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: March 31, 2016
Description: Consultants Glen Potvin and Lesley Stewart describe a proven approach to uncover and address data integrity issues within companies and their partner networks. They discuss:
- How to establish a “right to win mentality” through proactive steps and surveillance activities;
- How to characterize the scale and scope of issues;
- How to design and deploy the remediation strategy; and
- Best practices for tailoring solutions to the problems identified.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Glen Potvin, Senior Director, and Lesley Stewart, Principal Consultant, Quintiles Consulting
Recorded on: March 31, 2016
Description: Attorneys Anuj Desai and Alan Minsk explain how to minimize risks of FTC and FDA enforcement for the use of native advertising techniques. They cover:
- The FTC definition of deceptive advertising;
- How to ensure disclosure language is clear and visible; and
- How to apply FDA rules on labeling and promotion in the absence of guidance specific to native advertising.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Anuj Desai and Alan Minsk, Partners, Arnall Golden Gregory
Recorded on: March 30, 2016
Description: Industry analysts Daniel Matlis and Ethan Smith show you how innovative life science companies have addressed the challenges of increasingly externalized operations. They discuss:
- Why recent regulatory trends are putting current manufacturing and supply chain processes at risk;
- How to improve visibility and management of quality across your supply chain; and
- Which strategies adopted by leading life science companies have led to increased quality in a global and outsourced environment.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Daniel R. Matlis, President, Axendia, and Ethan Smith, Director of Product Strategy, Vault QualityDocs, Veeva Systems
Recorded on: March 24, 2016
Description: Regulatory counsel Kurt Karst explains how to use the 505(b)(2) drug approval path to fast-track new products. He discusses:
- The nuances and shifts in the development of the 505(b)(2) route to approval;
- Current FDA interpretations affecting 505(b)(2) applications;
- Pitfalls to avoid; and
- Secrets to interpreting new legal challenges to the 505 process, including citizen petitions, looming lawsuits and the assignment of therapeutic equivalent codes.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Kurt Karst, Director, Hyman, Phelps & McNamara
Recorded on: March 23, 2016
Description: Drug application expert Aloka Srinivasan provides an overview of how to organize an ANDA to make first-cycle approval a reality. She covers:
- The best ways to communicate with the Office of Generic Drugs;
- The best ways to prepare for meetings with the FDA, if granted; and
- Complex generics and the challenges facing the industry.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Aloka Srinivasan, Principal Consultant, PAREXEL
Recorded on: March 15, 2016
Description: Global regulatory affairs specialists Fernando Ferrer and Silvia Bendiner outline the business and regulatory environment in Latin America and provide situation analysis and strategies for organizations seeking sustained growth in life-science markets. They discuss:
- Key regulating bodies in Latin America;
- Growth markets and emerging markets in the region;
- Economic outlook in various countries; and
- GMP requirements.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Fernando Ferrer, Head of Global Consulting in Business and Operations, Multinational Partnerships, LLC and Silvia Bendiner, Director of Regulatory Affairs for Latin America, Mapi Group
Recorded on: March 10, 2016
Description: Noted process analysts Herman and Erich Bozenhardt discuss the FDA’s new guidance on emerging manufacturing technology applications. They cover:
- How to participate in the FDA’S new early engagement program;
- Four classes of technology innovations; and
- Renovation to remediate bioburden, cross contamination, and containment.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Herman Bozenhardt, President, Bozenhardt Consulting Services, LLC and Erich Bozenhardt, Process Group Lead, Integrated Process Services, Inc.
Recorded on: Feb. 29, 2016
Description: Regulatory specialist Ravi Harapanhalli reviews the current climate for fixed-dose drug combinations and challenges for their developers. He discusses:
- Pre-formulation, formulation, and analytical challenges and strategies associated with fixed-dose combination products;
- Technical challenges associated with developing fixed-dose combination products for various routes of administration; and
- Current and likely future of the regulatory scheme for developing fixed-dose combination products.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Ravi Harapanhalli, Principal, FDAPharma Consulting
Recorded on: Feb. 25, 2016
Description: Quality systems expert Dan O’Leary interprets FDA regulations for managing environmental conditions in device manufacturing. He discusses:
- Environmental conditions that could affect product quality;
- Linkage to other requirements, such as contamination control and buildings;
- Correction and corrective action related to environmental controls; and
- Sampling plans for environmental control and monitoring.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, Ombu Enterprises, LLC
Recorded on: Feb. 25, 2016
Description: Compliance expert John Avellanet examines recent trends in CDRH’s Quality System Regulation enforcement and looks ahead to possible future activity. He discusses:
- Predictions for 2016 and 2017;
- FDA enforcement focus points for 2016 and their business implications; and
- How to prepare your compliance program for a new wave of enforcement initiatives.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: John Avellanet, Founder, Cerulean Associates, LLC