Recorded on: May 29, 2020

Description: Global compliance expert John McKay discusses how to continue operations under pandemic conditions when working with Chinese and Indian suppliers. He covers:

• Remote and desktop audits;
• Methods to prevent drug shortages; and
• CAPA for suppliers to implement.

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Speaker: John McKay, CEO and Chief Compliance Officer, Q1 Associates

Recorded on: May 28, 2020

Description: International standards expert Eamonn Hoxey examines recent and upcoming changes to international medical device guidelines and regulations. He discusses:

• The relationship between ISO 13485 and 21 CFR 820;
• The relationship between ISO 13485 and EU-MDR;
• Implications of the reconfirmation of ISO 13485:2016 on quality management systems requirements for medical devices; and
• The future direction of generic management system requirements, including ISO 9001.

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Speaker: Eamonn Hoxey, Technical Writer, Trainer and Consultant

Recorded on: May 27, 2020

Description: Clinical researcher Marina Malikova examines how changes to the international good clinical practice guideline have affected trials. She discusses:

• New sections on investigator responsibilities and the substantial new sponsor section on quality management;
• Implementation of revised regulatory guidelines, including those affecting globalization issues;
• Introduction of risk-based quality management; and
• Development of SOPs, including those on validation and electronic records.

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Speakers: Marina Malikova, Assistant Professor of Surgery and Executive Director of Surgical Translational Research, Operations and Compliance, Boston University School of Medicine

Recorded on: May 21, 2020

Description: Supply chain experts Megan Biernat and Steve Tallant discuss Merck’s approach to supply chain security. They cover:

• How the company uses blockchain technology to create a secure link between physical and digital;
• How it leverages digital eFingerprint technology; and
• A next-generation approach to digitally protect and connect pharmaceutical products.

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Speakers: Megan Biernat, Technical Analyst, Merck, and Steve Tallant, Senior Director of Market Development, Systech

Recorded on: May 20, 2020

Description: Medical device regulatory experts Kim Young and Chris Nichols discuss ways to improve the efficiency of regulatory operations information management. They cover:

• How to integrate the critical aspects of EU-MDR compliance;
• What you must consider when deploying a sustainable EU-MDR compliance framework;
• How to avoid challenges and setbacks when searching for the right technology and tools; and
• Modernizing processes, technologies and tools.

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Speakers: Kim Young, Instem Director of Global Regulatory Intelligence and Chris Nichols, Regulatory Solutions Specialist, Instem

Recorded on: May 19, 2020

Description: Clinical operations and compliance experts discuss methods for conducting trials under the current pandemic conditions. They cover:

• Shifting FDA and IRB guidelines;
• Technology options for supporting clinical trials; and
• Home health and direct-to-patient options.

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Speakers: Kim Kundert, Vice President of Operations, VirTrial, Robin Marcus, Chief Strategy Officer, GlobalCare Clinical Trials and Melanie Flores, Vice President of Compliance, IntegReview

Recorded on: May 14, 2020

Description: Medical device expert Dan O’Leary discusses how Microsoft Excel can help predict outcomes. He covers:

• Using Excel to generate random numbers;
• Examining the relationship between probability density functions and cumulative density functions; and
• Applying Excel functions that can produce random numbers from various statistical distributions.

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Speaker: Dan O’Leary, President, Ombu Enterprises

Recorded on: May 14, 2020

Description: Regulatory expert Allison Fulton discusses best practices in complaint management. She covers:

• Evaluate trends in regulatory enforcement;
• The importance of consistent complaint intake in measuring effectiveness; and
• Auditing the complaint management system.

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Speaker: Allison Fulton, Partner, Sheppard Mullin

Recorded on: May 13, 2020

Description:Quality systems expert Christy Mazzarisi shares the latest methods for employing AI and robotics to quality management. She discusses:

• How new technology decreases costs and increases employee engagement;
• How intelligent automation increases quality and productivity;
• Applying continuous improvement methods; and
• Interpreting different methods and metrics used in continuous improvement projects.

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Speaker: Christy Mazzarisi, Quality Lead, CGI

Recorded on: May 7, 2020

Description: eQMS solutions expert Panos Boudovas discusses the potential for the ROI of quality. He covers:

• Calculating an ROI of quality, including operational efficiencies, time-to-market for new products, audit and qualification processes, access to documents and data as well as improvements in product quality;
• Building a business case for an eQMS by benchmarking your current quality performance; and
• Choosing the right eQMS solution that will be able to grow and scale to meet evolving business needs over time.

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Speaker: Panos Boudovas, CEO, Founder, ZenQMS