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: May 16, 2018
Description: Attorney Roseann Termini addresses implications of the opioid crisis for drugmakers, healthcare providers and other regulated firms. She discusses:
- False Claims Act crackdowns on GMP violations and opioid overprescribing;
- Impact of the Senate probe of donations by U.S. opioid manufacturers;
- Lawsuits at state, local and tribal levels;
- Opioid deterrents; and
- New regulations, warnings, dosage limits from the Gottlieb task force.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Roseann Termini, Food and Drug Lawyer
Recorded on: May 15, 2018
Description: Suicide treatment experts Larry Alphs, Jennifer Giddens and David Sheehan present latest trends and developments in measuring suicidal ideation and behavior. They discuss:
- Drug development targeting suicidality;
- What’s new in design and execution of studies of suicidal ideation and behavior;
- Phenotypes in suicidality; and
- Assessments in clinical trials for anti-suicidality treatments.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Larry Alphs, Therapeutic Area Leader, Ortho-McNeil Janssen; Jennifer Giddens, Co-founder & Co-director, Tampa Center for Research on Suicidality; and David Sheehan, Distinguished University Health Professor Emeritus, University of South Florida College of Medicine
Recorded on: May 8, 2018
Description: Food and drug specialist Will Woodlee explains how to take advantage of the many opportunities to communicate with the FDA. He discusses:
- How to avoid a warning letter;
- How to ask sensitive questions;
- Alternatives to direct engagement;
- What to do when your competitor isn’t complying with FDA requirements; and
- Identifying the correct agency point of contact.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Will Woodlee, Partner, Kleinfeld Kaplan & Becker LLP
Recorded on: May 3, 2018
Description: Food and drug law experts Areta Kupchyk and Paul Kim talk about the regulatory landscape for precision/personalized medicine. They discuss:
- Key points in two draft guidance documents;
- The level of evidence the FDA will accept to analytically validate additional or expanded application of next generation sequencing (NGS) tests;
- Pros and cons of various approaches, including implications of binding or non-binding recommendations; and
- FoundationOne CDx (F1CDx), the first breakthrough-designated NGS-based IVD test.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Areta Kupchyk, Partner, and Paul Kim, Partner, Foley Hoag LLP
Recorded on: May 1, 2018
Description: Digital innovation expert Steve McCarthy discusses calculating and managing the total cost of quality using new technology. He covers:
- Benefits and challenges of using cloud platforms and other digital technology in a Quality and/or GXP-regulated environment;
- Economic consequences of an inferior quality management system; and
- How to use digital technology — including cloud platforms — to augment your quality strategy.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Steve McCarthy, VP of Digital Innovation, Sparta Systems
Recorded on: April 27, 2018
Description: IT experts Brian Mundy and Steven Beales discuss the importance of using clinical trial portals. Topics include:
- How clinical trial portals enable you to differentiate yourself from your competition with potential Big Pharma and VC partners;
- How to demonstrate you’ve got the technology solutions in place to efficiently meet milestones, deadlines, and startup times for your clinical trials; and
- How to attract the top sites to participate in your clinical studies.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Brian Mundy, Director of Product Strategy, and Steven Beales, Senior Vice President of IT, WCG ePharmaSolutions
Recorded on: April 26, 2018
Description: Regulatory experts Kellie Combs and Josh Oyster share FDA warning and untitled letters that illustrate the agency’s position on advertising and promotion. They discuss:
- Safety and risk information;
- Communicating pre-approval;
- Describing FDA-approved or -cleared uses; and
- Best practices for promotional review committees.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kellie Combs, Partner, and Josh Oyster, Associate, Life Sciences Group, Ropes & Gray LLP
Recorded on: April 25, 2018
Description: Attorney Eric Babineaux explains the importance of precise wording in clinical trial agreements. He discusses:
- Understanding nuanced and specific contract language;
- The importance of debarment provisions and how to respond to contract qualifiers on debarment certification; and
- Interpreting important indemnification provisions and understanding the differences between “indemnify” and “hold harmless.”
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Eric Babineaux, Legal Counsel, Clintrax Global
Recorded on: April 23, 2018
Description: Cybersecurity specialists Norma Krayem and Michael Werner discuss the rapidly evolving global regulatory landscape. They cover:
- Cybersecurity-triggered changes in interpretation of HIPAA and enforcement by the HHS Office of Civil Rights;
- Cybersecurity as an enterprise risk management issue affecting security, risk and privacy functions in device firms;
- How Department of Homeland Security initiatives, including the Automated Information Sharing (AIS) program, can help you understand the threat from nation-states, non-state actors and other potential attackers; and
- The FDA’s focus on cybersecurity and how it impacts the risk, responsibilities and regulation of companies.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Norma Krayem, Senior Policy Advisor and Co-Chair, Cybersecurity and Privacy Team, Holland & Knight, and Michael Werner, Partner, Holland & Knight
Recorded on: April 19, 2018
Description: Management systems expert Dan O’Leary explains how to comply with U.S. and international standards for personnel training. He discusses:
- The four elements of competency and how to include them in job descriptions;
- The concept and qualifications of a ‘designated individual;’
- Implementing the competence acquisition process using the ISO 10018:2012 model;
- Implementing a training program using the ISO 10015:1999 model; and
- Competence gap analysis and how to close identified gaps.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises LLC
