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.
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Webinar Training Pass
Recorded on: Feb. 1, 2017
Description: Food and drug law expert Jim O’Reilly explains new mandates set by the 21st Century Cures Act and how they will change medical device regulations in several key areas, including data development, clinical approvals, breakthrough devices, inspections and humanitarian device exemptions. He discusses:
- How Congress has thrown a curve at the FDA’s stringent review process, enabling far easier approval for lower-risk devices;
- How the FDA intends to implement the new acceptance program for foreign medical device research; and
- What effect the act’s emphasis on “less burdensome” regulations will have on the industry.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jim O’Reilly, Professor of Law (Retired), University of Cincinnati College of Law
Recorded on: Jan. 31, 2017
Description: Medical device expert Grace Fu Palma discusses recent developments in Chinese manufacturing regulations, including new GMPs, self-inspections, foreign inspections and trends in enforcement. She covers:
- Implementation of the new GMPs, including the procedural rules for inspections;
- Transfer of manufacturing sites and amendment of manufacturing and device licenses;
- Policies and rules on contract manufacturing for medical devices; and
- Handling self-inspections and evaluations of past compliance, including recent examples.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Grace Fu Palma, CEO, China Med Device, LLC
Recorded on: Jan. 30, 2017
Description: Regulatory attorney Alan Minsk discusses the FDA’s latest rules on what speech is and is not protected. He covers:
- FDA’s enforcement against pre-approval promotion;
- The PhRMA/BIO principles on sharing truthful and non-misleading information;
- FDA's recent public hearing on off-label communications; and
- Non-FDA-related issues to consider with off-label promotion.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Alan G. Minsk, Partner and Leader of the Food and Drug Practice Team, Arnall Golden Gregory
Recorded on: Jan. 27, 2017
Description: Quality assurance expert James Shore provides up-to-date information on purchasing controls for quality assurance and control of purchased components, services or finished medical devices. He covers:
- Performing a gap assessment to the new ISO requirements and QSR expectations;
- Reviewing supplier quality agreements for key elements; and
- Performing and documenting risk assessment of suppliers.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: James Shore, Director of Quality Assurance/Regulatory Affairs, Titan Medical, Inc.
Recorded on: Jan. 25, 2017
Description: Regulatory law expert Darshan Kulkarni explains the FDA’s three draft guidances on compounding. He discusses:
- The latest areas of FDA enforcement in compounding;
- Requirements for 503A (traditional compounders) and 503B (outsourcing facilities);
- How to establish a core FDA inspection team; and
- How to create an appropriate FDA response to a Form 483.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Darshan Kulkarni, Principal Attorney, Kulkarni Law Firm
Recorded on: Jan. 19, 2017
Description: Medical device regulatory expert Dan O’Leary explains the nuances of the FDA’s requirements for corrections and removals. He covers:
- The difference between corrections and removals;
- The difference between Part 7 and Part 806 recall rules;
- How to determine if you need to report to the FDA; and
- How the new cybersecurity guidance applies to corrections and removals.
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Speaker: Dan O’Leary, Ombu Enterprises LLC
Recorded on: Dec. 19, 2016
Description: Quality assurance expert Armin Torres discusses how to make sure that your data — which has come from multiple sources — is internally consistent across the full data set and with your company metrics and KPIs. Topics include:
- How to make raw data available using the least burdensome approach;
- How to control the cost of manual or automated data collection, review, and aggregation;
- How to develop a process for digital data extraction, cleansing, integration, and validation prior to reporting; and
- How to make available training and resources for data analysis, interpretation, and visualization.
Presentation: Download the presentation
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Speaker: Armin Torres, Principal/Senior Software Consultant, Qualified Data Systems
Recorded on: Dec. 15, 2016
Description: Regulatory expert Steven Grossman discusses the FDA’s activities under the Obama administration and what it likely will be doing under the next administration. Topics include:
- The likelihood that the current commissioner will continue to head the agency —for how long — and who the top candidates are to replace him;
- What the FDA’s likely priorities will be in 2017 under the new administration; and
- How the new Congress is likely to impact what FDA does in 2017.
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Speaker: Steven Grossman, President, HPS Group, LLC
Recorded on: Dec. 14, 2016
Description: Global drug safety expert Graeme Ladds teaches how to develop and maintain Company Core Data Sheets. Topics include:
- Differences between Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI);
- EU vs. U.S. interpretation of what to include in a CCSI; and
- How and when to add to a CCSI.
Presentation: Download the presentation
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Speaker: Graeme Ladds, CEO, PharSafer Associates Ltd.
Recorded on: Dec. 14, 2016
Description: Systems expert Dan O’Leary explains the FDA’s QSR requirements for validation of software used in both production and the quality management system. He discusses:
- How and why the FDA is focused on this emerging threat area;
- The systems that need validation and revalidation; and
- Why software validation and revalidation needs to be proportionate to the risk associated with the use of the software.
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Speaker: Dan O’Leary, President, Ombu Enterprises, LLC