Recorded on: Feb. 10, 2021

Description: A panel of FDA experts share the changes they expect to see from the agency’s administrative shift. They’ll cover:

• What changes are expected at the FDA with the new administration;
• Policies and programs organizations should consider implementing;
• Day-to-day adjustments that could help your team navigate the changes; and
• Insights into shifts around drug and device regulation, enforcement, drug pricing and healthcare innovation.

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Speakers: Wayne Pines, Member, APCO Worldwide’s International Advisory Council and President of Health Care; Marc Scheineson, Partner, Alston & Bird LLP; Esther Krofah, Executive Director, FasterCures; Lowell Schiller, Chief Legal and Regulatory Officer, Aetion

Recorded on: Feb. 9, 2021

Description: Contamination prevention specialist Jim Polarine discusses ways to maintain cleaning procedures during the pandemic. He covers:

• Lessons learned from FDA warning letters and 483s;
• Industry best practices for disinfecting during the COVID-19 pandemic;
• Managing fungal and bacterial spore excursions; and
• The latest advances in application equipment and cleaning methods.

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Speaker: Jim Polarine, Senior Technical Service Manager, STERIS

Recorded on: Jan. 27, 2021

Description: FDA submissions expert Judity Meritz outlines the key information needed for an FDA emergency use authorization (EUA) application for a medical device. She discusses:

• The scope of an EUA;
• What the FDA looks for in the crucial risk-benefit section;
• How the EUA’s criteria for safety, performance and labeling differ from the FDA’s regular medical device clearance and approval process; and
• The FDA’s thought process — and concerns raised — in recent EUA submissions.

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Speaker: Judith Meritz, Partner, Meritz & Muenz

Recorded on: Jan. 27, 2021

Description: China regulatory expert Grace Fu Palma discusses the China National Medical Products Administrations developing clinical trial regulations. She covers:

• Different clinical pathways and how to decide which pathway to choose;
• Key areas you need to pay focus on to shorten clinical trials and approval times;
• Whether your devices qualify for the real-world data/study Hainan program and how to get into the program; and
• Key considerations on the feasibility and justification of overseas clinical data acceptance.

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Speaker: Grace Fu Palma, CEO, China Med Device

Recorded on: Jan. 26, 2021

Description: A panel of experts discusses using technology to increase study startup speed. They cover:

• Standardizing processes across multiple sponsors;
• Market dynamics and industry solutions; and
• Leveraging data for full study optimization.

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Speakers: Sujay Jadhav, Global Vice President, Oracle Health; Larissa Comis, Product Lead, Cognizant Healthcare and Life Sciences; David Morin, Director of Research, Holston Medical Group; Jimmy Bechtel, Vice President, Society of Clinical Research Sites; Patricia Lorusso, Professor of Medical Oncology, Yale School of Medicine

Recorded on: Jan. 21, 2021

Description: Regulatory expert Christy Coleman shares how virtual MDSAP audits are being conducted and what you must do to ensure effective ones. She discusses:

• Real-world examples of remote MDSAP audit experience;
• Best practices for managing remote MDSAP audits;
• Virtual MDSAP audit challenges and how to mitigate them, including issues with video conferencing and file-sharing technologies; and
• Alternatives when technology does not work as expected.

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Speaker: Christy Coleman, Vice President of Regulatory, Irrimax

Recorded on: Jan. 19, 2021

Description: Risk management expert Amanda McFarland discusses applying risk-based decisionmaking to ensure the long-term impacts of your company’s current decisions are fully understood. She covers:

• Ways to integrate quality risk management (QRM) into your quality systems, such as change control and investigations, and how integration can benefit your organization;
• Risk management tools available to you to meet regulatory requirements, such as process hazard analysis (PHA), risk evaluation and mitigation (REM), hazard analysis critical control point (HACCP), and FMEA; and
• Recognizing the critical QRM regulations that apply to pharma, such as ICH 9, ICH Q10, ISO 14644 and Annex 1.

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Speaker: Amanda McFarland, QRM and Microbiology Senior Consultant, ValSource

Recorded on: Jan. 14, 2021

Description: Computer system validation expert David Harrison shares best practices and available options for validating spreadsheets. He discusses:

• FDA examples of noncompliance and regulatory concerns with respect to 21 CFR 210-211, 21 CFR Part 11 and 21 CFR Part 820;
• How to determine spreadsheet validation gaps the FDA targets;
• How to choose an approach for efficient and repeatable validation that fits into your traditional QA and validation processes; and
• How to plan, manage and resource an effective project.

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Speaker: David Harrison, Principal Consultant, CSV Compliance

Recorded on: Jan. 13, 2021

Description: Industrial-organizational psychologist Ginette Collazo explains how to write SOPs that minimize human error. She discusses:

• How to prepare an outline and develop world-class SOPs;
• The interrelationship between SOPs, quality and regulatory compliance;
• How to create and maintain a procedure that minimizes human error; and
• Use of electronic information networks for procedural access.

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Speaker: Ginette Collazo, CEO, Human Error Solutions

Recorded on: Dec. 17, 2020

Description: Quality systems expert Dan O’Leary presents methods for reporting adverse events in both the U.S. and the EU. He discusses:

• Key requirements in adverse event reporting to regulators in the U.S. and the EU;
• Important differences between reporting systems in both regions;
• Recent changes in the adverse event reporting forms in the U.S. and the EU; and
• Comparisons of the content expectations in the forms for both systems.

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Speaker: Dan O'Leary, President, Ombu Enterprise