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

Recorded on: Jan. 22, 2020

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. 21, 2020

Description: Regulatory expert Grace Fu Palma provides an update on medical device regulatory reform in China. She discusses:

• New postmarket surveillance regulations and implications in adverse events and recalls reporting;
• What the regulations and requirements forecast for overseas inspections; and
• Common issues in GMP compliance.

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Speaker: Grace Fu Palma, CEO, China Med Device

Recorded on: Jan. 14, 2020

Description: Compliance experts Cynthia Schnedar and Liz Oestreich discuss issues surrounding data integrity. Topics include:

• Developing an organizational culture of quality that ensures data integrity;
• FDA enforcement activity; and
• Recent data integrity failures in the news.

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Speakers: Cynthia Schnedar, Executive Vice President, and Liz Oestreich, Vice President, Greenleaf Health

Recorded on: Jan. 10, 2020

Description: GxP expert David Chesney shares best practices for creating effective new SOPs for electronic document management or improving existing SOPs. He discusses:

• The legal basis of FDA records access authority;
• The types of documents commonly requested during inspections;
• The perils of emails as GxP documentation, and how to avoid them; and
• The impact of the shift to real-time electronic review of documents during inspections.

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Speaker: David Chesney, Principal and General Manager, DL Chesney Consulting, LLC

Recorded on: Dec. 18, 2019

Description: : Consultant and former FDA investigator Ricki Chase explains how to navigate the FDA’s Adverse Event Reporting System. She discusses:

• The difference between serious unexpected and serious expected events;
• Common inspection observations related to adverse events; and
• What not to report.

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Speaker: Ricki Chase, Executive Director, Lachman Consultant Services