Recorded on: March 18, 2021

Description: Cynthia Schnedar ensures that you understand how the FDA conducts its postmarket safety surveillance and what you must do to ensure postmarket adverse reporting inspection readiness. She explains:

• The FDA Adverse Event Reporting System (FAERS) and how the FDA evaluates the information in the database;
• Nuances of the FDA Program Guide CHAPTER 53 - Postmarketing Surveillance and Epidemiology: Human Drug and Therapeutic Biological Products Program: 7353.001;
• How the FDA uses its MedWatch program to provide information on mandatory reporting by manufacturers; and
• What type of reports a manufacturer must submit to the FDA when deviation from current good manufacturing practice regulations occur.

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Speaker: Cynthia Schnedar, Executive Vice President of Regulatory Compliance, Greenleaf Health

Recorded on: March 18, 2021

Description: Sundeep Agarwal addresses manufacturers’ challenges in designing a compliant AI framework that is safe, effective and beneficial for human health around the world, including:

• Introduction to artificial intelligence (AI);
• Overview of the regulatory framework of AI in the U.S. and EU;
• AI-based software classification; and
• Quality system and good machine learning practices (GMLP).

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Speaker: Sundeep Agarwal, General Manager of Compliance & Regulatory Affairs, Datt Mediproducts, India

Recorded on: March 16, 2021

Description: Susan M. Proulx, PharmD, Managing Director, Drug Safety at Leaderboard Branding is an international leader in preventing medication errors due to brand name confusion. She shares:

• How the prescreening process relates to attributes that may contribute to medication errors in naming drugs;
• Suggested methods of evaluating the risk of medication errors related to naming;
• The FDA process for notifying applicants that have similar names in the FDA queue; and
• The phonetic and orthographic computer analysis (POCA) criteria and its use in evaluating name similarity.

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Speaker: Susan Proulx, Managing Director of Drug Safety, Leaderboard Branding

Recorded on: March 10, 2021

Description: The FDA restarted inspections last summer under a new guidance and during this webinar FDA inspections expert Kalah Auchincloss shares how assessments are proceeding and what criteria the FDA is using to determine which sites are inspected.

• FDA criteria for in-person inspections;
• Alternatives to on-site inspections;
• Preparation for FDA inspections; and
• The likelihood of foreign inspections resuming.

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Speaker: Kalah Auchincloss, Senior Vice President and Deputy General Counsel, Greenleaf Health, Inc.

Recorded on: Feb. 18, 2021

Description: A panel of experts discusses how to modernize and digitally transform your manufacturing operations to support quality metrics, review by exception and smartsourcing. They share:

• Training as a strategic function;
• The differences between content standards and integration standards;
• Elearning standards and why they are important; and
• Choosing the right vendors.

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Speakers: Kent Malmros, Sr. Director of Vault Training, Veeva Systems; Lexie Pieper, Head of Quality, Celularity; John Constantine, Consultant, Orchestrall; Amy Benton, Vice President of Information Technology, Travere Technologies

Recorded on: Feb. 17, 2021

Description: A panel of experts explains how to prepare, organize and streamline manufacturing auditing processes using a risk-based approach. They’ll discuss:

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

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

Recorded on: Feb. 11, 2021

Description: Pradip Banerjee and Dhanasbri Gudi, discuss how to leverage compliance, quality and digital lab information systems from the cloud. They’ll cover how to:

• Enable tracking and tracing from collection site to healthcare providers and regulatory bodies;
• Create a new paradigm for the post-COVID-19 world of holistic digital quality and compliance management;
• Always be ready for e-Audit, e-Sourcing and e-Inspections; and
• Bring results to market at rapid speeds with full regulatory compliance in the digital workplace.

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Speakers: Dr. Pradip Banerjee, Chairman of the Board and Chief Executive Officer, Xybion; Dr. Dhanasbri Gudi, Laboratory Management Specialist, Xybion

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: 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