Q1 Productions Webinars

Please explore our upcoming webinars, as well as our archived webinars which are available for complimentary download

Upcoming Webinars:

Opportunities for Real World Data in Diagnostics

Wednesday, March 10, 2021 | 10 am CST | Suzanne Belinson PhD, MPH, Tempus Labs Inc.

Target Audience: Reimbursement, Market Access, Payer Relations/Payer Policy

Navigating the Anatomy of Having Difficult Conversations Using Virtual Reality

Tuesday, March 16, 2021 | 12 pm CST | Anna Strasshofer, MBA, Mursion

Target Audience: Sales Training & Education, Clinical Training, Professional Education, Medical Education

Project Experience with E-Beam: Case Study

Friday, March 19, 2021 | 4PM GMT/ Noon US EST | Candice Nagel, IBA Industrial & Peter Baker, Quantum EBX

Target Audience: Sterilization, Sterility Assurance, Microbiology, Quality, Manufacturing

Incorporating Secure Development Practices throughout the Total Device Lifecycle

Tuesday, March 23, 2021 | 1 pm CST / 7 PM CET | Ken Hoyme, Boston Scientific | Tara Larson, Abbott | Steeve Huin, Irdeto

Target Audience: VP’s & Directors of: Cybersecurity, Product Management, Product Security, Product Cybersecurity, Global Information Security

What X-ray Brings to You: X-ray vs Other Modalities & Comparison Case Study

Thursday, March 25, 2021 | 5 p.m. CET/ 10 a.m. US CDT | Frederic Dessy & Frédéric Stichelbaut, IBA Industrial

Target Audience: Sterilization, Sterility Assurance, Microbiology, Quality, Manufacturing

Safeguard your Medical Devices from Cyber Threats

Thursday, April 8, 2021 | 11 am CST | Shane Keating, ICS

Target Audience: Human Factors, Product Managers, Engineering Directors

How Much was that Band-Aid? Collecting Health Economic Data in Clinical Trials

Tuesday, April 27, 2021 | 11 am CDT | Melissa Martinson, Technomics Research, LLC

Target Audience: Health Economics, Outcomes Research, Value Analysis

Webinars for Download:

How to Support Medical Equipment in the Post-Covid Era

Recorded on January 27, 2021 | Doug Stephen & Steve Petruk, CGS

Target Audience: Clinical Training & Education, Field Service, Professional Education, Medical Education

Extending the Reach & Effectiveness of Clinical Education with Distance Learning

Recorded on December 17, 2020 | Randy Straub, M.S.,R.T., CAE HEALTHCARE

Target Audience: Clinical Training & Education, Professional Education, Medical Education, Product Training, Surgical Education, Medical Affairs

Product Qualification in E-beam and X-ray – Part 1

Recorded on December 14, 2020 | Florent Kuntz & Nicolas Ludwig, Aerial & François Vander Stappen, IBA Industrial

Target Audience: Sterilization, Sterility Assurance, Microbiology, Quality, Manufacturing

EU MDR Impact to Drug Device Combinations and Device Classification

Recorded on December 9, 2020 | Jeremy Moore, AbbVie

Target Audience: EU MDR Regulatory, Global Regulatory Affairs, Regulatory Affairs, Combination Products

Considerations for IVD Involvement in the Emergency Use Authorization Pathway

Recorded on November 4, 2020 | Kelli Tanzella, Ph.D., Thermo Fisher Scientific

Target Audience: Regulatory Affairs, Clinical Affairs

Case Study: Conducting Monitoring Visits Remotely for IVD Clinical Trials During the COVID-19 Pandemic

Recorded on November 3, 2020 | Trish Landry, MBA, RAC, CCRP, BEAUFORT CRO | Leah Hollins, MPH, BA, BEAUFORT

Target Audience: Regulatory Affairs, Clinical Affairs

IVDR Compliance & Implications for IVDD Self-Tests

Recorded on October 8, 2020 | Erik Vollebregt, Axon Lawyers

Target Audience: Clinical, Regulatory

Medical Device Usability from a Clinically Embedded Perspective

Recorded on October 6, 2020 | Brittany Anderson-Montoya, PhD, Atrium Health

Target Audience: Human Factors, Usability/UX Testing, Design Assurance, Biomedical Engineering, System Engineering, Product Development

Overcoming Radiation Resistant Microbial Populations

Recorded on September 29 , 2020 | Betty Howard, STERIS Applied Sterilization Technologies

Target Audience: Sterilization, Sterility Assurance, Microbiology, Quality, Manufacturing

E-Beam Sterilization Basics – Conversion From Gamma to E-beam and System Description

Recorded on September 23, 2020 | Byron J. Lambert, Ph.D., ABBOTT | Cody Wilson, IBA

Target Audience: Sterilization, Sterility Assurance, Microbiology, Quality, Manufacturing

How to Start Preparing your RA/QA Team for the EUDAMED Database

Recorded on September 22, 2020 | John N. Bradsher, PhD, RAC, Celegence

Target Audience: Regulatory Affairs, Quality Assurance

Twice the Sales Call Time: Increasing Your Virtual Customer Engagement

Recorded on September 17, 2020 | Wendy Eicholzer, M.Ed., Whole Systems

Target Audience: Sales Training, Sales Learning & Development, Commercial Training, Commercial Learning & Development

Leveraging Dynamic Pricing, Contracting Agility and Digital Selling to Outperform the “Volatility Trifecta”: Fluctuating Demand, Costs and Competition

Recorded on September 15, 2020 | Craig Zawada, PROS | Jon Moeller, PROS

Target Audience: Pricing, Strategic Accounts, National Accounts, Contracting & Pricing, Corporate Accounts

What to Expect with Amendment 2 of IEC 60601-1 and Related Collaterals​

Recorded on August 11, 2020 | Pamela Gwynn, UL LLC

Target Audience: Regulatory Affairs, Compliance

How to Navigate the Marketing Landscape of Hemp-Derived CBD Foods and Dietary Supplements

Recorded on August 6, 2020 | Nathalie Bougenies, Harris Bricken

Target Audience: Regulatory, Labeling, Legal Counsel, Compliance

Adapting E-Commerce Strategies for Digitally Native Generations

Recorded on July 28, 2020 | Allie Shanholt, Do Anything Foods

Target Audience: Food & Beverage Manufacturers, E-Commerce/E-Commerce Sales E-Commerce Marketing, E-Commerce Supply Chain/Logistics/Operations, Omni-Channel Commerce, Direct to Consumer (D2C) Sales

UV Sterilization Trends in the Healthcare Clinical Setting

Recorded on July 15, 2020 | Pam Gwynn, UL; Deborah Jennings-Conner, UL Life & Health Sciences Division; Paul Evers, UL Life & Health Sciences Business Unit

Target Audience: Sterilization, Sterility Assurance, Microbiology, Quality, Manufacturing

Food Labeling & Immune Support Claims in the Time of Coronavirus

Recorded on July 14, 2020 | Veronica Colas, Hogan Lovells

Target Audience: Food & Beverage Regulatory, Labeling, Legal Counsel & Compliance

Practical Considerations on the FDA CFL Guidance

Recorded on June 28, 2020 | Abraham Gitterman, Arnold & Porter

Target Audience: Regulatory Affairs, Advertising & Promotion, Promotional Regulatory Affairs, Advertising & Promotional Review, Regulatory Affairs Advertising, Promotion & Labeling, Regulatory Affairs – Commercialization

Bolstering Usability Testing with Proactive Front-End Study Development

Recorded on June 24, 2020 | Bart Peterson, BD Medical

Target Audience: Medical Device Human Factors, Usability, Engineering, Product Development

Regulatory and Operational Considerations for Pediatric Formulation Development

Tuesday, June 23, 2020 | Noon CST | Daniel Petrillo, Taiho Oncology

Target Audience: Regulatory Affairs CMC, Global Regulatory Affairs CMC

Usability for Patients in Home Environments

Recorded on June 18, 2020 | Stephen Nelson, Medtronic & Yoko Sen, Sen Sound

Target Audience: Medical Device Human Factors, Usability, Engineering, Product Development

Case Study: Shelf Life & Expiration Date Labeling for Food Products

Recorded on June 16, 2020 | Ben Austro, World Finer Foods

Target Audience: Labeling, Regulatory Affairs, Regulatory Compliance, Regulatory Labeling, Nutrition Labeling, Science Policy & Labeling

Efficiently Expediting Software Updates while Continuously Ensuring Product Performance

Recorded on June 11, 2020 |  Donna Carlson, Medtronic

Target Audience: Medical Device Software Engineer, Software Quality, Quality, Regulatory

Case Study: Submission Process of Promotional Materials Referencing More Than One Application (Grouped Submissions)

Recorded on June 10, 2020 | Shannon Collins, Pfizer

Target Audience: Pharmaceutical and Medical Device Advertising & Promotion, Regulatory Affairs, Regulatory Advertising & Promotional Review, Regulatory Affairs Advertising, Promotion & Labeling

Regulatory Roundup: Update on Legislative, FDA Policy and Regulatory Trends Affecting Life Science Organizations

Recorded on June 9, 2020 | Kimberly Belsky & Kendra Martello, Mallinckrodt Pharmaceuticals

Target Audience: Life Science Regulatory Intelligence, Strategy & Policy

Drive Virtual Collaboration with Human Connection

Recorded on June 4, 2020 | Kelly Leonard, Second City Works

Target Audience: Compliance Training, Ethics & Compliance Monitoring, Culture & Communications

Regulatory Guidance & Oversight of the USDA BE Disclosure Standard

Recorded on June 3, 2020 | Trevor Findley, USDA

Target Audience: Food & Beverage Labeling, Regulatory Affairs, Compliance, Science Policy

Updates to Good Clinical Practice Standard: ISO14155 version 2020

Recorded on June 2, 2020 | Klaas Van’t Klooster, ISO TC194 WG4

Target Audience: Medical Device Clinical Research, Clinical Affairs, Clinical Operations, Post-Market Surveillance, Biostatistics, Clinical Quality Assurance

The Evolution of Regulatory Standards to Address AI and Machine Learning Based Medical Devices

Recorded on May 28, 2020 | Dave Saunders, Galen Robotics

Target Audience: Product Management, Product Managers, Product Marketing, Program Management, Product Development

USDA Bioengineered (BE) Food Disclosure: An Overview for Industry Professionals Across the Supply Chain

Recorded on May 27, 2020 | Sam Jockel, Aston & Bird

Target Audience: Regulatory, Labeling, Legal Counsel, Compliance

Collaborating with Key Thought Leaders to Enhance MI Communications

Recorded on May 26, 2020 | Erica Werts, Alimera Sciences

Target Audience: Pharmaceutical & Medical Device Medical Information, Affairs, Communications

Scientific Issues in the Regulatory Assessment of EO Cancer Risk

Recorded on May 21, 2020 | Joseph Haney, Texas Commission of Environmental Quality

Target Audience: Medical Device Sterilization, Microbiology, Quality, Manufacturing

Case Study: Use of Artificial Intelligence to Filter through Regulatory Sources for Data

Recorded on May 19, 2020 | Vada Perkins, Bayer

Target Audience: Life Science Regulatory Intelligence, Strategy & Policy

Conduct of Clinical Investigations During the Disruption of the COVID-19 Pandemic

Recorded on May 18, 2020 | Jack Capers, Jr., King & Spalding; Elisabeth Kohoutek, King & Spalding; Beverly Lorell, MD, King & Spalding, Chris Markus, King & Spalding; Geneviève Michaux, King & Spalding; Heather Sampson, University of Toronto

Target Audience: Medical Device Clinical Research, Clinical Affairs, Clinical Operations, Clinical Quality Assurance

Solving the Challenge of Relying on Intermediate Endpoints to Establish the Clinical Utility of Diagnostic Tests: Case Studies

Recorded on May 14, 2020 | Mark D. Hiatt, Guardant Health

Target Audience: Diagnostic Reimbursement, Market Access, Payer Relations, Health Policy

Navigating COVID-Impacted Supply Chains While Maintaining Product and Brand Integrity in Dietary Supplements

Recorded on May 12, 2020 | Suzie Trigg, Hayes Boone

Target Audience: Regulatory Affairs, Regulatory & Quality, Regulatory & Labeling, Quality Assurance, General Counsel, Compliance

Navigating the Regulatory Framework for SaMD

Recorded on May 11, 2020 | Yarmela Pavlovic, Manatt, Phelps & Phillips LLP

Target Audience: Medical Device Software Engineer, Software Quality, Quality, Regulatory

Implementing the Medical Device Single Audit Program for IVD Organization

Recorded on May 8, 2020 | Hilary Baldwin, Caris Life Sciences

Target Audience: Diagnostic Regulatory Affairs, Clinical Affairs

Case Study: Supply Chain Oversight & Communication to Establish Accurate Labels

Recorded on May 6, 2020 | Kathy Sisson, Good Foods Group

Target Audience: Food & Beverage Labeling, Regulatory Affairs, Compliance, Science Policy

Masterclass: Leverage of Data Analytics for Strategic Portfolio Decision Making

Recorded on May 5, 2020 | Matthew Kokkonen, CSL Behring

Target Audience: Pharmaceutical Portfolio Strategy, Optimization, Management & Launch

Mitigating Cybersecurity Concerns and Improving Software Safety

Recorded on April 30, 2020 | Steve Abrahamson, GE Healthcare

Target Audience: Medical Device Software Engineer, Software Quality, Quality, Regulatory

Drugs & Biologics – The Regulatory Landscape for Generic Drug and Biosimilar Production

Recorded on April 22, 2020 | Julie Tibbets, Goodwin Procter LLP

Target Audience: Pharmaceutical Promotional Regulatory Affairs, Legal, Medical Affairs

ISO 11737: Improving Bioburden Calculation Validity

45 Minute Video | Scott Weiss, Johnson & Johnson Sterility Assurance

Industry Case Study: Implementing an XML CMS in a Regulated Environment

45 Minute Video | Jennifer Sturr, Accuray, Inc.

Portfolio Management of Legacy Products

40 Minute Video |Angie Trujillo, Acell

Navigating Proposed Guidances Outlined in the Software Bill of Materials

45 Minute Video | Jim Jacobson, Siemens Healthineers

EU MDR Impact on Medical Device Labeling

40 Minute Video | Roger Peterson, Arthrex Inc.

Opportunities in ASC to Navigate the Future of Medical Device Reimbursement

1 Hour Video | Marilyn Denegre-Rumbin, Cardinal Health

Tools and Techniques to Ensure Successful Outcomes in Device GCP Audits

1 Hour Video | Becki Nowatzke, Wenzel Spine, Inc.

CMC Case Study: Best Practices in FDA Meeting Preparation Strategies

1 Hour Video | Stephanie Krogmeier, Vertex Pharmaceuticals

Reviewing OPDP Enforcement Actions and Best Practices for Compliant Drug Promotion

1 Hour Video | Linda Pollitz, Alkermes & Julie K. Tibbets, Goodwin Procter LLP

FDA Regulatory Due Diligence in Mergers and Acquisitions for Medical Device Companies

1 Hour Video | Pamela F. Forrest & Scott D. Danzis, Covington & Burling LLP

Portfolio Decision-Making – High Risk Versus Low Risk Strategies

1 Hour Video | Richard Bayney, University of Pennsylvania

Emerging Value-Based Commercial (VBC) Models in the Medical Device Industry

1 Hour Video | Harry Hangsheng Liu, RAND Corporation