Recorded on: July 16, 2020

Description: Learning strategy specialists John Constantine and Kent Malmros discuss the benefits of micro-learning and a practical approach to applying it into your existing GXP training program. The cover:

• How micro-learning can boost your GxP training compliance;
• How to overcome the common misconceptions about micro-learning; and
• How to implement micro-learning into your GxP training program.

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Speakers: John Constantine, Senior Vice President of Talent Solutions, Orchestrall, and Kent Malmros, Senior Director, Vault Training at Veeva Systems

Recorded on: July 15, 2020

Description: Statistical methods expert Steven Walfish presents tools for developing statistical sampling plans. He covers:

• The differences between confidence and reliability in the sample size;
• Incorporating statistical assumptions, such as independence, as part of all sampling plans; and
• How variance in the population impacts the sample size necessary to establish objective evidence.

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Speaker: Steven Walfish, President, Statistical Outsourcing Services

Recorded on: July 15, 2020

Description: Pharma regulatory expert Pradip Banerjee shows how to use risk-prediction software, benchmarking and new robotic process automation software cloud platform using AI and machine learning algorithms. He covers:

• How to move compliance risk and quality management processes into the cloud with full integration with operating systems;
• How to create a strategic digital future workplace with proactive automated real-time compliance monitoring, AI-driven compliance risk prediction and mitigation to enable continuous data integrity and eChain of custody of information in real time; and
• How to improve informed executive decisionmaking by implementing compliance risk management.

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Speaker: Pradip Banerjee, CEO, Xybion

Recorded on: July 14, 2020

Description: Regulatory expert Jon Gimbel presents best practices for meeting postmarket requirements of the new EU-MDR. He discusses:

• Elements of required postmarket reports;
• Linking all reports so they can be updated together; and
• Common Notified Body audit findings.

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Speaker: Jon Gimbel, Executive Director, Regulatory and Quality Systems

Recorded on: June 25, 2020

Description: Clinical trial management experts Irina Petrova and Anna Yanaeva discuss reasons trial spending might exceed proposed costs and how to navigate shifting study needs while maintaining a budget. They cover:

• Determining expendable costs and expenses;
• Case studies on successful budget planning;
• Statistics on exceeding, meeting and running below budget; and
• Focusing on programmatic goals to direct spending.

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Speakers: Irina Petrova, Director of Clinical Operations and Anna Yanaeva, Head of Business Development, OCT Clinical

Recorded on: June 24, 2020

Description: Device regulatory expert Tina Krenc presents best practices and guidance to meet the revised risk management requirements in ISO 14971:2019. She discusses:

• How regulators and auditors will look at things differently;
• Procedural changes to make in addition to changing SOP references; and
• Rethinking the way you’ve been doing risk management.

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Speaker: Tina Krenc, Principal Consultant, KTA Compliance Consulting

Recorded on: June 23, 2020

Description: Pharmacovigilance expert Catherine Baldridge discusses REMS critical components as well as the importance of advanced planning and proper resource allocation to prepare you for the ultimate success of your REMS programs. She covers:

• Tools to have in place and topics to discuss when bringing on a contract research organization (CRO) partner and/or developing an in-house program;
• The recommended quality and compliance processes you need to consider during an implementation, including audit recommendations and legal considerations; and
• The importance and value of cross-functional engagement when developing and implementing a program, such as collaboration with your commercial and supply teams.

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Speaker: Catherine Baldridge, Owner/Founder, Essential Pharmacovigilance

Recorded on: June 18, 2020

Description: Device expert Dan O’Leary explains how the draft guidance considers hazards in the MR environment, what to include in a hazard analysis and which standards must be followed to demonstrate device safety. He covers:

• How to best document your results;
• The importance of accurate safety labeling;
• The application of ISO 14971:2019 to MR environment hazards; and
• Product safety standards in the context of ISO 14971:2019.

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Speaker: Dan O’Leary, President, Ombu Enterprises

Recorded on: June 16, 2020

Description: A team of legal experts shares practical guidelines and tips on maintaining compliance during the COVID-19 pandemic while also discussing how to manage any potential investigations from regulatory bodies. They cover:

• Identifying concerns and risk;
• Developing investigation protocols;
• Implementing audit methods; and
• Prioritizing investigation and compliance tasks.

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Speakers: Gail Rodgers, Partner, Nancy Sims, Of Counsel, Mason Hubbard, Associate, and Adam Pié, Associate, DLA Piper

Recorded on: June 10, 2020

Description: Recall experts Seth Mailhot and Tom Brockhaus identify the exceptions, required records and various reporting methods and their issues to help you ensure any corrections, removals, recalls or closures have the minimum impact on your business. They cover:

• The benefits and methods of data cleansing mail files, such as Coding Accuracy Support System (CASS) and National Change of Address (NCOA) to avoid wasting resources and to increase delivery rates of important recall communications;
• The differences between first-class and certified mail and considerations on what method to use;
• Understanding the different approaches to conducting effectiveness checks, including use of automated telephony feedback systems; and
• The importance of training call center agents on topics such as recall sensitivity, handling of escalations and identification of incidents.

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Speakers: Seth Mailhot, Partner, Husch Blackwell, and Tom Brockhaus, Senior Vice President, Recall Results