Description
Finally, the presentation will touch upon the DFSS or Design for Six Sigma concepts and how they assist management in making decisions of whether the new product development is ready for prime time or is ready to be deployed in the field.

The principle of Six Sigma Blackbelt has begun to touch many different aspects of new product development and optimization of existing product. Whereas the paradigm of Six Sigma Blackbelt utilizes statistics, there are simplistic approaches that warrant further consideration by management. The paradigm needs to be implemented as a top-down effort and upper management should be the initial staunch supporter of the process excellence tools. This presentation will provide a primer of the Six Sigma Blackbelt concepts in a very easy to understand way. Specifically, attempt will be made to highlight the new product development process of DMADVV or Define, Measure, Analyze, Develop, Verify, & Validate.

The structured approach to problem-solving will also reference optimization of existing products by following the DMAIIC process or Define, Measure, Analyze, Innovative Improvement, and Control. Finally, the presentation will touch upon the DFSS or Design for Six Sigma concepts and how they assist management in making decisions of whether the new product development is ready for prime time or is ready to be deployed in the field.

Areas Covered in the seminar: * How do I approach new product development and not just focus upon the timeline but also in deploying the product that is easier to maintain once in the field. * How do I ascertain that I do not ignore important attributes? * How do I realize that I have gathered enough information or voice of the customer? * What are the potential pitfalls of not following the Six Sigma Blackbelt paradigm? * What are the defects per million opportunities or DPMO that are obtained if we follow the Six Sigma Blackbelt strategies? * How easy it is to be structured? * What is DFSS? How is it linked to the Six Sigma Blackbelt methodology? * What is the best way to ascertain the lowest maintenance cost of the product once in the field? Who will benefit: This webinar will provide a pragmatic approach to all regulated and non-regulated companies that need to assure that the changes made in the existing products alleviate the potential of the recalls and that the development of new product is cost-effective once deployed in the field. Maintenance is always an issue in the combination devices world which has aspects of drugs and devices in embedded devices which has aspects of hardware, software, and reagents. The employees of the Combination Devices, Medical Devices, Formulation, Diagnostics, Pharmaceutical, and Biologics fields who will benefit include: * Manufacturing personnel * R&D, QA, Manufacturing anagers and personnel * Statisticians * Operations Engineers * Consultants * Pre-production quality assurance personnel * Regulatory personnel preparing for 510(k) and PMA submissions * Regulatory personnel for NDA submission * Quality system auditors