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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.
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
Recorded on: Oct. 16, 2015
Description: Industry expert Andrew Harrison provides an overview of the draft guidance and the specific quality metrics requested. He discusses:
- How the FDA intends to use the quality metrics data;
- Who is required to comply;
- What data the FDA is proposing to be reported; and
- When the metrics/data should be reported.
Presentation: Download the presentation
Speaker: Andrew Harrison, Chief Regulatory Affairs Officer & General Counsel, Regulatory Compliance Associates, Inc.
Device Complaint Management
92 minutes
Recorded on: Oct. 13, 2015
Description: Quality operations expert Dan O'Leary discusses how to develop a complaint management system that will pass FDA muster. Topics include:
- The difference between complaint evaluation and complaint investigation;
- The conditions that require an investigation and the associated records;
- Determining reportability as an MDR;
- Linking individual complaints to the risk management file;
- Complaint analysis to determine quality problems; and
- Linking complaint analysis results to the risk management file.
Presentation: Download the presentation
Speaker: Dan O'Leary, President, Ombu Enterprises, LLC
Recorded on: Sept. 30, 2015
Description: Alberto Grignolo, a specialist in the Japanese pharmaceutical market, explains the unique steps, priorities and expectations involved in dealing with Japanese regulators. Topics include:
- Reasons for the drug development lag between the U.S. and Japan;
- Roadmap for product development in Japan; and
- Japan's "Strategy of Sakigake" and how it aims to speed product development.
Presentation: Download the presentation
Speaker: Alberto Grignolo, Corporate Vice President, PAREXEL
The Biopharmaceutical Facility of the Future
74 minutes
Recorded on: Sept. 29, 2015
Description: Biotechnology experts Herman and Erich Bozenhardt explore commercial factors driving the industry, define future process requirements and provide a view of how change is accelerating from evolution to revolution. Topics include:
- The process technologies driving the future of the business;
- A glimpse of the minimalist, modular state that companies will evolve towards; and
- The future of compliance — a singular "bullet-proof" concept without contamination.
Presentation: Download the presentation
Speakers: Herman Bozenhardt, President, Bozenhardt Consulting Services LLC, and Erich Bozenhardt, Process Group Lead, Integrated Project Services, Inc.
Recorded on: Sept. 25, 2015
Description: Medical device engineering and compliance expert Roberta Goode explains how to avoid obstacles between your products and the European market. Topics include:
- The difference between horizontal and vertical standards;
- Which of those standards apply to each of your devices, and the last time they were updated;
- The specific kinds of objective evidence auditors will expect to see; and
- Factors that could lead to more frequent audits?
Presentation: Download the presentation
Speaker: Roberta Goode, President and CEO, Goode Compliance International
Negotiating an FDA Import Hold Crisis
74 minutes
Recorded on: Sept. 22, 2015
Description: Consultant and former FDA regulatory counsel describes the FDA's expectations and qualifications and U.S. Customs' operational processes. He covers:
- What to do to minimize risk of delays, detentions and refusals;
- How to work closely with suppliers, contract manufacturers and labelers to significantly reduce hold times; and
- How to conduct a gap analysis to identify weaknesses in your existing compliance program.
Presentation: Download the presentation
Speaker: Ben England, CEO, FDAImports.com
Recorded on: Sept. 15, 2015
Description: Health information specialist Susan Brink discusses FDA and NIH guidances on e-consent and explains the major benefits of employing e-consent software. She covers:
- Deciding which software is right for your company;
- How much training will be needed for your staff to understand and use the new software properly;
- Whether electronic media can help keep patients better informed; and
- How much is too much — or too little — to spend on an e-consent system.
Presentation: Download the presentation
Speaker: Susan G. Brink, Executive Vice President, e-consent Products and Services, Enforme Interactive, Inc.
The Debate on Off-Label Promotion
91 minutes
Recorded on: Aug. 31, 2015
Description: Two noted experts join FDAnews for a presidential-style debate on the FDA's interpretation of rules on off-label promotion.
Speakers: Ralph F. Hall, Counsel, Faegre Baker Daniels LLP, Professor of Practice, University of Minnesota Law School, and Timothy Mackey, Director, Global Health Policy Institute, Assistant Professor of Anesthesiology and Global Public Health, University of California San Diego School of Medicine
Recorded on: Aug. 25, 2015
Description: Consultant Herman Bozenhardt explains how to use validation tools to create risk-based assessments that will help increase compliance, minimize the spiraling costs of validation and reduce project delivery time. He discusses:
- How ASTM E2500 and ICH Q9 were developed and why they're superior;
- Rapid and cost-effective deployment of these modern standards;
- Why "qualification" is a more accurate term than validation; and
- How to rebuild a project model around new methodology.
Presentation: Download the presentation
Speaker: Herman Bozenhardt, President, Bozenhardt Consulting Services, LLC
Combination Product GMP Compliance
92 minutes
Recorded on: Aug. 19, 2015
Description: Noted combination products expert Mary C. Getz guides manufacturers through the options that a company can take in developing a compliance strategy. Topics include:
- Understanding the FDA's guidance on the various compliance approaches;
- Key inputs to developing a compliance strategy;
- Whether manufacturers need to update supplier agreements or SOPs in light of the guidance; and
- How combination product makers should work with the FDA.
Presentation: Download the presentation
Speaker: Mary C. Getz, Vice President of Quality Systems, Medical Devices Consulting, NSF Health Science