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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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

Recorded on: Jan. 24, 2023

Description: Ellen Weiss — PCM Trials’ vice president, in-home solutions, decentralized clinical trials — explains how deploying a team of properly trained mobile research nurses can transform your remote trials, making them more efficient and more diverse, while improving participant retention. You’ll understand:

• Which qualifications mobile research nurses must have for the biggest trial efficiencies and benefits;
• Which specific activities they are authorized to carry out in the patient’s home;
• The specialized training mobile research nurses must have; and
• How to ensure adherence to good clinical practice (GCP) and constraint-induced therapy (CIT) when using a mobile nursing workforce.

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Speaker: Ellen Weiss, Vice President, In-Home Solutions, Decentralized Clinical Trials, PCM Trials

Recorded on: Jan. 19, 2023

Description: Susan Schniepp moderates a discussion with four of the most respected professionals in the field that takes a deep dive into the most important issues faced in developing and effectively utilizing world-class audits. They discuss:

• How to use a risk-based approach to audits;
• The importance of quality culture and regulatory requirements identifying quality culture;
• Steps to take when a quality issue is identified through the audit process; and
• The best practices for documenting and tracking resolutions to identified issues.

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Speakers: Susan Schniepp, Distinguished Fellow, Regulatory Compliance Associates; Seyed Khorashahi, Executive Vice President of Medical Device and CTO, Regulatory Compliance Associates; Steve Lynn, Executive Vice President of Pharmaceuticals; Michael de la Torre, CEO, Redica Systems