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Q1 Productions Webinars

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

Upcoming Webinars:

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

Webinars for Download:

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

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

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