Recorded on: Sept. 8, 2022

Description: Get control of your data by learning the basics of developing best practices and SOPs that turn inspection nightmares into routine management tasks. You’ll cover:

• The legal basis of FDA records access authority, including what FDA can’t access;
• Types of documents commonly requested during inspections;
• Problems and pitfalls to avoid; and
• The Top 10 questions to ask about your archival process.

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Speaker: David L. Chesney, Principal, General Manager, DL Chesney Consulting, LLC

Recorded on: Aug. 25, 2022

Description: Without proper due diligence, life sciences companies may wind up with a returned product that does not meet the necessary standards for quality. This webinar covers:

• Regulatory requirements for raw material suppliers;
• Definitions of differ types of materials;
• Different risk attributes; and
• How to consider risk attributes to manage suppliers using a risk-based approach.

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Speaker: Bob Mehta, Principal Consultant, GMP ISO Expert Services

Recorded on: Aug. 10, 2022

Description: This webinar enables you to understand and comply with the FDA’s gene and cell therapy requirements and avoid common errors, so you can maintain your products’ critical quality attributes and bring them to market. You’ll learn:

• FDA requirements for comparability studies for gene and cell therapy products;
• Best practices for risk analysis and mitigation using comparability studies; and
• How to design an effective comparability protocol for a gene or cell therapy product.

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Speakers: Scott R. Burger, MD, Principal, Advanced Cell & Gene Therapy; and William E. Janssen, PhD, Principal, WEJ Cell and Gene Therapy Consulting Services

Recorded on: Aug. 9, 2022

Description: Legal and regulatory expert Michael Gaba details the avenues that you can take to achieve a successful premarket review from the FDA, including:

• FDA premarket review pathways;
• Breakthrough device designation and STeP; and
• Medical coverage of innovative technology (MCIT) pathway.

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Speaker: Michael Gaba, Vice Chair of FDA Practice, Polsinelli

Recorded on: Aug. 3, 2022

Description: John E. Lincoln, principal of J.E. Lincoln and Associates shares how to develop, validate and refine your pharmaceutical process validation processes to ensure their reliability, consistency and efficacy when you:

• Understand the key points in the FDA’s process validation guidance document;
• Appreciate the value to your company when you put these principles into practice; and
• Recognize the key process, equipment (production/test/lab), hardware and software, and QMS/21 CFR 11 verification and validation activities.

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Speaker: John E. Lincoln, Principal, J.E. Lincoln and Associates

Recorded on: Aug. 2, 2022

Description: This webinar shows you how to incorporate cybersecurity into your quality system and defend it to interested third parties. You’ll stay compliant, bolster your device defenses and protect patients, not to mention stay out of security breach-related headlines. You’ll learn:

• How cybersecurity relates to design controls and the quality system more generally;
• Key tips for defending cybersecurity during an FDA inspection or notified body audit, even when the investigator or auditor is not familiar with cybersecurity concepts; and
• How addressing cybersecurity risk relates to product risk management.

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Speaker: Eric Henry, Senior Quality Systems and Compliance Advisor in the FDA and Life Sciences Practice, King & Spalding

Recorded on: July 28, 2022

Description: James Pink, senior director, medical at Element Materials Technology, shares how you can stay on top of the EU-MDR requirements through a carefully designed strategy for regulatory compliance. He’ll explain:

• The regulatory framework around the EU-MDR, including common specifications, guidances, harmonized standards and interacting EU laws;
• How to develop an effective and value-added strategy for regulatory compliance, including developing tools and systems to track regulatory updates, setting equivalence requirements and managing changes to standards and medical state-of-the-art good practices; and
• How to plug into those aspects of EU regulations you may not have known exist but are essential, including the forthcoming Artificial Intelligence Act, cybersecurity frameworks, data protection law and hazardous substance requirements.

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Speaker: James Pink, Senior Director, Medical, Element Materials Technology

Recorded on: July 27, 2022

Description: Ellen Weiss, PCM Trials’ vice president of in-home solutions and decentralized clinical trials (DCT), explains the positive effects hybrid and DCT methods have on clinical trials now and into the future, helping you fully realize the advantages for your trials, sharing:

• Clinical trial-related lessons learned from the COVID-19 pandemic;
• The most-requested and most-used activities in home visit programs today; and
• How to realize the benefits of decentralized clinical trials going forward.

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Speaker: Ellen Weiss, Vice President of In-home Solutions and Decentralized Clinical Trials, PCM Trials

Recorded on: July 13, 2022

Description: Communications compliance expert Mark Senak walks you through what you must know and do to avoid OPDP enforcement action, sharing the latest trends and FDA research so you can understand the most frequent mistakes and avoid the greatest risks. He discusses:

• The most common ad and promo violations that trigger regulatory action by the FDA;
• The most recent trends with respect to enforcement and different types of promotional communications, especially in response to direct-to-consumer (DTC) promotions; and
• How digital and social promotional communications have impacted enforcement, including via Twitter and Facebook.

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Speaker: Mark Senak, Senior Vice President and Partner, FleishmanHillard

Recorded on: June 28, 2022

Description: A team of quality management and technology solutions experts explains how a predictive system can identify and mitigate compliance risks and ensure uniform quality and compliance across every level and site within your organization. They’ll share how to:

• Effortlessly monitor the regulatory landscape, correct issues found in your corrective and preventive action (CAPA) and audit programs, and avoid negative consequences with a predictive compliance solution;
• Easily conduct proactive quantitative analysis that furthers your data literacy and minimizes uncertainty with built-in data-driven compliance — in the form of a quantitative score — to take the guesswork from your regulatory project planning and compliance activities; and
• Save time and money when you eliminate unnecessary monitoring and reviewing of public data sources.

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Speaker: Kamal Biswas, President and COO, Xybion; Heidi Krueger, Director of Quality Assurance, Xybion; Bob Friedman, Chief Technology Officer, Xybion; Joe Kalina, Director of Marketing, Xybion