Human Factors and Design Controls for Medical Devices and Combination Products: 2-day In-person Seminar

By: Bart Chapman MD MBA, President at OPD Consulting Group
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Course Description:

The course will give the participant the ability to formulate an QMS document and a thorough understanding of verification and validation procedures, The course will also give through guidance in development of Combination products both for the USA and European marketplace from a regulatory and manufacturing point of view. Emphasis will be placed on critical pathways, clinical development and regulatory approval.

Learning Objectives:

Upon completing this course participants should understand:

  • Office of Combination Products Update
  • The new draft guidance on CGMP requirements for combination products
  • Other recent and upcoming guidances and issues
  • The combination product development process
  • Clinical evidence development and coordination for combination products
  • Companion diagnostics regulations, guidances, and challenges
  • FDA assessment of combination product submissions
  • Industry assessment of FDA review of combination products
  • Aligning pharmaceutical CGMP and device Quality System Regulations
  • Quality by Design vs. Design Control
  • Risk management and combination products
  • Human factors and combination products – paradigm matching
  • Reconciling drug and device postmarket requirements and processes
  • Combination product inspections
  • Combination products in a global marketplace.

Who Will Benefit:

  • Drug, device, diagnostics, and biologics regulatory, quality, and clinical professionals involved with combination product development and oversight
  • Product stewards
  • Business development executives involved in combination product strategic partnerships
  • R&D and product testing professionals
  • Combination product supply chain professionals

Course Outline

Day One (8:30 AM – 3:30 PM)
  • 8:30 – 9:00 AM: Registration
  • 9:00 AM: Session Start Time
  • Combination Product Regulatory
    • Product profile, data, and performance
    • Metrics: mean approval times by product types or regulatory pathway
    • Recent and upcoming guidance documents
    • Are companies going to OCP for help with designations?
    • Making best use of OCP during the combination product life cycle
    • Jurisdiction of kits and other ambiguous products
    • Office of Planning report on FDA handling of combination products
  • The Combination Product Development Process
    • Evaluation of process improvement
    • IT assessment
    • Evaluation of industry performance
    • Key issues and deficiency
  • Quality by Design vs. Design Control
    • Compare and contrast the objectives and approaches
    • What is part of design validation?
    • Will CDRH and CDER accept the other’s approach?
    • Aligning the processes
  • Pharmaceutical CGMP and the Medical Device QSR
    • The GMP guidance document
    • Pharmaceutical CGMP
    • Purchasing controls in drugs vs. devices
    • The problem of retains and lot sizes
    • Panel discussion – How did you modify your quality system to accommodate combination products?
    • Pharmaceutical companies
    • Medical device companies
    • Managing internal documentation at each facility
    • Case studies
Day Two (8:30 AM – 3:30 PM)
  • Developing Clinical Evidence
    • Different drug and device clinical evidence requirements
    • Differing knowledge of mechanisms of action
    • Challenges of conducting device clinical studies
    • When is clinical evidence necessary, and what information should be collected (e.g. in bridging studies)
    • How do cGMPs / QSR apply during clinical studies?
    • Factors best addressed in simulated real use environment vs. controlled environment
    • Good Clinical Practices
  • Human Factors and Combination Products
    • FDA human factors guidance – status or report
    • Cultural differences – medication errors vs. engineering approaches
    • Case study – FDA review approach: roles and responsibilities of CDER vs. CDRH reviewers
    • Should non-significant risk human factor studies be submitted in the IND?
    • Value of or need for non-observational (real world use) usability testing
  • Risk Management and Combination Products
    • Reconciling drug and device approaches
    • The risk of the whole vs. the risk of the parts
  • Companion Diagnostics Regulations and Process
    • What is a companion diagnostic?
    • What are the challenges with companion diagnostics?
    • How do the proposed changes to FDA’s stance on LDT regulation affect companion diagnostics?
  • The Global Landscape of Combination Products
    • Definitions and Regulatory Pathways
    • Challenges

Meet Your Instructor

Bart Chapman MD MBA
President at OPD Consulting Group

As a board certified physician with over 30 successful years in the biopharmaceutical and medical device industry Bart Chapman MD MBA has been involved in approved NDAs, BLAs and PMAs and directing clinical trials through all phases.

His role has varied from developing Phase I-IV protocols and implementing them to overseeing strategic marketing and regulatory compliance. He has been involved in designing and implementing MOPS which have included integrating protocol design and phase I- IV implementation with the launch and marketing of approved products.

Dr. Chapman has secured sophisticated SABs as well as participated in numerous leadership roles as both physician investigator as well as physician advisor for the development of ocular, infectious disease, diabetes, oncology and medical device therapeutics. As a medical director and regulatory consultant, he has been responsible for the following:

  • Developing g strategies for identifying product safety concerns
  • Protocol development
  • Optimizing clinical efficiency using adaptive research methods
  • Meeting FDA and EU regulatory guidelines for NDA, PMA, BLA approvals
  • Safety labeling changes
  • Standardized AE/SAE formats/AERS
  • Impact assessments
  • Communication strategies regarding safety
  • Communications and responses to regulatory authorities
  • Mitigation strategies
  • Phase I-IV safety issues
  • Orphan drug and medical device regulatory requirements

As both an employee as well as a consultant to numerous pharmaceutical companies from Fortune 100 companies to small biotech companies, Dr. Chapman has a successful track record in developing strategic plans. In the process he has designed and implement GLP and GMP facilities.

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