Recorded on: Oct. 20, 2020

Description: FDA regulatory expert Keith Webber explains the FDA’s most important coronavirus-related guidance. He covers:

• GMP manufacturing considerations;
• Supply chain drug and biologics inspections; and
• COVID-19 vaccine guidance.

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Speaker: Keith Webber, Senior Associate, Lachman Consultant Services

Recorded on: Oct. 15, 2020

Description: Medical device regulatory expert Dan O’Leary explains the importance of medical device reliability and the tools and methods you need to prove it. He discusses:

• The concept of maintainability;
• Availability as the combination of reliability and maintainability;
• Distinguishing between safety and reliability; and
• The relationship between reliability and warranty cost.

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Speaker: Dan O'Leary, President, Ombu Enterprises

Recorded on: Oct. 14, 2020

Description: Regulatory expert Karla Palmer shares tips on navigating the regulation of outsourcing facilities and compounding activities. She discusses:

• The significant differences between Sections 503A and 503B of the Food, Drug and Cosmetic Act (FDCA);
• The FDA’s position with respect to compounding pharmacies and outsourcing facilities considering drug shortages caused by the COVID-19 pandemic;
• The implications of recent enforcement actions the FDA has taken against compounders; and
• The important interplay between the FDA and states concerning the regulation of outsourcing facilities and compounding pharmacies.

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Speaker: Karla Palmer, Attorney, Hyman, Phelps & McNamara

Recorded on: Oct. 14, 2020

Description: Clinical trial experts Jim Coutcher, Matt Stannard and Qi Li discuss how to use real-world data (RWD) to improve trial recruitment, clinical operations and postmarket surveillance. They cover:

• Approaches to rapid site selection, cohort identification and patient recruitment;
• How to leverage comprehensive, longitudinal patient health records to improve clinical research, health economics and outcomes research, and market access; and
• Where the industry is headed with concepts such as siteless randomized clinical trials, artificial cohorts for comparator arms and the role of RWD in artificial intelligence.

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Speakers: Jim Coutcher, Senior Director/Principal, Global Head of Enriched Studies, Real-World Solutions, IQVIA; Matt Stannard, Life Sciences Adviser, InterSystems; and Qi Li, Physician Executive, InterSystems

Recorded on: Oct. 13, 2020

Description: Quality management experts Bob Mehta and Lou Sanatore explain how a streamlined and precise supplier agreement can improve your time to market. They discuss:

• How to hold suppliers accountable to ensure they meet quality and compliance regulations and company requirements;
• How to demonstrate management and control over suppliers’ compliance during an audit or inspection;
• What criteria to use to create a quality agreement if the law and/or regulatory requirements are not clear; and
• What criteria to use to establish a process for periodic reviews of the quality agreement.

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Speakers: Bob Mehta, Principal Consultant, GMP ISO Expert Services, and Lou Sanatore, Principal Solution Engineer, ComplianceQuest

Recorded on: Oct. 13, 2020

Description: Clinical trial experts Raymond Nomizu and Gail Hinkson discuss the benefits of using electronic data management systems for virtual trial monitoring. They cover:

• Cost savings from remote monitoring;
• Operational challenges of transition to electronic systems; and
• How sponsors can help their sites make the transition.

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Speakers: Raymond Nomizu, Co-Founder and CEO, Clinical Research IO, and Gail Hinkson, CEO, Pinnacle Clinical Research

Recorded on: Sept. 30, 2020

Description: Regulatory affairs experts Kim Young and Monir El Azzouzi discuss the direct impact of UDI data requirements for multiple stakeholders and approaches considered across the industry to implement systems and processes. They cover:

• Implications for manufacturers of increased visibility by regulators;
• Compliance timelines of various UDI initiatives underway around the world; and
• How to leverage UDI data to drive internal regulatory intelligence.

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Speakers: Kim Young, Director of Global Regulatory Intelligence, Instem, and Monir El Azzouzi, CEO, Easy Medical Device

Recorded on: Sept. 30, 2020

Description: Medical device regulatory experts Seth Olson and Susan Tiedy-Stevenson present the different FDA pathways to premarket approval. They discuss:

• 510(k), De Novo, PMA and EUA considerations;
• The effect of the newly proposed VALID Act;
• Software as a medical device; and
• FDA presubmission programming and strategies for informal modes of communication.

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Speakers: Seth Olson, FDA Medical Device Attorney, Susan Tiedy-Stevenson, Senior Director of Regulatory Sciences, Hogan Lovells

Recorded on: Sept. 29, 2020

Description: GMP compliance expert Sabine Paris discusses cleaning validation requirements set by the FDA and EU authorities for permitted daily exposure (PDE). She covers:

• The new requirements of EMA, PIC/S and ASTM PDE guidelines;
• The complex derivation of PDEs;
• Important aspects of PDE reports; and
• The risk identification in a multipurpose facility.

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Speaker: Sabine Paris, Pharmacist, Senior GMP Expert, Chief Editor of GMP Compliance Adviser

Recorded on: Sept. 24, 2020

Description: Regulatory compliance expert Kalah Auchincloss shares her insights on FDA inspections during the pandemic. She discusses:

• Developments in FDA inspections from March 2020 to July 2020;
• The agency’s August 2020 inspections guidance; and
• What the FDA’s inspection plans are going forward.

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