Simplifying Global Compliance
The Webinar Training Pass
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.
Select webinars have been pre-approved by RAPS as eligible for up to 1.5 credits toward a participant’s RAC recertification. Please enter keyword RAPS below for a list of eligible on-demand webinars.
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Webinar Training Pass
Recorded on: Dec. 14, 2017
Description: A panel of industry experts discusses the FDA’s plans and priorities for 2018 and beyond. They cover:
- Opioids;
- The new drug approval process;
- FDA transparency; and
- Orphan drugs and rare diseases.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Wayne Pines, President, Health Care, APCO Worldwide; Steven Grossman, President, HPS Group, LLC; and Brian E. Harvey, Principal Consultant, Brian E Harvey LLC
Recorded on: Dec. 6, 2017
Description: Device development expert Anthony Parise explains how to use risk management tools to secure your supply chain. He discusses:
- How risk management tools can open new windows into compliance;
- Leveraging risk in compliance, product performance and safety;
- Risk management tools your competitors are using; and
- Turning suppliers into compliance and quality partners.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Anthony Parise, Life Sciences Product Strategist, Verse Solutions
Recorded on: Dec. 5, 2017
Description: Biotech expert Keith Chidwick untangles the complexities of the new European Drug Assessment Policy for Biological Medicines. He discusses:
- Eligibility and requirements to enter the centralized procedure;
- Game-changing issues, including comparability, the main CMC reason for refusal;
- Strategic validation; and
- Best practices for biosimilars in the EU.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Keith Chidwick, Technical VP, PAREXEL Consulting
Recorded on: Nov. 28, 2017
Description: Regulatory compliance expert Paul Daniel presents five key considerations in deciding the best way to set up an enterprise-wide monitoring system. He discusses:
- Multi-site security issues;
- International monitoring challenges;
- IT infrastructure considerations; and
- Dealing with different types of sites within the same system.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Paul Daniel, Senior Regulatory Compliance Expert, Vaisala
Recorded on: Nov. 16, 2017
Description: A panel of experts discusses the regulatory outlook for drugmakers under the current administration. They cover:
- Gottlieb’s big-picture approach to drug development;
- Making the clinical end of drug development more efficient and effective;
- Integrating real-world evidence in clinical and regulatory decisions; and
- Initiatives to combat the opioid epidemic.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Wayne Pines, President, Health Care, APCO Worldwide; Douglas W. Balogh, Director, Navigant; Kevin Madagan, Partner, Reed Smith
Recorded on: Nov. 15, 2017
Description: Veeva Vice President Melonie Warfel and Solution Consultant Richard Chu discuss using systems that improve manufacturing processes without risking compliance pitfalls. They cover:
- Managing, finding, and sharing critical content to enable internal and external collaboration with all critical stakeholders;
- Providing real-time visibility into documents and processes, and gaining complete control over audits and inspections; and
- Monitoring and reporting to mitigate compliance risks.
The webinar also includes a demonstration of Veeva’s Vault Suite.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Melonie Warfel, Vice President, Global Medical Device & Diagnostics, and Richard Chu, Solution Consultant, Veeva Systems
Recorded on: Nov. 14, 2017
Description: Quality systems expert Dan O’Leary parses two new final guidances on changes to 510(k) devices. He discusses:
- The FDA’s plans for evaluation of changes;
- Role of risk management (ISO 14971:2007) in the evaluation process; and
- How to establish the quality record to support your decision.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises LLC
Recorded on: Nov. 8, 2017
Description: Device industry veteran Jon Speer discusses best practices for CAPA processes. He covers:
- How to avoid the most common problems with CAPA;
- How CAPA connects to other QMS processes; and
- The impact of risk management on CAPA.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jon Speer, Founder and VP of QA/RA, Greenlight Guru
Recorded on: Nov. 7, 2017
Description: Regulatory expert Tim Hunter presents a model for reimbursement integration designed to increase commercial success. He discusses:
- How to turn FDA-required data into an argument for health economics;
- How your FDA negotiations will impact your market; and
- How to evaluate reimbursement needs vs. regulatory or clinical requirements.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Tim Hunter, Vice President, Musculoskeletal Clinical Regulatory Advisers, LLC
Recorded on: Oct. 31, 2017
Description: Regulatory expert David Rosen discusses how principal investigators and sponsors can develop a strategy for dealing with FDA inspections. He covers:
- How BIMO inspections are started and conducted;
- What the BIMO team is looking for in terms of following proper protocols for patient recruitment;
- FDA-recommended best practices in execution of consent forms; and
- Whether patient volunteers are actually eligible participants in a clinical trial.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: David Rosen, Partner, Foley & Lardner LLP