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Home » Webinars

Now get all the training you need – all in one place, and all for one low price!

The FDAnews Webinar Training Pass program gives you year-round unrestricted access to any of the hundreds of webinars listed below. These training programs feature top consultants, expert speakers and FDA officials.

PLUS, subscribers get automatic access to all our new training programs for the next 12 months – that’s more than 50 new programs a year!

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.

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Webinar Training Pass

Managing Your Pharmaceutical Suppliers During COVID-19: Pandemic-Era Best Practices
78 minutes

Recorded on: Dec. 16, 2020

Description: Regulatory compliance expert Steven Lynn shares the basics of the COVID-affected supplier relationship, emphasizing the best practices you must incorporate to manage it over time. He discusses:

  • How to structure a pharmaceutical supplier agreement that incorporates specific clauses to assist you in monitoring your supplier during the pandemic;
  • How to use new technology to develop best practices for monitoring and overseeing your supplier partnerships; and
  • How to conduct world-class supplier audits during the pandemic.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Steven Lynn, Executive Vice President of Pharmaceuticals, Regulatory Compliance Associates

Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections
89 minutes

Recorded on: Dec. 9, 2020

Description: GxP expert David Chesney shares best practices for creating effective new SOPs for electronic document management or improving existing SOPs. He discusses:

  • The legal basis of FDA records access authority;
  • The types of documents commonly requested during inspections;
  • The perils of emails as GxP documentation, and how to avoid them; and
  • The impact of the shift to real-time electronic review of documents during inspections.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: David Chesney, Principal and General Manager, DL Chesney Consulting

Drug, Biologics and Combination Products Labeling: Complying with FDA's Most Recent Guidance
58 minutes

Recorded on: Dec. 8, 2020

Description: Food and drug attorney Alan Minsk discusses the FDA’s new labeling guidance on instructions for use (IFU). He covers:

  • The kind of language IFUs should be written in to be patient friendly;
  • What the guidance recommends in terms of voice, commands and sentences;
  • Examples of sample labeling that covers all elements of an IFU from dosage and usage to storage and disposal; and
  • Recommendations the FDA makes in terms of design and layout, such as the use of easy-to-read fonts, sequential numbering and white space.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Alan Minsk, Partner, Arnall Golden Gregory

How Will FDA’s New Approach to CSV Make Implementation Easier?
58 minutes

Recorded on: Dec. 3, 2020

Description: Validation expert Tim Fischer discusses the FDA’s new Computer System Assurance (CSA) and its focus on quality risk management. He covers:

  • Critical risk thinking;
  • Computer systems to which CSA applies;
  • Performance metrics needed; and
  • Transition and next steps.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Tim Fischer, Great Solutions

Clinical Trial Risk Management in the Post-COVID-19, All-Digital World: Predictive Transformation in Quality, Compliance and Risk Management
59 minutes

Recorded on: Dec. 2, 2020

Description: Information systems experts Pradip Banerjee, Brian Friel and Bob Friedman discuss the uses of predictive technologies. They cover:

  • Modern technologies and algorithms to strategize, plan and implement predictive risk management solutions;
  • Digital technologies to help identify, predict and manage risks of the entire clinical trials process;
  • Real-time data monitoring and data integrity issues and solutions; and
  • Technologies that can help prioritize actions to make operations more efficient.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Pradip K. Banerjee, Chairman of the Board and Chief Executive Officer, Brian Friel, Compliance and Risk Specialist, and Bob Friedman, Chief Technologist and Chief Solutions Architect, Xybion

Advertising and Promotion Compliance: Latest Developments and Keys to Successful Compliance with FDA Regulations and Guidance
78 minutes

Recorded on: Dec. 2, 2020

Description: Regulatory experts Stefanie Doebler and Christopher Hanson discuss FDA requirements for promotion — incorporating claims substantiation, fair balance and off-label promotion — and the key differences between drug and device promotion. They cover:

  • The primary requirements for advertising and promotion set forth in the Food, Drug and Cosmetics Act and implementing regulations;
  • The FDA’s recent guidance on promotion consistent with the approved labeling;
  • The scope of the prohibition on preapproval promotion; and
  • The difference between promotion and disease awareness communications.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Stefanie Doebler, Partner, Covington & Burling, and Christopher Hanson, Special Counsel, Covington & Burling

BREXIT’s Impact on Medical Devices: What You Must Do Now to Comply Starting Jan. 1, 2021
71 minutes

Recorded on: Nov. 19, 2020

Description: Quality systems expert Dan O’Leary discusses the coming changes to device certification, obtaining a UK Conformity Assessed (UKCA) mark and registering your device with the Medicines and Healthcare products Regulatory Agency (MHRA). Topics include:

  • Making sense of the UK conformity assessment bodies;
  • The separate rules for Northern Ireland; and
  • Some of the planned changes in the UK regulations.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Dan O’Leary, President, Ombu Enterprises

Ensuring Your Organization’s Research Billing Compliance is Functional
61 minutes

Recorded on: Nov. 19, 2020

Description: Representatives of Mercy Health discuss the challenges of connecting study teams in multiple states to ensure billing efficiency and compliance. They cover:

  • Recent coverage analysis trends;
  • Examples and best practices of communication within an organization to ensure study start-up sets the table for compliant billing decisions;
  • Importance of coverage analysis utilization by multiple teams within an institution to protect the organization and research participants; and
  • Examples of a “living document” that evolves throughout the lifecycle of a clinical trial, including amendments and change requests.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Aubrey Smith and Tiffani Smith, Managers of Business Operations, Mercy Health; Geoffrey Schick, Senior Consultant, WCG Clinical; and Amanda Miller, Manager of Quality and Development, WCG Clinical

Pharmacovigilance Under COVID-19
46 minutes

Recorded on: Nov. 19, 2020

Description: Pharmacovigilance expert Graeme Ladds discusses best practices around resource reductions, safety reporting, labeling, compliance documents and reporting adverse events. He covers:

  • Prioritizing product risks and communicating those risks to regulators during the COVID-19 pandemic;
  • Complying with expedited reporting rules during the health crisis;
  • Creating world-class SOPs, including those that contain exceptions to accommodate COVID-19 issues; and
  • Constructing real-world timelines that take into account compliance requirements around COVID-19.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Graeme Ladds, CEO, PharSafer Associates

Vendor Oversight: Ensuring Regulatory Compliance by Assessing Study Risks
62 minutes

Recorded on: Nov. 17, 2020

Description: Clinical trial operations experts Barry Milton, Andy Lawton and Elvin Thalund discuss the concepts of vendor oversight and risk management under ICH E6(R2). They cover:

  • The intended purpose of ICH regulations to implement industry best practices;
  • How current vendor oversight practices need to evolve to ensure compliance with recent regulatory guidances; and
  • How implementing quality-by-design principles can ensure study risk assessment in your vendor oversight – end-to-end.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Barry Milton, Head of Global Program Management, Novartis Institutes for Biomedical Research; Andy Lawton, Consultant, Risk Based Approach Ltd.; and Elvin Thalund, Director of Industry Strategy, Oracle Health Sciences

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