Recorded on: Sept. 24, 2020

Description: R&D expert Pradip Banerjee discusses how to unify all quality compliance and operating processes. He covers:

• Rapid quality transformation imperatives;
• New operating model for Web X.0 World; and
• Case examples.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Pradip K. Banerjee, Chairman of the Board and Chief Executive Officer, Xybion

Recorded on: Sept. 22, 2020

Description: Quality systems expert Tim Fischer discusses the concept of Quality 4.0 and what it entails. He covers:

• Digital transformation initiatives;
• Operational tools; and
• A digital system strategic roadmap.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Tim Fischer, Principal Partner, Great Solutions

Recorded on: Sept. 17, 2020

Description: Quality systems expert Dan O’Leary explains how to use analysis of variance (ANOVA) principles to examine quality data: He discusses:

• The underlying idea that makes ANOVA work;
• The data collection issues you should plan;
• How to get access to ANOVA in Excel; and
• Interpreting the result.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Dan O’Leary, President, Ombu Enterprises

Recorded on: Sept. 17, 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.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: David Harrison, Principal Consultant, CSV Compliance

Recorded on: Sept. 16, 2020

Description: Top officials of the Clinical Trials Transformation Initiative (CTTI) share the organization’s 10-year plan for strengthening trials’ evidence generation abilities. They discuss the five points of CTTI’s strategy:

• Patient-centered and accessible;
• Fully integrated with health processes;
• Designed with a quality approach;
• Maximally leveraging available data; and
• Improve public health.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Pamela Tenaerts, Executive Director, and John Alexander, Co-Chair, Clinical Trials Transformation Initiative

Recorded on: Sept. 16, 2020

Description: Data analysis experts Angela Slocum and Mitesh Devarapally discuss technology platform solutions for improving data quality and access. Takeaways include:

• Processes for defining data review objectives in today’s data chaos environment;
• How a centralized clinical data platform and analytics can be used to support data review objectives; and
• Best practices for adapting data review processes to a centralized data platform and workbench.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Angela Slocum, Senior Director of Implementation Consulting, and Mitesh R. Devarapally, Principal Medical Data Reviewer, eClinical Solutions

Recorded on: Sept. 15, 2020

Description: Clinical trial data specialist Ken Lownie shares key insights from Agatha Life Science’s State of Remote Monitoring survey. He discusses:

• The imperatives driving remote monitoring as a practice;
• Understanding the technology alternatives; and
• Calculating the costs and savings of remote monitoring.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Ken Lownie, Head of North American Operations, Agatha Life Sciences

Recorded on: Sept. 10, 2020

Description: A team of life sciences regulatory experts explores the expanded access terrain, provides an update on current regulatory changes and addresses possible policy solutions. Topics include:

• The existing legal and regulatory landscape driving expanded access;
• Recent congressional changes and how the FDA is implementing those changes;
• The FDA’s voluntary efforts to increase use of expanded access; and
• Policy considerations underlying the expanded access debate, such as monitoring and tracking of expanded access outcomes and adverse events.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: David Farber, Lisa Dwyer and Preeya Pinto, Partners, King & Spaulding

Recorded on: Aug. 20, 2020

Description: Device regulatory expert Dan O’Leary explains the new harmonized coding system and form for adverse event reporting. He covers:

• The code set structures;
• Planned changes to the FDA’s reporting form;
• The relationship between the IMDRF codes and the current FDA codes; and
• The EU Manufacturer’s Incident Report (MIR) and the IMDRF codes it uses.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Dan O’Leary, President, Ombu Enterprises

Recorded on: Aug. 20, 2020

Description: A panel of quality experts discusses a practical approach to harmonizing quality processes that help accelerate technology implementation and adoption. Topics include:

• A proven framework for harmonizing business processes;
• Guidance on navigating complex organizations to gain support; and
• Best practices for transforming quality management systems.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Paola DePaso, Director, Vault Quality, Veeva Systems; Jan Paul Zonnenberg, Partner, Pharmaceutical & Life Sciences Companies, PwC; Anastasia Wengrowski, Manager, Vault Quality, Veeva Systems; and Vishaka Rajaram, Director, Pharmaceutical & Life Sciences Companies, PwC