Development Planning: How to Structure, Write, and Effective
Instructor:
Richelle Helman
Product ID: 700190
Training Level: Basic
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.
What Attendees will Learn:
- 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 & engineers
- Regulatory Affairs personnel
- Quality system auditors
Richelle Helman is a senior consultant with AlvaMed, LLC, an innovative medical technology consulting firm. She is a key contributor to AlvaMed’s QA/RA and Design Control practice, having over 19 years of experience in the medical device industry.
Richelle has driven the implementation of an improved design control system in response to an FDA 483 within the project team and has developed and implemented other design control systems. Her diverse career has provided her with experience in all phases of a design (from concept through commercialization) from engineering, quality assurance, regulatory affairs and project management viewpoints in the areas of cardiology, urology, ophthalmology and artificial organs.
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