An Overview of Design and Development Planning
Instructor:
Ellen Golds
Product ID: 700380
Training Level: Basic
- Duration: 60 Min
How are you meeting the FDA Design Control requirement for Design and Development Planning? Are you simply putting something down on paper to comply with 21CFR820.30 or are you creating plans that serve as useful tools throughout the design and development process?
In this beginner seminar, we will review the concept of Project Planning, its various elements, when in the process a plan is required, what is required to be included, and its benefits. The pivotal role of a well developed Project Schedule and Project Management will also be reviewed.
The seminar will identify and review the key planning documents, including team assignments, management and conduct of the project, project phases, regulatory requirements and scheduling.
During this seminar, we will complete a sample Development Plan that you can use as a guide for writing your own Development Plans
Areas Covered in the seminar:
- The purpose of design and development planning
- Project Objectives
- Identifying major issues and constraints
- Project Team and Responsibilities
- Management and conduct of a project
- Project Phases
- Regulatory requirements
- Scheduling (schedule, work breakdown structure, task lists)
Who Will Benefit:
- Quality Assurance managers and personnel
- R&D managers, program and project managers & engineers
- Regulatory Affairs personnel
- Quality system auditors
Ellen Golds, is the Vice President of Product Development and Project Management at AlvaMed LLC, an innovative medical device technology consulting firm. She has over 27 years of experience in the medical device industry in R&D, New Product Development, and Project Management for companies ranging from start-ups to Fortune 500 companies, and as a consultant.
Ellen has assembled and led development teams on a variety of projects including bioabsorbable implantable devices, stents & stent-grafts, renal therapy devices, minimally invasive surgical tools, disposable devices and cardiac implant devices. She has implemented development planning and project management techniques in all phases of development, from exploration to concept to manufacture transfer and post-market management. As a consultant, she has mentored client companies and team leaders to improve design control, project management and project planning systems and implementation.
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