Recorded on: March 15, 2023

Description: Scott Thiel, global head of regulatory policy and intelligence for Hologic, and Jeff Ballyns, director of regulatory strategic planning for innovation at Becton Dickinson and a veteran of the FDA’s Center for Devices and Radiologic Health (CDRH) share techniques you can use to provide objective evidence of compliance. They explain:

• Where the AI/ML technology knowledge gaps are — in industry and the FDA — including what AI/ML can and cannot do when it comes to medical device quality, regulatory and compliance information;
• Common issues and strategies for closing knowledge gaps, including how to optimize the use of AI and ML;
• What to do differently — or not do differently — when it comes to integrating AI/ML into your quality system or production process, including how integration meshes with your SOPs; and
• What issues the FDA sees when reviewing premarket submissions and inspecting facilities with AI/ML-enabled medical devices and AI/ML that supports the quality system and/or production.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Scott Thiel, Global Head of Regulatory Policy and Intelligence, Hologic; and Jeff Ballyns, Director, Regulatory Strategic Planning for Innovation, Becton Dickinson

Recorded on: March 8, 2023

Description: Eric Henry and Christopher Gates explain the regulatory expectations for cybersecurity and how to craft your design controls practices to execute and defend in compliance with those expectations. They cover:

• How cybersecurity activities fit into traditional design controls and safety risk management for medical devices when integrating into quality management systems;
• What the FDA is already addressing in inspections from its new draft cybersecurity guidance;
• How to address postmarket cybersecurity activities during inspections; and
• Common themes in the current library of cybersecurity regulations, standards and guidance.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Eric Henry, Senior Quality Systems and Compliance Advisor, King & Spalding LLC; and Christopher Gates, Director of Product Security, Velentium

Recorded on: March 7, 2023

Description: Grace McNally, a senior vice president of regulatory compliance at Greenleaf Health, and a 33-year veteran of the FDA, explains everything you need to know and do regarding the agency’s ongoing use of remote tools, including:

• The FDA’s approach to regulatory oversight during the public health emergency, including its use of remote assessment tools;
• The important differences between mandatory and voluntary assessments;
• FDA priorities and key guidances and other policy documents that describe remote regulatory assessments; and
• Center for Drug Evaluation and Research compliance activity based on remote regulatory assessments.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Grace McNally, Senior Vice President, Regulatory Compliance, Greenleaf Health

Recorded on: Feb. 22, 2023

Description: This interactive webinar discusses how to build, maintain, and deploy a modern role-based training matrix to demonstrate compliance. Topics of discussion include:

• Organizing your training plans that deliver maximum efficiency;
• Creating a training plan that supports the varying learning needs of your organization; and
• Aligning the right content with the right people at the right time to improve learning outcomes.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Christian Torstensson, Director of Learning and Development, Sanofi; Nicole Donovan, Director of Organizational Development, Tolmar; John Constantine, SVP, Orchestrall Inc.; and Kent Malmros, Sr. Director, Vault Training, Veeva Systems

Recorded on: Feb. 16, 2023

Description: David L. Chesney explains everything you need to know about inspection management so you’ll be prepared when the FDA arrives. He shares:

• What the FDA must do to conduct an inspection lawfully;
• What the FDA may not do — by law — during an inspection;
• What an FDA Form 483 is and what may trigger its issuance, plus how to respond effectively if you receive one; and
• The enforcement options the FDA can use and the risks each present to your company.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: David L. Chesney, Principal and General Manager, DL Chesney Consulting

Recorded on: Feb. 15, 2023

Description: Half of the effectiveness of your CAPA depends on how well you write it. In this advanced compliance writing webinar, you learn:

• The difference between root cause analysis and failure investigation;
• How to plan for a systematic investigation of discrepancies to prevent recurrence;
• The blueprint for expert root cause analysis; and
• Failure investigation pitfalls with FDA warning letter review.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Judith Meritz, Life Sciences Regulatory Consultant, Meritz & Muenz LLP

Recorded on: Feb. 9, 2023

Description: Industry thought leader Kara Quinn dives deep into the concept of quality culture and the role data integrity plays in it. She explains:

• How the FDA measures quality culture through the lens of warning letters citing data integrity failures;
• FDA inspection trends related to quality and data integrity;
• How to comply with the FDA’s guidance on data integrity by taking a back-to-basics approach; and
• How to differentially apply FDA’s guidance to electronic vs. paper-based systems.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Kara Stockett Quinn, Consultant

Recorded on: Feb. 8, 2023

Description: Dave Petrich, vice president of quality and regulatory at the Landrich Group, shares everything you must know to improve your design and process validation to ensure the safety, quality and integrity of your medical devices, including:

• Best practices in design and process validation;
• The regulatory basis for design and process validation; and
• Trends in 483s and warning letters that impact both design and process validation.

Presentation: Download the presentation

Transcript: Download the transcript

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

Recorded on: Feb. 1, 2023

Description: Due to the ongoing Quality Management Systems (QMS) regulatory changes, the healthcare or Medtech industry is well aware and confused about the changing requirements and standards. Sundeep Agarwal discusses:

• Planning and strategy for EQMS implementation;
• The basic components of today’s QMS enabling remote audits and remote work culture;
• Why EQMS is vital today; and
• How to Choose the right EQMS.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Sundeep Agarwal, Medical Device Expert & Consultant

Recorded on: Jan. 26, 2023

Description: Two lawyers in Ropes & Gray’s Life Sciences Regulatory and Compliance practice — Kellie Combs and Sarah Blankstein — share what you must know about qualifying criteria, what data or other information the FDA may expect, when to initiate discussions with the agency and best practices for securing the benefits, explaining:

• The meaning of key terms, including “serious condition,” “available therapies” and “unmet medical need”;
• Eligibility criteria, including data-generation requirements;
• Timing and content considerations for designation requests and applications for expedited approval programs; and
• How to qualify for multiple programs.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Kellie Combs, Partner, Ropes & Gray; and Sarah Blankstein, Counsel, Ropes & Gray