Q1 Productions Webinars
Cognitive Human Factors for Medical Devices, Combination Products and Diagnostics
Wednesday, October 27, 2021 | 12:00 P.M. Central US Time | Russell J. Branaghan, PhD, President, Research Collective
Target Audience: Regulatory Affairs, Quality Assurance, Combination Products
Valuable Insights in the Journey towards Achieving IVDR Certification
Wednesday, November 3, 2021 | 9:30 a.m. Central US Time/4:30 p.m. Central EU Time | Carsten Krafcsik and Claudia Meneghisse, Tecan Switzerland
Target Audience: Regulatory Affairs, Clinical Research, Performance Evaluation, Quality Assurance, Research & Development
Packaging Materials Considerations for Healthcare Products
Tuesday, November 9, 2021 | 10:00 a.m., Central US Time | Betty Howard
Senior Radiation Sterilization Manager, Applied Sterilization Technologies,
STERIS
Target Audience: Packaging Engineers, Material Management, Sterilization, Biocompatibility
EO Sterilization: Considerations for Neonate Products and Medical Devices & ISO 10993-7
Wednesday, November 10, 2021 | 9:00 a.m. Central US Time | Grégory Grams, EO Technical Director & Marie-Pierre Hildebrand, RA/QA Director, EMEAA
Target Audience: Sterilization, Biocompatibility
Ensuring Compliance for your IVD’s Performance Evaluation
Tuesday, November 16, 2021 | 9:00 a.m. Central US Time/4:00 p.m. Central EU Time | Joseph-Richardson Larbi, Medical Device Regulatory Consultant, Celegence
Target Audience: Regulatory Affairs, Clinical Research, Performance Evaluation, Compliance
The Secret to Collecting Health Economics Data in Clinical Trials
Thursday, November 18, 2021 | 12:00 p.m. Central US Time | Melissa Martinson, MS PhD, Technomics Research, LLC
Target Audience: Health Economics, Outcomes Research, Value Analysis
Practical Insight into an IVDR QMS Audit: Preparation, Conduct & Outcomes
Tuesday, November 30, 2021 | 9:30 a.m. Central US Time/4:30 p.m. Central EU Time | Ioannis Bekatoros, Tosoh Bioscience
Target Audience: Regulatory, Clinical, Performance Evaluation, Quality Assurance, IVDR
Insight into the EMA CDx Review Pilot Program for IVDR Certification
Recorded on October 6, 2021 | James Hewitt, SIVD Product Expert, TUV SUD
Target Audience: Combination Products, Regulatory Affairs, Clinical Research, Performance Evaluation, Quality Assurance
Consolidating All Your Labels in a Single Label System
Recorded on October 6, 2021 | Chris Heckert, NETWORK PARTNERS
Target Audience: Labeling, Regulatory Affairs
Gaining the Edge with AI: Why AI is needed in Pricing & Selling, then Expanding on how to Apply Change Management to Maximize the Results
Recorded on September 9, 2021 | Jon Moeller, Senior Strategic Consultant, William Dudziak, Lead Strategic Consusltant, PROS
Target Audience: Pricing & Contracts, Pricing Strategy, Strategic Pricing Analyst, Manager, National Accounts, Corporate Accounts Manager
Optimal Patient Outcomes Begin with Better Data
Recorded on September 1, 2021
Target Audience: Product Development, Director of Product Management, Market Development Manager, Business Development, Sales Director, Territory Manager
Secure and Compliant Patient Data Management through Tokenization
Recorded on August 17, 2021 | Emily Mortimer, LexisNexis Risk Solutions Group
Target Audience: Product Management, Research & Development, Clinical Research, Data Management Medical Information, Patient Advocacy
Are Your Medical Communications in Need of Critical Care? Innovative Treatments for Healthier HCP Engagement
Recorded on August 3, 2021 | Lee Hopwood, Nicole Parker (PhD, ELS, CMPP), Rajni Parthasarathy (PhD, CMPP) Stephen Towers (PhD), HCG
Target Audience: Medical Affairs, Medical Science Liaison
The Ins and Outs of Post Market Surveillance Under the EU MDR
Recorded on July 13, 2021 | Joseph-Richardson Larbi, Celegence
Target Audience: Regulatory Affairs, Post-Market Surveillance, Medical Device
Practical Dive into AI, Machine & Deep Learning Regulatory Requirements within the EU MDR & Methods for Compliance
Recorded on June 24, 2021 | Leo Hovestadt, Elekta
Target Audience: Regulatory Affairs, Clinical Affairs, Software Engineering
X-Ray New Technological Advancements
Recorded on June 17, 2021 | Jeremy Brison, IBA Industrial
Target Audience: Sterilization, Sterility Assurance, Microbiology, Quality, Manufacturing
Unlock the Power of Advertising Claims Management – Using Claims as an Innovation Driver in the Food and Beverage Industry
Recorded on June 16, 2021 | John Cooper, Veeva Systems
Target Audience: Label Claims, Regulatory Labeling, Regulatory Affairs
Examining Material Performance for Accelerator Based Modalities
Recorded on June 8, 2021 | Leo Fifield, Pacific Northwest National Laboratory | Rod Parker, Stryker Instruments
Target Audience: Sterilization, Sterility Assurance, Microbiology, Quality, Manufacturing
Optimizing Timelines for Diagnostic & CDx Payer Outreach & Launch
Recorded on June 3, 2021 | Dana Dilbeck, Agilent Technologies, Inc.
Target Audience: Reimbursement, Market Access, Payer Relations/Payer Policy
OPDP & FTC Enforcement Trends
Recorded on May 26, 2021 |Heather Bañuelos & Gillian Russell, King & Spalding
Target Audience: Advertising & Promotion Regulatory Affairs, Advertising & Promotional Review, Regulatory Affairs, Commercialization
Improving Visibility and Understanding of the Patient Advocacy Function
Recorded on May 19, 2021 | Chris Smith, Katie Burns & Lisa Savitt, SmithSolve
Target Audience: Patient Advocacy, Patient Relations, Patient Affairs, Patient Engagement
Fundamentals of Sustainable Ethylene Oxide Sterilization
Recorded on May 6, 2021 | Carrie Clark, STERIS AST and Labs, Americas
Target Audience: Sterilization, Sterility Assurance, Microbiology, Quality, Manufacturing
The Different X-ray Solutions
Recorded on May 5, 2021 | Frederic Dessy, IBA Industrial | Jeremy Brison, IBA Industrial
Target Audience: Sterilization, Sterility Assurance, Microbiology, Quality, Manufacturing
COVID-19 Opportunities and Risks for the Diagnostic Industry
Recorded on May 5, 2021 | Brenna Jenny, Sidley Austin LLP
Target Audience: Regulatory Affairs, Reimbursement, Market Access, Payer Relations/Payer Policy
Exploring the Status of Liquid Biopsy: Recent NGS Approvals & Future Outlook
Recorded on May 4, 2021 |Trish Brown, Illumina
Target Audience: Reimbursement, Market Access, Payer Relations/Payer Policy
Diversity and Inclusion: Perspectives from Advocacy Groups and Biopharmaceutical Companies
Recorded on May 4, 2021 | Tim Turnham, PhD, Voz Advisors
Target Audience: Patient Advocacy, Patient Relations, Patient Affairs, Patient Engagement
Case Study: Optimizing Timelines for Diagnostic Payer Outreach & Launch
Recorded on April 29, 2021 | Shaunna Kobilis, Adaptive Biotechnologies
Target Audience: Reimbursement, Market Access, Payer Relations/Payer Policy
How Much was that Band-Aid? Collecting Health Economic Data in Clinical Trials
Recorded on April 27, 2021 | Melissa Martinson, Technomics Research, LLC
Target Audience: Health Economics, Outcomes Research, Value Analysis
Combination Products: Seeking a Notified Body Opinion according to MDR Article 117
Recorded on April 21, 2021 | Joseph-Richardson Larbi, Celegence
Target Audience: Regulatory Affairs
Embrace the Unconventional – Ideas for an Impactful Virtual National Sales Meeting
Recorded on April 15, 2021 | Margaret Piekarski, Itamar Medical
Target Audience: Sales Training, Sales Learning & Development, Commercial Training, Commercial Learning & Development
The Evolution of Pharma Support in Patient Advocacy Since 2015
Recorded on April 13, 2021 | Matt Toresco, The Brooks Group & Associates
Target Audience: Patient Advocacy, Patient Relations, Patient Affairs, Patient Engagement
Safeguard your Medical Devices from Cyber Threats
Recorded on April 8, 2021 | Shane Keating, ICS
Target Audience: Human Factors, Product Managers, Engineering Directors
What X-ray Brings to You: X-ray vs Other Modalities & Comparison Case Study
Recorded on Thursday, March 25, 2021 | Frederic Dessy & Frédéric Stichelbaut, IBA Industrial
Target Audience: Sterilization, Sterility Assurance, Microbiology, Quality, Manufacturing
Incorporating Secure Development Practices throughout the Total Device Lifecycle
Recorded on Tuesday, March 23, 2021 | 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
Project Experience with E-Beam: Case Study
Recorded on March 19, 2021 | Candice Nagel, IBA Industrial & Peter Baker, Quantum EBX
Target Audience: Sterilization, Sterility Assurance, Microbiology, Quality, Manufacturing
Navigating the Anatomy of Having Difficult Conversations Using Virtual Reality
Recorded on March 16, 2021 | Anna Strasshofer, MBA, Mursion | Paul Egan, Mursion
Target Audience: Sales Training & Education, Clinical Training, Professional Education, Medical Education
Opportunities for Real World Data in Diagnostics
Recorded on March 10, 2021 | Suzanne Belinson PhD, MPH, Tempus Labs Inc.
Target Audience: Reimbursement, Market Access, Payer Relations/Payer Policy
Post-Pandemic Sales Training for Life Sciences Professionals: How to Unlock Better Performance in Your Virtual Sales Force
Recorded on March 2, 2021 | Shelly King, CooperVision
Target Audience: Sales Training, Sales Learning & Development, Commercial Training, Commercial Learning & Development
Product Qualification in E-beam and X-ray – Part 2
Recorded on Tuesday, February 16, 2021| Florent Kuntz, Aerial & François Vander Stappen, IBA Industrial
Target Audience: Sterilization, Sterility Assurance, Microbiology, Quality, Manufacturing
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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