Quality Planning Process and Procedure
Instructor:
Ronald Schoengold
Product ID: 700665
- Duration: 60 Min
Why Should You Attend:
Each manufacturer decides how to apply these regulatory guidelines in developing a plan that consistently delivers high quality products and services.Each manufacturer is expected to develop a quality plan that supports its quality policy. The quality planning process takes into account organizational requirements at all levels of management and defines how the requirements for quality will be met. The outputs of the process are specific quality practices, required resources, and work activities that relate to the design and manufacture of products or the delivery of services.
Areas Covered in the seminar:
- Define Quality Policy.
- Build Quality Plan.
- Develop measurable organizational objectives
- Achieve product realization
- Align with Quality Policy
- Quality Plan procedure and template.
- Quality Manual requirements.
- Quality management system.
- Responsibilities and authorities
- Planning
- Implementation and communication
- Improvements
- Affecting change
- Communicating quality achievements.
Who Will Benefit:
- Managers with Management Objectives (MBOs)
- Quality Managers
- Regulatory Affairs Managers
- Program Managers
- Project Managers
- Product Development Managers
- Research and Development Managers
Ron Schoengold, is a consultant to the biotechnology and medical device industry, offering quality solutions, and technical and business information on the commercialization and maintenance of products and services. He has been an active contributor to the industry for over 38 years and has developed commercially successful therapeutic, screening and diagnostic products for gastroenterology, infectious disease and point-of-care testing. Ron is an advisor and mentor for the Larta Institute which is supported by the National Institutes of Health (NIH) to assist companies awarded SBIR grants. Ron has published, presented or contributed to more than 16 scientific journal articles, co-authored a book chapter on point-of-care testing and holds 8 patents related to point-of-care diagnostics.
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