Combination Products
Consulting Services, LLC

Experienced Consulting for your end-to-end pre- and post-market combination product needs.

Our experts understand the interactions between medicinal products (drugs/ biological products) and medical devices and the associated regulatory expectations.

Pre- and Post-Market

Quality/Regulatory/R&D/
Lifecycle Management

Change Management

About image
Susan Neadle, MS, BS, FRAPS, FAAO is a recognized international Combination Products and Medical Device expert with over 30 years of industry experience.  Networked, published, highly active in numerous industry groups with links to teaching institutions, Susan brings deep knowledge and genuine passion for sharing that knowledge with others. Susan’s leadership, innovation, and best practices have been recognized with multiple awards, including Fellowship in the Regulatory Affairs Professional Society, the 2022 ISPE Joseph X. Philips Professional Achievement Award for significant contributions as an integrator of industry and regulators; the Johnson Medal, Johnson & Johnson’s highest honor for excellence in Research & Development; and as a Finalist in TOPRA’s 2021 Awards for Regulatory Affairs Excellence.  She is Principal Consultant and President of Combination Products Consulting Services LLC, applying her extensive leadership, technical skills, and experience to provide international quality & compliance, regulatory, executive advisory and design/process excellence consulting services, to the biopharma and medical device industries.

Among her many industry contributions, she serves as Chair of the ISPE Combination Products CoP, serves as lead author for Combination Products standards efforts in ASTM International and AAMI, is active in Combination Products Coalition, and serves on the AFDO/RAPS Combination Product Steering Committee. She serves as faculty at University of Maryland Baltimore County Campus College of Natural and Mathematical Sciences and at AAMI for Combination Products and Medical Device Quality System Curricula. She speaks frequently at public venues on wide-ranging combination products topics. Her FDA peer-reviewed book, “The Combination Products Handbook: A Practical Guide” is coming available for purchase through Taylor & Francis Group, CRC Press (ISBN 9781032291628).

Prior to consulting, Susan retired from Johnson & Johnson after a distinguished 26+ year-Johnson & Johnson-career. Throughout her career, including integral leadership roles in R&D, Quality Engineering & Risk Management, and Design-to-Value, and as Chair of J&J’s Design Council, spanning Biopharma, Medical Device and Consumer Health sectors, she consistently advanced world-class practices in customer-centric product & process design, development, and commercialization. She conceived of, and successfully led, implementation of Janssen's globally integrated business model to meet Combination Products regulations. She also served as front- and back-room lead for multiple combination products health authority inspections.

Susan also served as Amgen’s Head of Combination Products, Devices, Digital Health & IVD RA, where she advised on internal regulatory policy priorities, health authority engagement and submissions approaches through strategic engagement and mentoring of colleagues. She also led interactions with health authorities and served as a catalyst for external consortium deliverables and strategic direction.

Susan can be reached at sneadle@combinationprod.com.

www.routledge.com/9781032291628
1st Edition
The Combination Products Handbook:  
A Practical Guide for Combination Products and Other Combined Use Systems
Edited by Susan Neadle (c)2023.

Contributing Authors:
John Barlow Weiner (FDA Office of Combination Products); Susan Neadle (CP Consulting Services)(retired, Johnson & Johnson); Suzette Roan (Sanofi); Mike Wallenstein (Novartis); Rick Wedge (Pfizer); Ed Bills (Ed Bills Consulting); Shannon Hoste (Agilis); Stephanie Canfield (Agilis);
Bjorg Hunter (Novo Nordisk); Theresa Scheuble (Johnson & Johnson); Kim Trautman (MediCept); Meera Raghuram (Lubrizol); Fran DeGrazio (retired, West); Jennifer Riter (West); Daniel Bantz (retired, West); Manfred Maeder (Novartis); Stephanie Goebel (Beyond Conception GmbH); Viky Verna (Confinis); Cherry Marty (Confinis); Dhiraj Behl (PPD)
The Combination Products Handbook:  A Practical Guide image

CONSULTING

Comprehensive support for building Combination Product Quality Management Systems Hands-on GMP Consulting and quality and compliance services for the biopharmaceutical and medical device industries Training - Available as a standard certificate curriculum, or customized to your specific organization's needs Combination Products Regulatory Affairs Guidance Executive Advisory Guidance and Support Multigenerational planning/ roadmaps Culture Change Management Program Management Design & Process Excellence; Design Thinking Quality System Audits QMS Remediation Connections and communications with regulators

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Combination Products Consulting Services LLC
Training Overview:  

Combination products, i.e., those medical products comprised of more than one type of constituent part (e.g., “drug device combinations,” drug/device, biological product/device, drug/device/biological product) are of growing importance to the healthcare industry, particularly in light of the pronounced growth of biological products that are dependent upon medical devices for their safe and effective administration.

Combined use of different medical product types raises questions about potential interactions between the constituent parts, and potential impacts to safety, efficacy, usability, reliability, and performance. Regulators are recognizing the increased complexity associated with combination products, and as such, are implementing regulatory frameworks and applying increased scrutiny to combination products both pre- and post-market. This highly interactive training course delves into key aspects of combination product development and lifecycle management, and includes case studies throughout.

This comprehensive training course:
  • can be customized to meet your needs (e.g., (1) executive leadership condensed training, (2) overview training for those that need familiarity but not deep expertise, (3) comprehensive training for those directly responsible for combination products day-to-day, and (4) in-depth training in specific subject matter. Course length and content will be adjusted to suit your needs.
  • is offered virtually or in person.  (On-line learning options are under development, and may be made available for use within your organization.)  It can be delivered modularly to accommodate time zone differences.
  • includes drug/ biological product-led (medicinal product) and device-led combination products. The class covers primarily US and EU approaches, while also touching on requirements for other jurisdictions.
Please reach out to Susan Neadle at sneadle@combinationprod.com if you'd like to learn more.

Principle Learning Objectives:
  • Clearly define and identify what constitutes a combination product
  • Identify applicable regulations, guidance, and standards applicable
  • Review and address challenges associated with the combination product lifecycle
  • Ability to understand and apply the required combination product development elements
    • Understand and apply integrated risk management,
    • Integration of QbD and Design Controls, and application of Design Control elements
    • Understand and apply Human factors, and  use related risk analysis
    • Identify key control strategy considerations
  • Understand post market expectations and safety reporting
  • Combination Product Inspection Readiness

Key Topics:
  1. What is a combination product?
    • A global perspective.
    • Product designation
    • Borderline products
  2. Challenges:
    • Language
    • Integrated Processes
    • Culture and Organization
    • Supplier Collaboration
  3. Regulatory Frameworks, Challenges and Strategies:
    • US FDA:
      • 21 CFR Part 4 as a Foundation
      • "Streamlined Approach"
      • Low Risk Devices, Ophthalmological Products with device administrations systems
      • Drug-based quality system and Device-based quality system"
        • Device "Called-out Provisions,"
        • Drug "Called-out Provisions,
        • Biological Product Expectations
      • IND and NDA content
    • EU Focus:
      • EU MDR (2017/745) as a Foundation
        • Requirements for Combination Products: General Safety & Performance Requirements (GSPRs)
        • Roles and Responsibilities of Various Stakeholders
        • Initial Approval and Changes across the Product Lifecycle
      • Pre-market requirements for clinical data
      • Documentation requirements
      • Interaction with Expert Panel and Notified Bodies
  4. Combination Product Development: In depth view of the integrated development process, including :
    • Integration of Quality by Design and Design Controls
    • Deep dive into each element of design controls for combination products:
      • combination product risk management (integration of ICH Q9(R1) and ISO 14971:2019)
      • user needs /intended uses/ use environments,
      • clinical considerations
      • human factors task analysis, use related risk analysis (URRA), formative studies
      • design & development planning
      • design history file
      • design inputs,
      • design outputs,
      • analytical considerations,
      • stability considerations,
      • Essential Performance Requirements (EPRs),
      • reliability expectations,
      • design verification,
      • design reviews,
      • design validation, , including human factors summative studies
      • design transfer: including process validation
      • design changes
    • Supplier Quality Considerations
    • Remediation strategies
    • Platform Strategies
    • Bridging Strategies
    • Digital Health considerations
  5. Post Market Considerations:
    • Design Transfer
    • Post Market Change Management
    • Post Marketing Safety Surveillance & Reporting
  6. Combination Product Inspection Readiness:
    • FDA's Combination Products Compliance Program,
    • Drug-PMOA
    • Device PMOA
    • Biological Product PMOA
    • Inspection Lessons Learned and Best Practices

Who Should Attend?:
Individuals accountable and/or responsible for R&D Project Management, Product & Process Development Scientists and Engineers, Regulatory Affairs, Quality, Clinical Affairs, Manufacturing, Post Marketing Safety Reporting

Pre-course Work Materials
Interactive Exercises
Learning Assessments
Certificate issued upon course completion.
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