The Medical Device Development to Market Under Design Control

The Medical Device Development to Market Under Design Control

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$899

Date and time

Location

Online event

Refund policy

The Medical Device Development to Market Under Design Control.

About this event

Date: Aug11, 2022.

Time: 10:00:00 EST

Duration: 2 days - 8 total hours

Level: Intermediate to Advanced

Description

This session is scheduled for the 11th and 12th of Aug. The webinar will start from 10.00 am ET to 02.00 pm ET on both days.

The FDA expects companies to manage new product development projects formally -- to include regulatory requirements, design and/or change control, with consideration of all applicable standards. How can the FDA's Design Control requirements, 21 CFR 820.30, C8actually facilitate this? The EU MDR and their notified bodies are no different. How can this be done from a project's inception? How can a Project Leader or Project Manager ensure critical elements are not committed until late in the project when disaster looms? How to minimize scope creep? How to conclude a project "on time" and "within budget"? What are all the steps to get a product from conception to market, while adhering to the regulatory requirements in the US and EU? How to gain management support for the Milestones, Tasks, Timelines? Use the Plan as a powerful tool with FDA auditors. Use variations on these tools for any project, from the smallest to major company projects. Growing high-profile field problems indicate that much project management is poor or non-existant. Buy up-front time for proper project planning. These techniques are not rocket-science, but require the implementation of formal methods with documented, and defensible rationale. Use these tools to bring predictability to your company's product development process. Use them to defend your remediation efforts with the FDA. Use them to prove "progress against plan" with all stakeholders.

Areas Covered in the Session:

Day 1:

  • Design Control requirements (US and EU)
  • Meet Key Requirements of the CGMPs/ISO with Formal Project Mgmt.
  • The Three Most Common PM Tools - Gantt, CPM, PERT
  • Work Breakdown Structure, Reverse Engineering, Milestones, Tasks
  • Suggested Design Control Project Management Templates

Day 2:

  • The Device CGMPs
  • The 510(k) (FDA clearance) and PMA (FDA approval) and alternatives
  • EU MDR considerations
  • CE-marking

Who will benefit: The designations

This webinar will provide valuable assistance to all regulated companies that need a repeatable methodology, and their in-house personnel trained in project management tools and techniques targeted specifically to the regulated medical products industries, under cGMP and MDD/CE-marking compliance. It will discuss and provide examples of the most common project management tools and provide a major example for immediate use. This applies to companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.

The employees who will benefit include:

  • Senior management
  • Regulatory Affairs
  • Quality Assurance / QAE
  • Production
  • R&D and Engineering
  • All personnel tasked with any project management and new product development, and those who soon hope to be

Target Companies: (Examples)

  • Pfizer, Abbott, Hospira, J&J, Cardinal, Integra, GlaxoSmithKline, Merck & Co., Bayer etc….
  • Target Association:
  • RAPS, ASQ, et al

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