Recorded on: Nov. 2, 2023

Description: Jay Crowley, vice president of medical devices and solutions at USDM Life Sciences, will explain the role that UDI systems and their associated data play as a foundation for solving emerging global regulatory, commercial, and quasi-regulatory use issues for your company’s medical devices. You’ll learn:

• How UDI systems are emerging globally;
• How UDI systems can be used to support regulatory and commercial purposes;
• The FDA’s expectations for data alignment through UDI systems; and
• The need for alignment and reuse of data across various systems and outputs.

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Speaker: Jay Crowley, Vice President, Medical Device Service and Solutions, USDM Life Sciences

Recorded on: Oct. 31, 2023

Description: The term “Quality Culture” has been around for years, but few companies have mastered what it means or how to implement and measure a culture of quality in a GMP-regulated environment.  This webinar will help provide attendees with a better understanding of the concepts behind quality culture, as well as provide some strategies for implementation and metrics for measuring performance.

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Speaker: Sarah Tanksley, President and CEO, Tanksley Consulting Group Inc.

Recorded on: Oct. 26, 2023

Description: This webinar, presented by a panel of FDA-watchers and regulatory experts, looks at what can we expect the FDA to seek to achieve in the coming year?  What priorities will the agency set? What will the 2024 budget enable the FDA to achieve? What will the regulatory and political environment be like? How will companies need to adjust?

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Speakers: Wayne Pines, APCO Worldwide; Steven Grossman, HPS Group; Cathy Burgess, Alston & Bird; Josh Oyster, Ropes & Gray; and Lowell Zeta, Hogan Lovells

Recorded on: Sept. 28, 2023

Description: Steven Walfish provides real-world examples of the assumptions and risks associated with calculating sample sizes in drug, device and combination product design. You’ll learn how to:

• Develop a clear understanding of how to implement sound statistical methods in verification and validation activities.
• Understand why specific standards, such as ANSI Z1.4, should not be used for validation activities.
• Master game-changing shortcuts that will simplify your sample size calculation efforts and ultimately ensure better outcomes.

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Speaker: Steven Walfish, President, Statistical Outsourcing Services

Recorded on: Sept. 28, 2023

Description: True track and trace of individual items throughout the supply chain is necessary and may be more involved than just what is needed from compliance. This webinar helps you understand:

• Why supply chain traceability and product authentication capabilities can be essential to protect the healthcare medical device.
• High-profile use cases and real-world examples of issues that have occurred and the steps taken to solve the problem. Proactively including these techniques can prevent issues from occurring in the first place.
• How to maximize the value of compliance barcodes and leverage them as a strong authentication layer.

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Speakers: Dave DeJean, Vice President Global Strategic Accounts, Systech; and Steve Tallant, Director of Market Development, Systech

Recorded on: Aug. 24, 2023

Description: Covering an overview of a quality risk management system for medical devices, this webinar provides you with the confidence needed to identify, reduce and eliminate failure modes and more:

• Learn the FDA’s specific expectations for risk management;
• Come away with a better understanding of the ISO 14971 risk management process;
• Grasp best practices for deploying risk control and mitigation methodologies; and
• Become familiar with how to use the many different types of FMEAs.

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Speaker: Eliot Zaiken CQE, CMDA, CQA, President, Technology Device Enterprises, Medical Device/Combo Product Quality/Regulatory Consultant

Recorded on: Aug. 10, 2023

Description: Peter Knauer, a CMC and RA expert, walks through statistical approaches that have been previously used and accepted by the FDA. This webinar helps you:

• Understand device reliability;
• Learn the current FDA thinking around reliability;
• Discover risk-based approaches to determining reliability, such as FTA; and
• Undertake probabilistic determinations of reliability.

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Speaker: Peter Knauer, Managing Partner, Sage BioPartners

Recorded on: July 19, 2023

Description: Dave Petrich, vice president of quality and regulatory at the Landrich Group, discusses the critical relationship between design control and risk management throughout the entire medical device development process. He’ll provide:

• A better understanding of key definitions for design control and risk management;
• The latest regulations associated with design control and risk management, including 21 CFR 820.30;
• Lessons learned from issues that lead to 483s/warning letters; and
• Best practices for design control and risk management, such as FDA recommendations in Design Control Guidance for Medical Device Manufacturers.

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Speaker: Dave Petrich, Vice President of Quality and Regulatory, Landrich Group

Recorded on: July 12, 2023

Description: Jim Polarine, a senior technical service manager at STERIS Corporation, offers a comprehensive action plan for designing a holistic cleaning and disinfection program, including:

• Cleaning and disinfection best practices;
• The latest advancements in application equipment and methods of cleaning;
• A comprehensive understanding of how to develop a holistic contamination; and control strategy that includes an effective risk-based cleaning and disinfection program.

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Speaker: Jim Polarine, Senior Technical Service Manager, STERIS Corporation

Recorded on: June 22, 2023

Description: Life sciences training experts discuss leveraging and incorporating the latest trends and innovations to enhance your learning programs and drive business success, including:

• The emerging trends in training and development in life sciences;
• Best practices for considering new technologies or modalities for your training programs; and
• Tips for measuring the effectiveness of your training programs.

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Speakers: Christian Torstensson, Director of Learning and Development, Sanofi; Kari Borroel, MBA, Head of Operations Quality Learning & Development and Operations GxP Learning, AstraZeneca/Alexion Rare Disease; John Constantine, SVP, Orchestrall Inc.; and Kent Malmros, VP, Training Strategy, Veeva Systems