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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
Off-Label Drug Promotion
52 minutes
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
Medical Device Supplier Quality Management
74 minutes
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
Corrections and Removals Guidance
91 minutes
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.
Presentation: Download the presentation
Transcript: Download the transcript
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
Transcript: Download the transcript
Speaker: Armin Torres, Principal/Senior Software Consultant, Qualified Data Systems
New Trump Administration, New Republican Congress: What Will the FDA’s Agenda Be in 2017?
74 minutes
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.
Presentation: Download the presentation
Transcript: Download the transcript
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
Transcript: Download the transcript
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.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises, LLC
Ensure Raw Material Quality and Finished Product Authenticity Throughout the Supply Chain
59 minutes
Recorded on: Dec. 8, 2016
Description: Industry expert Robert Brooks discusses the challenges and implications of dealing with a global supply chain and the immediate need for drug makers to become more proactive. Topics include:
- Understanding the views and requirements of worldwide regulatory bodies regarding end-to-end supply chain management;
- Goals and deadlines of FDA, EMA and ICH regulations and guidances that will impact the management of raw materials and finished products;
- Proven strategies for effective risk management ; and
- Current best practices to build and maintain your supply chain.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Robert Brooks, CEO, Blewbury Brooks Consulting Limited
Centralized Submissions Management
54 minutes
Recorded on: Dec. 1, 2016
Description: Process automation expert Jack Yeager discusses software solutions that streamline and automate your core business processes saving millions of dollars through improved compliance, reduced employee workload and lower operating costs. He covers:
- Leveraging technology to help ensure submissions are completed on time, with minimal resource impact;
- Simplifying the submission process;
- Improving communications;
- Anticipating resource issues; and
- Visualizing processes and issues.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jack Yeager, Founder, Sylogent