Q1 Productions Webinars

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

Upcoming Webinars:

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

Wednesday, April 22, 2020 | Noon CST | Julie Tibbets, Goodwin Procter LLP

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

Navigating the Proposed Regulatory Framework for SaMD

Tuesday, April 28, 2020 | Noon CST | Yarmela Pavlovic, Manatt, Phelps & Phillips LLP

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

Mitigating Cybersecurity Concerns and Improving Software Safety

Thursday, April 30, 2020 | Noon CST | Steve Abrahamson, GE Healthcare

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

Masterclass: Leverage of Data Analytics for Strategic Portfolio Decision Making

Tuesday, May 5, 2020 | 11AM CST | Matthew Kokkonen, CSL Behring

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

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

Wednesday, May 6, 2020 | Noon CST | Kathy Sisson, Good Foods Group

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

Implementing the Medical Device Single Audit Program for IVD Organization

Thursday, May 7, 2020 | 11AM CST | Hilary Baldwin, Caris Life Sciences

Target Audience: Diagnostic Regulatory Affairs, Clinical Affairs

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

Thursday, May 14, 2020 | Noon CST | Mark D. Hiatt, Guardant Health

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

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

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

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

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

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

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

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

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