device-specific records;
- Exceptions for Class I devices; and
- Unique device identification.
Presentation: Download the presentation
Speaker: Dan O’Leary, President, Ombu Enterprises LLC
Auditing Virtual Suppliers
84 minutes
Description: Supplier management pro John Avellanet explains how to audit suppliers that have no physical site to visit. Avellanet covers:
- Definitions of “virtual manufacturer,” “virtual company,” and “virtual enterprise;”
- How to tell if a supplier is a virtual operation;
- What records to keep to prove to FDA inspectors that you have audited suppliers; and
- Items to request from a supplier being audited.
Presentation: Download the presentation
Speaker: John Avellanet, Managing Director, Cerulean Associates LLC
Description: Quality risk management expert Ken Schiff examines quality risk management and how it applies to clinical development. Topics include:
- Using quality risk management to assess data more frequently and effectively;
- Protocol quality by design; and
- Risk assessment questionnaires and reporting models.
Presentation: Download the presentation
Speaker: Ken Schiff, President, Quality Risk Management Associates, LLC
Sec. 820.80: Acceptance Activities
99 minutes
Description: Industry expert Dan O’Leary analyzes FDA warning letters to demonstrate how understanding the agency’s enforcement emphasis can help inform a robust acceptance program. O’Leary provides insight on:
- Definition of key terms;
- How to understand and leverage sampling plans; and
- How to adequately respond to an FDA warning letter.
Presentation: Download the presentation
Handout: Download Checklist for acceptance activities
Speaker: Dan O’Leary, President, Ombu Enterprises LLC