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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Webinar Training Pass
Recorded on: Oct. 31, 2016
Description: Veteran FDA consultant John Lincoln explains the revised ISO 13485’s focus on software verification and validation and outlines the FDA's preferred 11-element documentation model and how to apply it to different situations. Lincoln addresses:
- What the FDA accepts as an appropriate documentation model;
- New expectations for process and testing software; and
- When and how to use DQ, IQ, OQ, PQ or their equivalents.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: John Lincoln, Principal, J.E. Lincoln and Associates LLC
Recorded on: Oct. 26, 2016
Description: Life sciences attorney Alexander Varond provides an overview of the FDA’s Special Protocol Assessments program and the impact of new draft guidance on sponsors and regulatory affairs professionals. He discusses:
- What content to include in your SPA;
- How and when to optimally utilize SPAs to get feedback from the FDA on clinical trial design;
- Circumstances in which the FDA might rescind an SPA agreement; and
- Deadlines established by the FDA and how to avoid delays and lengthy negotiations.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Alexander Varond, Associate,Hyman, Phelps & McNamara
Recorded on: Oct. 25, 2016
Description: Cybersecurity experts Russell Jones and Nick Sikorski discuss how to conduct security risk assessments for connected medical devices and how to develop remediations to reduce risks to an acceptable level. They cover:
- What threats have emerged as medical device functionality has grown;
- The impact of the FDA’s recently released draft guidance on 510(k) submissions related to the design, development, maintenance, and disposition on connected medical devices; and
- Where the industry may be going next regarding cybersecurity of connected medical devices.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Russell L. Jones, Partner, and Nick Sikorski, Senior Consultant, Deloitte & Touche LLP, Life Sciences & Healthcare Sector – Cyber Risk Services
Recorded on: Oct. 20, 2016
Description: Quality systems expert Dan O’Leary provides and in-depth explanation of the Quality System Regulation’s requirements for purchasing controls. He discusses:
- Elements of supplier evaluation and selection;
- Maintaining supplier records to demonstrate system effectiveness; and
- The additional requirements in ISO 13485:2016.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises, LLC
Recorded on: Oct. 19, 2016
Description: Attorney Anna Laakmann explains how regulatory noncompliance can form the basis of a False Claims Act (FCA) enforcement action. She discusses:
- How to avoid FCA claims based on promotion and marketing;
- Common scenarios in which regulatory violations can give rise to FCA liability; and
- What a qui tam action is and the role that employees and other whistleblowers play in enforcing the FCA against drug and device manufacturers.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Anna Laakmann, Of Counsel, Greenberg Traurig
Recorded on: Oct. 13, 2016
Description: FDA and industry experts discuss the effect UDI implementation will have on med-tech manufacturers, healthcare providers, regulators and ultimately the patient. Topics include:
- The FDA’s intent to significantly improve device evaluation and decisionmaking through the adoption of UDI across the device ecosystem;
- Opportunities to go beyond compliance and leverage UDI for the future;
- The value of managing the device identifier (DI) and production identifier (PI) throughout the product lifecycle; and
- Effects of UDI implementation in terms of post-market quality management and future innovation efforts, including precision medicine initiatives.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Terrie Reed, FDA Senior Advisor for UDI Adoption; Daniel R. Matlis, Founder and President, Axendia; and Jean Colombel, Vice President, Life Sciences Industry, Dassault Systemes
Recorded on: Oct. 12, 2016
Description: Clinical trial management experts Jason James and Vince Postill discuss the current and emerging demands on clinical trial supply, and how to design a supply chain that is fit for future challenges. They cover:
- Developing an on-demand packaging model that meets country-specific regulatory and language labeling requirements;
- Latest packaging and labeling technologies;
- Data-driven label design and printing; and
- Language and phrase management tools.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Jason James, Senior Manager, Labeling and Innovation, Bristol-Myers Squibb and Vince Postill, Senior Vice President, Global Product & Business Development, Prisym ID
Recorded on: Oct. 5, 2016
Description: Connectivity specialist Tim Gee provides insight into the current regulatory landscape for digital devices. He covers:
- Market trends and government regulations, including the Joint Commission, FDA, and FTC guidance on mobile apps and other digital products;
- How regulatory changes impact risk management, verification testing and the use of OTS components; and
- Tactics and methods to ease the digital transformation and provide your company with a competitive advantage.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Tim Gee, Principal and Founder, Medical Connectivity Consulting
Recorded on: Sept. 29, 2016
Description: Operations management expert Dan O’Leary explains the fundamental requirements of medical device process validation and uses warning letters to illustrate best practices. He discusses:
- The role of IQ, OQ and PQ in process validation;
- Issues of parameter control, data collection and data analysis and how to apply them to production runs;
- The QSIT inspection approach and how FDA Investigators apply it; and
- New requirements introduced in the recently revised ISO 13485:2016.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises, LLC
Recorded on: Sept. 28, 2016
Description: Sparta System’s Joe Humm discusses how companies are leveraging information for benchmarking, incorporating learnings into their business processes and making better real-time decisions. Topics include:
- Company and market dynamics;
- Technology solutions; and
- Data-driven storytelling.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Joe Humm, Vice President, Global Sales Operations, Sparta System