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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.
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.
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
Reporting Failed Clinical Trial Data
96 minutes
Description: Attorney Scott Cunningham helps regulatory affairs and clinical trial management teams to prepare for upcoming changes in clinical trial data reporting. Topics include:
- Assuring that entries in ClinicalTrials.gov are consistent with internal records and addressing gaps in reporting;
- Determining when the 21-day rule begins;
- The ramifications of submitting trials on off-label drugs; and
- How much data is expected for adverse events.
Presentation: Download the presentation
Speaker: Scott Cunningham, Partner, Covington and Burling, LLP
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Description: Regulatory affairs expert Mukesh Kumar teaches how to structure a risk-based raw materials management program suited for the GMP environment. Topics include:
- FDA's expectations regarding raw material vendor selection;
- Proven and cost effective measures for assuring acceptable quality of materials;
- Sampling and assurance documentation quality control units expect; and
- Training requirements for frontline employees and managers.
Presentation: Download the presentation
Speaker: Mukesh Kumar, Regulatory Affairs and Quality Assurance, Amarex
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Selecting and Managing Device Suppliers
70 minutes
Description: Supplier management expert Jeff Kasoff offers proven techniques for complying with FDA QSR and ISO 13485 supplier management requirements. He covers:
- The latest interpretation of QSR and ISO 13485 requirements for supplier selection and assessment — and how US and EU investigators are applying it during inspections;
- How to on-board and qualify new suppliers in a cost-efficient manner; and
- Innovative assessment techniques for current suppliers.
Presentation: Download the presentation
Speaker: Jeff Kasoff, Director of Quality, Medivators
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Description: Drug and device expert Lynn C. Tyler explains the potential impact of the FDA's final guidance, "Circumstances that Constitute Delaying, Denying, Limiting, or Refusing to Permit Drug Inspection." He provides:
- Legal and operational strategies for responding to FDA's assertion of increased authority; and
- Best practices for coordinating between the investigator, regional office and FDA headquarters if disagreements arise in the conduct of an inspection.
Presentation: Download the presentation
Speaker: Lynn C. Tyler, Partner, Barnes and Thornburg, Food, Drug and Device Law Practice Group
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Description: Regulatory expert Michael Swit uses FDAnews' exclusive FDA Form 483 database to demonstrate how analyzing these documents can help you prepare for your next inspection. He discusses:
- What can be learned from examining 483s;
- How to respond to a 483; and
- FDA expectations.
Presentation: Download the presentation
Speaker: Michael Swit, Special Counsel, Duane Morris LLP
Description: Consultant John E. Lincoln teaches how to keep your audit program on track and effective. He explains how to:
- Enhance organizational awareness of internal audit requirements;
- Best conduct the audits; and
- Properly document and present the results during inspections.
Presentation: Download the presentation
Speaker: John E. Lincoln, Principal, J.E. Lincoln and Associates, LLC
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Device De Novo Reclassification
77 minutes
Description: Attorneys Jonathan Kahan, Kristin Zielinski and Kelliann Payne explain in detail the FDA's new one-step de novo reclassification procedure and how to assure that your petition includes all the required data elements and supporting research the FDA has requested. They cover:
- FDA's evolving view of substantial equivalence and de novo reclassification;
- When a de novo reclassification petition is appropriate; and
- When and how to use the pre-submission process.
Presentation: Download the presentation
Speakers: Jonathan Kahan, Partner and Co-director, Food, Drug, Medical Device and Agriculture Group, Hogan Lovells; Kristin Zielinski, Director of Regulatory Sciences, Hogan Lovells; and Kelliann Payne, Counsel, Hogan Lovells.
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Preparing for an FDA Inspection
94 minutes
Description: Award-winning compliance expert John Avellanet presents a 16-step approach for inspection preparation. Topics include:
- How an FDA investigator prepares for an inspection;
- Workflow of the inspection - from the FDA's perspective; and
- Seven steps to immediately take upon receiving FDA notification of an inspection.
Presentation: Download the presentation
Speaker: John Avellanet, Founder, Cerulean Associates, LLC
Description: Attorney Lee Rosebush and Nita Garg discuss the impact of the 2014 "Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations." They cover:
- The 3 most important aspects of the Purple Book for healthcare providers and manufacturers;
- Tips and strategies of for maximizing reimbursement by using the Purple Book; and
- Steps to ensure correct use of the Purple Book.
Presentation: Download the presentation
Speakers: Lee Rosebush, counsel, and Nita Garg, associate, Baker & Hostetler LLP
Drug Promotion Enforcement Letters
89 minutes
Description: Attorney Julie Tibbets uses actual FDA enforcement letters to show what the agency is looking for in branding, advertising and promotion. Topics include:
- Current enforcement letter trends;
- 19 buzzwords that appear most often in OPDP enforcement letters; and
- Ten best practices that lower the risk of receiving an OPDP letter.
Presentation: Download the presentation
Speaker: Julie Tibbets, Partner, Food, Drug & Device/FDA Group, Alston & Bird LLP