Q1 Productions Webinars

Upcoming 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

 

Webinars for Download:

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

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