This training will identify and review the key planning documents, including team assignments, management and conduct of the project, project phases, and regulatory requirements and scheduling.
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.
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
Course Provider
Ellen Golds,
