Recorded on: March 11, 2020

Description: Device systems expert Dan O’Leary explains how to predict misuse errors and make risk management plans that comply with the revised ISO 14971:2019. He discusses:

• What you must know about the regulatory status of the standards in the U.S., EU and Canada;
• How to comply with the FDA Center for Devices and Radiological Health’s approach to usability engineering;
• How to incorporate the concepts of formative and summative evaluation; and
• Which inputs you must add to your user interface specification.

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Speaker: Dan O’Leary, President, Ombu Enterprises

Recorded on: Feb. 27, 2020

Description: FDA regulatory expert Scott Lassman explains the requirements of pharmaceutical exclusivity. He discusses:

• The new standard governing the scope of 3-year clinical investigation exclusivity;
• Orphan drug exclusivity; and
• Current legislative proposals.

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Speaker: Scott Lassman, Principal, Lassman Law & Policy

Recorded on: Feb. 25, 2020

Description: Trade attorney Jennifer Diaz discusses strategies for resolving FDA and Customs and Border Patrol (CBP) issues. She covers:

• Analysis of important recent enforcement actions;
• Customs and Border Protection detention and seizure processes;
• Mitigating and aggravating factors in enforcement; and
• Submitting a petition for relief.

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Speaker: Jennifer Diaz, President, Diaz Trade Law and Diaz Trade Consulting

Recorded on: Feb. 20, 2020

Description: EU medical device regulatory expert James Pink describes the role of the Person Responsible for Regulatory Compliance (PRRC) under the new EU-MDR. He discusses:

• The relationship between the PRRC and the strategy set for regulatory compliance;
• Evaluating whether your corporate structure is ready to ensure supervision and control of products to achieve EU regulatory compliance; and
• The importance of organizational design to ensure the various roles participating in compliance are understood and coordinated.

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Speaker: James Pink, Vice President, NSF Health Sciences Medical Devices, Europe

Recorded on: Feb. 19, 2020

Description: Quality assurance expert Susan Schniepp discusses how to streamline your audit approach so you can identify quality issues. She covers:

• How to use a risk-based approach to audits;
• Understanding 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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Speaker: Susan Schniepp, Independent Consultant

Recorded on: Feb. 18, 2020

Description: FDA enforcement expert Karla Palmer discusses recent trends in FDA enforcement of pharmacy compounding regulations. She covers:

• Changes brought about in draft and final guidances;
• What enforcement actions the FDA has taken against compounders to date and what could lie down the road;
• What the FDA is looking for right now; and
• The interplay between FDA and state regulation of outsourcing facilities and compounding pharmacies.

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Speaker: Karla Palmer, Director, Hyman Phelps & McNamara

Recorded on: Feb. 12, 2020

Description: Quality management expert Patricia Santos-Serrao discusses how connecting quality management technologies can increase efficiency. She covers:

• How to build a robust risk management protocol that automates vital actions in other systems;
• How to optimize document controls;
• Implementing a learning management system that ensures compliance; and
• Incorporating business processes into technology to automate tasks and reduce risk of critical tasks being missed.

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Speaker: Patricia Santos-Serrao, Director, Product Strategy, MasterControl

Recorded on: Feb. 6, 2020

Description: Quality management expert Bethany Kearney presents methods for transitioning to digital quality management methods. She discusses:

• What an enterprise cloud quality management system solution should include;
• Using quality data to move from reactive compliance to proactive performance; and
• Utilizing emerging technologies to improve decisionmaking.

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Speaker: Bethany Kearney, Industry Best Practices CoE, Professional Services, Sparta Systems

Recorded on: Jan. 28, 2020

Description: Industrial-organizational psychologist Ginette Collazo discusses how to comply with regulations on cannabis-containing products. She covers:

• How the FDA is regulating cannabis, including how GMPs apply to the medical cannabis industry;
• How Canada and Europe are regulating cannabis, including how to comply with comparable GMP regulations from different jurisdictions; and
• Best practices for dealing with personnel requirements, process controls, procedures development, quality controls and analytical testing in cannabis production.

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Speaker: Ginette Collazo, Founder, Human Error Solutions

Recorded on: Jan. 23, 2020

Description: Data specialists Mary Jo Lamberti and Francis Kendall discuss the use of real-world evidence (RWE) in drug development. Topics include:

• Types of technology used to access or collect RWE;
• The key drivers for change and the adoption of RWE; and
• The potential of RWE and how it may be used across the clinical development pipeline.

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Speakers: Mary Jo Lamberti, Associate Director of Sponsored Research, Tufts CSDD, and Francis Kendall, Senior Director, Cytel