Recorded on: March 24, 2021

Description: Tom Comstock presents LNS Research’s latest findings on the intersection of Industrial Transformation (IX) and Quality 4.0 specific to life sciences organizations, including pharmaceutical, biotechnology, medical device and more. He discusses:

• How you can improve your quality monitoring and outcomes;
• Why your data and its analysis are core to both Industrial Transformation IX and Quality 4.0;
• The role of executive leadership in transformation and the quality team as a key business partner; and
• What the leading cause of failure is in meeting your quality objectives and how you can avoid it.

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Speakers: Tom Comstock, Principal analyst, LNS Research; Stephen McCarthy, Vice President of Digital Innovation, Sparta Systems

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: 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