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: Nov. 30, 2016
Description: Regulatory expert Steve Niedelman presents real-life stories he has encountered in FDA inspections and discusses how they should have been handled. He discusses how to deal with such situations as:
- A male FDA investigator who follows one of your female employees into the ladies room;
- An investigator who is verbally abusive to your employees; and
- An investigator who proposes to disassemble your roof-top HVAC unit in order to inspect it.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Steve Niedelman, Lead Quality Systems and Compliance Consultant, King & Spalding
Recorded on: Nov. 30, 2016
Description: Life sciences strategists Alan Frederickson and Crona O’Conallain share recent research showing how risk-based monitoring can increase study quality and patient safety. They discuss:
- The challenges to overcome while implementing an RBM approach;
- The technology needed to implement centralized monitoring;
- Why the distribution of data across your study sites might trigger an alarm; and
- Key metrics that can point to poor performance and noncompliance.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Alan Frederickson, Senior Director, Technology & Automation Solutions, Data Sciences, Safety & Regulatory, and Crona O'Conallain, Senior Director Data Sciences, Safety and Reporting, QuintilesIMS
Recorded on: Nov. 29, 2016
Description: Veronica Lim, William Greenrose and Nick Sikorski of Deloitte & Touche discuss how a document hierarchy is structured to capture security requirements that align with regulations and industry leading practices. They cover:
- How to integrate your Medical Device Security Program into your QMS;
- The risk of not having a consolidated document hierarchy and consistent documentation of medical device cybersecurity processes; and
- The key components to successfully implementing a medical device security document hierarchy.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Veronica Lim, Principal, Regulatory & Compliance; William Greenrose Managing Director, Advisory, Regulatory Forensics and Compliance Practice; and Nick Sikorski Senior Consultant, Advisory, Cyber Risk Services, Deloitte & Touche LLP
Recorded on: Nov. 29, 2016
Description: Recall experts Willie Bryant and Chris Harvey discuss how to assess your current recall plans to see if they’ll really work when you put them into action. They cover:
- How to decide when a recall is required;
- What resources you need to gather; and
- How to communicate with the FDA.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Willie R. Bryant, Expert Consultant, and Chris Harvey, Recall Strategist, Stericycle ExpertSOLUTIONS
Recorded on: Nov. 17, 2016
Description: Device expert Dan O’Leary demonstrates how an effective system for production equipment can improve device manufacturing, support a low-cost approach and improve equipment operator safety. He discusses:
- Quality management system requirements in QSR, ISO 13485:2003, and ISO 13485:2016;
- How to incorporate calibration requirements into production equipment maintenance
- Maintenance strategies and their application, including time-based, activity-based, and reliability-centered maintenance; and
- Classical equipment effectiveness metrics.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises
Recorded on: Nov. 9, 2016
Description: Life sciences attorney Katy Van Pelt offers advice on how to facilitate communication between the regulatory affairs and sales group. Topics include:
- Establishing a marketing review team, composed of sales and marketing, legal, and regulatory professionals that understand each other’s objectives and success standards;
- Understanding how the latest compliance mandates intersect with current social media and traditional marketing approaches; and
- Avoiding regulatory problems caused by the use of unapproved, non-compliant promotional materials by ensuring that your sales force gets the materials they need when they need them.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Katy Van Pelt, Partner, Potomac Law Group, Regulatory, Food & Drug, Healthcare, and Life Sciences Group
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