Simplifying Global Compliance
The Webinar Training Pass
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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!
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Webinar Training Pass
Recorded on: Sept. 14, 2017
Description: FDA experts Wayne Pines, Jill Hartzler Warner and Dan Kracov discuss FDA Commissioner Scott Gottlieb’s first months in office, including:
- What the Gottlieb FDA is likely to continue and what will likely change;
- What unannounced priorities the commissioner may advocate in the future; and
- Gottlieb’s record and regulatory inclinations as well as unfolding events.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Wayne Pines, President, Health Care APCO Worldwide; Jill Hartzler Warner, VP of Regulatory Policy, Catalyst Healthcare Consulting; and Dan Kracov, Partner, Arnold & Porter Kaye Scholer LLP
Recorded on: Sept. 13, 2017
Description: John Balzano, an expert on China’s medical device regulations, explains the current environment for devicemakers doing business in China, including:
- General reforms of China’s administrative system;
- Influence of reforms in other spaces; and
- Reform of the Chinese healthcare system.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: John Balzano, Special Counsel, Covington and Burling, LLP
Recorded on: Sept. 12, 2017
Description: Supplier accreditation experts Connie Conboy, Paul Hugo and Scott Goolsbey outline the benefits of using the MedAccred program to audit and certify suppliers. They cover:
- Meeting FDA requirements for purchasing controls;
- Verifying suppliers’ critical process capabilities;
- Evaluating suppliers’ equipment, personnel and controls; and
- How MedAccred audits differ from quality system audits.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Connie Conboy, Director, Strategy & Business Development, Performance Review Institute; Paul Hugo, Director, Corporate Quality, Global Technologies; and Scott Goolsbey, Supplier Controls Manager, Stryker
Recorded on: Sept. 6, 2017
Description: Health economics and outcomes specialist Jeff Trotter explains the opportunities and pitfalls of using observational studies to show evidence of product safety and efficacy and discusses the impact of the 21st Century Cures Act. He covers:
- The critical link between strategy and operational efficiency in observational studies;
- Setting internal and external expectations for real-world evidence; and
- Best practices for ensuring clinical and commercial collaboration in support of observational studies and patient registries.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jeff Trotter, President, Continuum Clinical
Recorded on: Aug. 31, 2017
Description: Regulatory expert Wayland Rushing explains the requirements of ICH guidance Q3D on elemental impurities in drug products. He covers:
- Comparison of ICH Q3D vs. USP requirements;
- Risk assessment and gathering information from suppliers;
- Analytical strategies and techniques; and
- Challenges associated with testing.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Wayland Rushing, Director of Scientific Affairs, EAG Labs
Recorded on: Aug. 24, 2017
Description: Quality systems expert Dan O’Leary analyzes the FDA’s two guidances on cybersecurity for medical devices. He covers:
- A design control framework for cybersecurity;
- The role of software verification and validation in cybersecurity;
- Identifying expected cybersecurity documents in the design history file; and
- Postmarket information, sources, and effect on cybersecurity.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises, LLC
Recorded on: Aug. 22, 2017
Description: Biologics experts Suzanne Sensabaugh and Nitisha Pyndia explain the FDA’s view of interchangeability in biosimilars. They discuss:
- The most challenging areas of product development — including technical issues of similarity in purity and potency — and how to comply;
- How the FDA evaluates immunogenicity, a key factor entailing communication and cooperation with scientific colleagues;
- The chemistry of structural features; and
- Understanding the differences between interchangeability and biosimilarity.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Suzanne M. Sensabaugh, President and Principal Consultant, and Nitisha Pyndiah, Consultant, HartmannWillner
Recorded on: Aug. 15, 2017
Description: Former director of the FDA Investigations Branch Ricki Chase explains FDA’s GMP guidance for combination products, focusing on the often-overlooked topic of design control. She discusses:
- How design controls apply to combination products, including biologic/device and drug/device combinations;
- How already available information can help speed new products to market; and
- Using human factor studies to support combination product submissions.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Ricki Chase, Director, Lachman Consultant Services, Inc.
Recorded on: Aug. 14, 2017
Description: FDA regulatory expert Jim O’Reilly discusses how the FDA plans to implement the variety of provisions in the 21st Century Cures Act and how those plans will affect manufacturers. He covers:
- How the FDA Science Board's new standards can lead to much faster product development approvals;
- How the FDA will allocate the $500 million authorized by Congress; and
- The role of the agency’s new Office of Translational Sciences, which governs the bench-to-clinical process.
Presentation: Download the presentation
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Speaker: Jim O’Reilly, Professor, University of Cincinnati College of Medicine
Recorded on: Aug. 9, 2017
Description: CDRH officials Francisco Vicenty and Daniel Walter discuss the center’s new Culture of Quality program, its goals and how it will affect inspections. They cover:
- The disconnect between compliance and quality;
- New metrics for evaluating device quality;
- Accelerated approval of premarket submissions; and
- CDRH’s new voluntary pilot program for devicemakers to help the center identify quality indicators.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Michael Gaba, Shareholder, Polsinelli LLP; Francisco Vicenty, Program Manager for the Case for Quality, Office of Compliance, Center for Devices and Radiological Health; and Daniel Walter, Chief of the Foreign Enforcement Branch, Division of International Compliance Operations, CDRH