UDI: What & How within the overall Medical Device value chain Webinar on Medical Device Regulation UDI
By Jim Petragnani

Webinar on Unique Device Identification (UDI): What & How within overall Medical Device Value Chain.

Planning and Implementation of the Medical Device Regulation (UDI)

Step 1. Developing the UDI compliance plan

  • Brief senior management on project scope and provide resource requirements with cost
  • Receive senior management project approval
  • Build the right team members who are dedicated and have the right complement of product/process knowledge
  • Define clear roles, accountabilities and responsibilities
  • Understand the requirements of the Medical Device Regulation
  • Engage in an approach that will confirm assumptions early and allow for joint agreed adjustment to the plan
  • Evaluate the supply chain business processes
  • Produce gap assessment and generate gap findings and conclusions
  • Prepare for innovative and sustainable change to the go-forward environment - monitor publications
  • Plan and provide that product experts enable knowledge transfer
  • Develop a plan for Change Management
Step 2. Understanding the Machine Readable Technology

  • That number on the medical device, It's not just a number....It means something
  • Standard product identifier
  • Reach out to the global community
  • Benefit to the medical community
  • Better traceability
  • Expedite recalls
Step 3. Change Management

  • Create compelling story or business case
  • Build a team who are fully committed to the change initiative
  • Create the vision
  • Communication, Communication, Communication
  • Start with "short term" wins
Step 4. Risk Assessment keeping the system agile for future changes

  • Proactively identify and manage risks
  • Assess Labeling changes - Global Packaging
  • Supply Chain continuity planning
Step 5. Implementation of UDI plan across the value chain

  • Review with project team key points of requirement
  • Identify the representative products for assessments
  • Build implementation road map, resourcing including cost
  • Identify low impact product device for implementation as pilot project
  • Present implementation recommendations and validate with stakeholders
  • Parallel process low impact product device
  • Evaluate and communicate results of "pilot" product
Step 6. Identifying the data sources for FDA reporting

  • Develop UDI data source map
  • Develop UDI database for FDA Reporting
  • Submit information to FDA which will be used to populate the Unique Device Identification Database (GUDID)
Speaker

Jim Petragnani

Jim developed multiple solutions and systems while directing the business development function at GS1, and implemented technology, standards and systems around framework similar to UDI, for various industries like Defense, Aviation including Medtech. He was also instrumental in consulting Industry members to assist FDA in developing the UDI framework and regulation. Jim Brings extensive experience and understanding on information technology and supply chain systems development and implementation.

Who should participate?

  • * Compliance Quality Assurance
  • * Risk Management professionals
  • * Regulatory affairs professionals
  • * Exe. Mgmt. Business Owners
  • * Labeling professionals
  • * Post Market professionals
  • * Safety professionals
  • * International BD professionals
  • * Medical Device Manufacturers.
Limited Participants:
Maximum 100 only
Contact

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