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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Webinar Training Pass
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
Recorded on: April 18, 2018
Description: Attorneys J.J. Saul and Julie Letwat discuss best practices for online pharmacies can protect themselves from e-commerce threats. Topics include:
- How rogue drug websites affect your operation and professional responsibilities;
- Impact on existing laws and regulations;
- How resources such as the Alliance for Safe Online Pharmacies (ASOP) can help you protect yourself;
- The risks consumers run when buying prescriptions and devices online; and
- Working with consumer groups to protect your customers.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: J.J. Saul, Partner, and Julie K.Letwat, Counsel, Faegre Baker Daniels LLP
Recorded on: April 11, 2018
Description: Product development expert Anthony Parise explores the concept of risk-based thinking, what it means for the medical device industry and how to use it to improve operations. He discusses:
- How to better understand operational risk and risk management;
- How risk management processes drive new ways of looking at compliance in operations;
- The relationship between ISO 13485:2016 and risk management; and
- How to leverage common tools for regulatory compliance and product performance/safety.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Anthony Parise, Product Manager-Life Sciences, EtQ
Recorded on: April 10, 2018
Description: Attorney Katlin Backfield outlines recent regulatory developments regarding REMS and discusses possible outcomes. She covers:
- Commissioner Gottlieb’s emphasis on drug pricing and how it will affect the development of single shared-system REMS;
- Bills in the congressional pipeline and their odds on passage; and
- Recent trends in FDA’s REMS-related enforcement.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Katlin Backfield, Attorney and Consultant, Backfield PLLC
Recorded on: March 29, 2018
Description: Product management experts Daniel Matlis and Mike Jovanis discuss change management best practices and how to leverage technology for an effective and efficient change control process, including:
- Roles and responsibilities;
- A framework to systematically assess global operational and regulatory impact;
- Structuring and implementing change releases in a global environment;
- Streamlining processes between departments; and
- Gaining better intelligence to improve decisionmaking.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Daniel R. Matlis, Founder and President, Axendia, and Mike Jovanis, Vice President-Vault Quality, Veeva Systems