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.
Recorded on: Nov. 12, 2019
Description: Clinical research experts Kerry Dyson and Kris O’Brien share real-world case studies that show how patient engagement leads to successful data capture and better outcomes. They discuss:
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Speakers: Kerry Dyson, Global Head of Clinical Research; Kris O’Brien, Vice President of Client Strategy and Development; CROMSOURCE
Recorded on: Nov. 5, 2019
Description: Design control statistical expert Steven Walfish shares best practices for understanding the requirements for statistical techniques and how they impact the design control process and sample size issues. He discusses:
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Speaker: Steven Walfish, president, Statistical Outsourcing Services
Recorded on: Oct. 31, 2019
Description: Human error reduction expert Ginette Collazo shares best practices for minimizing human error and regulatory citations in manufacturing. She discusses:
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Speaker: Ginette Collazo, chief executive officer, Human Error Solutions
Recorded on: Oct. 30, 2019
Description: Technology experts Jon Carter, Catie Roland and Mark Tomlinson share the differences between EDC and eSource and offer guidelines to help select solutions that suite clinical trial needs. They discuss:
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Speakers: Jon Carter, Product Manager; Catie Roland, Program Manager; Mark Tomlinson, Senior Director of Technology Operations; Cmed Technology
Recorded on: Oct. 29, 2019
Description: Regulatory expert Alan Minsk shares best practices for adhering to the recent Instruction for Use (IFU) guidance and expected implications on new drug applications and biologics license applications. He discusses:
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Speaker: Alan Minsk, partner, Arnall Golden Gregory LLP
Recorded on: Oct. 15, 2019
Description: Device expert Connie Hoy shares best practices for responding to nonconformities found during an audit inspection. She discusses:
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Speaker: Connie Hoy, Founder, Hoy & Associates Regulatory Consulting
Recorded on: Oct. 10, 2019
Description: Risk management expert Mark Levy shares best practices for having a solid process for compliance with current law and guidance in regard to medical product off-label use and marketing. He discusses:
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Speaker: Mark Levy, Litigator and Trial Attorney, Eckert Seamans
Recorded on: Oct. 9, 2019
Description: Quality systems expert Dan O’Leary shares insights to help find solutions to the five highest-risk areas that prompt 483s and warning letters. He discusses:
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Speaker: Dan O’Leary, President, Ombu Enterprises, LLC
Recorded on: Oct. 9, 2019
Description: Technology expert Filip Matakovic shares best practices for making a paperless transition, including how updated guidelines and new technology have lowered the hurdles and streamlined the transition to going electronic. He discusses:
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Speaker: Filip Matakovic, Vice President and General Manager, Site Services Group, MedPoint Digital
Recorded on: Oct. 8, 2019
Description: Regulatory experts Dirk Rodgers, Susanne Somerville and Joseph Lipari share best practices for staying up-to-date on the changing pharma regulatory landscape along with VRS solutions. They discuss:
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Speakers: Dirk Rodgers, Regulatory Strategist, Founder of RxTrace.com; Susanne Somerville, Chief Executive Officer, Chronicled; Joseph Lipari, Director, Cloud Products, Systech
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