Q1 Productions Webinars
Please explore our upcoming webinars, as well as our archived webinars which are available for complimentary download
Navigating COVID-Impacted Supply Chains While Maintaining Product and Brand Integrity in Dietary Supplements
Tuesday, May 12, 2020 | Noon CST | Suzie Trigg, Hayes Boone
Target Audience: Regulatory Affairs, Regulatory & Quality, Regulatory & Labeling, Quality Assurance, General Counsel, Compliance
Solving the Challenge of Relying on Intermediate Endpoints to Establish the Clinical Utility of Diagnostic Tests: Case Studies
Thursday, May 14, 2020 | Noon CST | Mark D. Hiatt, Guardant Health
Target Audience: Diagnostic Reimbursement, Market Access, Payer Relations, Health Policy
Conduct of Clinical Investigations During the Disruption of the COVID-19 Pandemic
Monday, May 18, 2020 | 10 AM CST | 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
Case Study: Use of Artificial Intelligence to Filter through Regulatory Sources for Data
Tuesday, May 19, 2020 | 11AM CST | Vada Perkins, Bayer
Target Audience: Life Science Regulatory Intelligence, Strategy & Policy
Scientific Issues in the Regulatory Assessment of EO Cancer Risk
Thursday, May 21, 2020 | 10 AM CST | Joseph Haney, Texas Commission of Environmental Quality
Target Audience: Medical Device Sterilization, Microbiology, Quality, Manufacturing
Collaborating with Key Thought Leaders to Enhance MI Communications
Tuesday, May 26, 2020 | Noon CST | Erica Werts, Alimera Sciences
Target Audience: Pharmaceutical & Medical Device Medical Information, Affairs, Communications
USDA Bioengineered (BE) Food Disclosure: An Overview for Industry Professionals Across the Supply Chain
Wednesday, May 27, 2020 | Noon CST | Sam Jockel, Aston & Bird
Target Audience: Regulatory, Labeling, Legal Counsel, Compliance
The Evolution of Regulatory Standards to Address AI and Machine Learning Based Medical Devices
Thursday, May 28, 2020 | Noon CST | Dave Saunders, Galen Robotics
Target Audience: Product Management, Product Managers, Product Marketing, Program Management, Product Development
Updates to Good Clinical Practice Standard: ISO14155 version 2020
Tuesday, June 2, 2020 | 8 AM CST | Klaas Van’t Klooster, ISO TC194 WG4
Target Audience: Medical Device Clinical Research, Clinical Affairs, Clinical Operations, Post-Market Surveillance, Biostatistics, Clinical Quality Assurance
Regulatory Guidance & Oversight of the USDA BE Disclosure Standard
Wednesday, June 3, 2020 | Noon CST | Trevor Findley, USDA
Target Audience: Food & Beverage Labeling, Regulatory Affairs, Compliance, Science Policy
Drive Virtual Collaboration with Human Connection
Thursday, June 4, 2020 | Noon CST | Kelly Leonard, Second City Works
Target Audience: Compliance Training, Ethics & Compliance Monitoring, Culture & Communications
Regulatory Roundup: Update on Legislative, FDA Policy and Regulatory Trends Affecting Life Science Organizations
Tuesday, June 9, 2020 | Noon CST | Kimberly Belsky & Kendra Martello, Mallinckrodt Pharmaceuticals
Target Audience: Life Science Regulatory Intelligence, Strategy & Policy
Case Study: Submission Process of Promotional Materials Referencing More Than One Application (Grouped Submissions)
Wednesday, June 10, 2020 | Noon CST | Shannon Collins, Pfizer
Target Audience: Pharmaceutical and Medical Device Advertising & Promotion, Regulatory Affairs, Regulatory Advertising & Promotional Review, Regulatory Affairs Advertising, Promotion & Labling
Efficiently Expediting Software Updates while Continuously Ensuring Product Performance
Thursday, June 11, 2020 | Noon CST | Donna Carlson, Medtronic
Target Audience: Medical Device Software Engineer, Software Quality, Quality, Regulatory
Case Study: Shelf Life & Expiration Date Labeling for Food Products
Tuesday, June 16, 2020 | Noon CST | Ben Austro, World Finer Foods
Target Audience: Labeling, Regulatory Affairs, Regulatory Compliance, Regulatory Labeling, Nutrition Labeling, Science Policy & Labeling
Usability for Patients in Home Environments
Thursday, June 18, 2020 | Noon CST | Stephen Nelson, Medtronic & Yoko Sen, Sen Sound
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
Bolstering Usability Testing with Proactive Front-End Study Development
Thursday, June 24, 2020 | 1 PM CST | Bart Peterson, BD Medical
Target Audience: Medical Device Human Factors, Usability, Engineering, Product Development
Practical Considerations on the FDA CFL Guidance
Thursday, June 28, 2020 | Noon CST | Abraham Gitterman, Arnold & Porter
Target Audience: Regulatory Affairs, Advertising & Promotion, Promotional Regulatory Affairs, Advertising & Promotional Review, Regulatory Affairs Advertising, Promotion & Labeling, Regulatory Affairs – Commercialization
Food Labeling & Immune Support Claims in the Time of Coronavirus
Tuesday, July 14, 2020 | Noon CST | Veronica Colas, Hogan Lovells
Target Audience: Food & Beverage Regulatory, Labeling, Legal Counsel & Compliance
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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