Recorded on: Oct. 5, 2021

Description: Mahnu Davar, a partner at Arnold and Porter in the life sciences and healthcare regulatory practice, explains the next-generation enforcement approach in consumer diagnostics, including:

• The basics of FDA regulation of diagnostics products and components, including FDA’s enforcement discretion policy for lab-developed tests;
• How FDA applies medical device regulatory requirements to test kits and component developments; and
• How the COVID-19 pandemic and its lessons learned may shape how regulators will deal with issues involving consumer diagnostics going forward.

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Speaker: Mahnu Davar, Partner, Arnold & Porter

Recorded on: Sept. 23, 2021

Description: Through this webinar you’ll discover how to use artificial intelligence and machine learning to progress beyond descriptive analysis to predictive analytics, eventually getting to prescriptive analytics. You’ll learn about:

• The possibilities of analytics;
• Developing better quality programming; and
• Mitigating risk.

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Speaker: Dawn Irons, Senior Product Manager, MasterControl

Recorded on: Sept. 22, 2021

Description: Discover the tips and tricks that will help you streamline your spreadsheet validation process for quick-and-final FDA approval, including:

• FDA examples of noncompliance and regulatory concerns with respect to 21 CFR 210-211, 21 CFR Part 11 and 21 CFR Part 820;
• Determining spreadsheet validation gaps the FDA targets;
• Choose an approach for efficient and repeatable validation that fits into your traditional QA and validation processes; and
• Generating spreadsheet specifications and qualification protocols.

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Speaker: David Harrison, Principal Consultant, CSV Compliance Limited

Recorded on: Sept. 21, 2021

Description: Kristin Davenport and Rujul Desai, both of counsel at Covington & Burling LLP, will share what you must know and do to get your devices included in the FDA’s Breakthrough Devices Program and Safer Technologies Program (STeP) for Medical Devices, explaining:

• STeP and breakthrough criteria, including the submission timing and content requirements for obtaining a breakthrough designation or inclusion into STeP;
• Benefits of breakthrough designation and inclusion into STeP, including expediting approval time; and
• Pathway for nationwide coverage of breakthrough devices, and its impact on your device development program.

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Speakers: Kristin Davenport, Of Counsel, Covington & Burling LLP; and Rujul Desai, Of Counsel, Covington & Burling LLP

Recorded on: Sept. 15, 2021

Description: This webinar explains how Agios Pharmaceutical and eClincial Solutions worked collaboratively to build a new system that provides operational data insight and automation of previously manual tasks. They’ll discuss:

• Why existing CTMS are not optimized for companies working in highly outsourced models;
• What are the different options available to companies evaluating CTMS-like technology solutions; and
• How and why Agios Pharmaceuticals selected a partnership approach to find a “right-sized” CTMS data and analytics platform.

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Speakers: Avery McMurray, Manager, Agios Pharmaceutical; and Rob Musterer, Head of eClinical Product Management Team

Recorded on: Aug. 26, 2021

Description: Supply chain disruptions along with new and pending regulations have only increased the pressure. Medical device and diagnostic (MD&D) companies must make big changes or risk noncompliance. This webinar explains how to do just that, covering:

• Changes you must make to the way your products are manufactured and serviced to stay compliant;
• Drivers of change – robotics, healthcare policy, consumer access; and
• Acceleration of digital implementation due to COVID-19.

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Speakers: Cris Salinas, Medtech Strategy, Salesforce; Prashanth Rajendran, ComplianceQuest CEO; and Dik Hoogmoed, Director, QA/RA, Canon Medical Systems Europe

Recorded on: Aug. 16, 2021

Description: Sue Marchant, director of product, machine learning and artificial intelligence (AI) at MasterControl, will detail how the technology can investigate corrective and preventative actions (CAPAs) with minimal human involvement and pinpoint the root causes of common complaints. She’ll cover:

• What data is needed to feed an AI system and where to find it;
• Using AI to identify risk and optimize manufacturing;
• How to get corporate management buy-in and implement an AI system.

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Speaker: Sue Marchant, Director of Product, Machine Learning and Artificial Intelligence, MasterControl

Recorded on: Aug. 12, 2021

Description: Regulatory compliance experts share insights on the likely structure of blended on-site and virtual inspections and audits — and explore ways to merge these best practices to develop an efficient, effective model — covering:

• Virtual audit practices;
• On-site audit practices; and
• Models for post-pandemic audits.

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Speakers: Steven Lynn, Executive Vice President, Pharmaceutical, Regulatory Compliance Associates Inc; Seyed Khorashahi, Executive VP of Medical Device and CTO, Regulatory Compliance Associates Inc; and Susan Schniepp, Distinguished Fellow,Regulatory Compliance Associates Inc.

Recorded on: Aug. 5, 2021

Description: Amanda McFarland, a QRM and microbiology senior consultant with ValSource, Inc., clarifies the regulations relative to risk management and how to apply the principles of QRM, sharing:

• Best practices related to QRM program development and execution, including process, people and documentation;
• Ways to integrate QRM into your quality systems such as change control and investigations and how integration can benefit your organization; and
• The PIC/S Aide-Memoire on QRM and how you can prepare for a QRM program inspection.

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Speaker: Amanda McFarland, QRM and Microbiology Senior Consultant with ValSource, Inc.

Recorded on: July 27, 2021

Description: Learn how manufacturers transformed their quality processes with a modern cloud solution and achieving increased speed, reduced costs and driving seamless collaboration across partners, suppliers and customers. The speakers will discuss:

• Top considerations for evaluating quality cloud solutions;
• Key benefits for manufacturers, partners, suppliers and customers; and
• Lessons learned across evaluation, implementation and adoption.

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Speakers: Sandra Rodriguez, Senior Industry Analyst, Axendia and Ashley Wentworth, Director, Vault Quality, Veeva Systems