Q1 Productions Webinars
Please explore our upcoming webinars, as well as our archived webinars which are available for complimentary download
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
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
Underwriters Laboratories: Healthcare Packaging and Testing to ISO 11607-1 and -2
1 Hour Video | Marcus Corzilius, Underwriters Laboratories
Decision Criteria: New FDA Guidance Impacting the Requirement for 510(K) Clearance of Modified Devices
1 Hour Video | Kelliann Payne, Hogan Lovells
Unannounced Audit Case Study: A Medical Device Manufacturers Experiences
1 Hour Video | Patricia Schnoor, Capillus
Tools and Techniques to Ensure Successful Outcomes in Device GCP Audits
1 Hour Video | Becki Nowatzke, Wenzel Spine, Inc.
Implementing New Responsibilities for Economic Operators under the EU MDR
1 Hour Video | Erik Vollebregt, Axon Lawyers
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
Best Practices for Medical Device Human Factors Post-Market Surveillance Activities
1 Hour Video | Tressa Daniels, Becton Dickinson
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
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Chicago, IL 60603
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