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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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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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: 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
Recorded on: Oct. 30, 2017
Description: Quality assurance expert Susan Leister outlines the risk management requirements in the latest revision of ICH E6 – Good Clinical Practice. She discusses:
- Specific challenge areas: sponsor quality management system, software validation, risk management;
- The hidden implications of certain changes; and
- How to achieve full and effective compliance.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Susan Leister, Director of Quality Assurance, Technical Resources International
Recorded on: Oct. 27, 2017
Description: Supplier contract specialist Courtney Stevens walks you through the essentials of supply contracts. She covers:
- How to approach a contract negotiation;
- What every contract must include;
- Insurance clauses and certificates of insurance; and
- Audit provisions for further protection.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Courtney Stevens, Senior Attorney-Risk Management and Loss Control, MedMarc Insurance Group