DACAR ENTERPRISES
DaCar will provide dynamic project oversight, task management and resource optimization so that individual contributors and teams complete tasks efficiently and effectively to meet timeline expectations.
Project Task Identification and Management
Mapping, Planning and Timeline Management
Tracking and Resource Optimization
Identify Critical Path Activities and Execute Contingencies
Metrics, Dashboard Generation
Daily/Weekly Management Communique
Gap assessments are performed and utilized by DaCar to create Quality Plans aimed at areas for improvement thereby elevating company SOP’s (standard operating procedures) to today’s quality demands. Insightful leadership will then provide guidance and authorship to implement and integrate all aspects of regulations and standards to these SOP’s.
Risk Management
EN ISO 14971:2012, ISO 13485:2016
Design Controls
21 CFR 820.30, ISO 13485:2016
Design Change
21 CFR 820.30, 820.40, ISO 13485:2016
Complaint Handling and Coding
21 CFR 820.196, ISO 13485:2016
Nonconformance
21 CFR 820.90, ISO 13485:2016
CAPA
21 CFR 820.100, ISO 13485:2016
Transfer insights and knowledge on quality management systems using various training techniques sharing the fundamentals of standards, the application of standards as well as the how and why they satisfy the regulations.
One on One in Workplace
One on Many in Classroom/Conference Room
Engineers, Supervisors, Management
Classroom Lecture and Exercises
Training Assessment Testing
Whether company lingo is old school or radically new, when referring to tools and terms, they all aspire to the same set of rules. Get the job done right, get the job done quickly and get back to full production mode. Some of the tools and terms you’ll hear along the journey are many and diverse. Understanding tools and terms and being able to “Apply” them is crucial to a successful project.
DaCar is partnering with the Cognition Cockpit tool to offer a truly unique Quantitative Risk Management experience.
“Remediation” sometimes has an unpleasant ring to it. Regardless of its driving force, i.e., audit finding, 483 observation, warning letter or human performance initiative, when embraced as a necessity, it can lead you to prominence that delivers product sustainability and longevity. Remediation is about elevating your company’s quality processes by aligning to current regulations and standards to ensure continued success. If you aspire to the Quality demands of today’s regulators then let DaCar help you pilot your goals.
Gap Assessments to CFR’s and ISO Standards
Quality Plans for the Vision Forward
Project Plans to Dictate Cadence
Dashboards to Optimize Resource Allocation
Metrics and Leading Indicators to Assure End Goals
Training to Self-Reliance
(April 2015 – February 2017)
Industry Leading Urology and Pelvic Health Company as Risk Management Consultant and Project Manager – Architect, train and implement quantitative risk management process and manage resources and timelines for urology products’ Risk Management Files to support lifting FDA Warning Letter.
(November 2013 – July 2015)
Multi-billion dollar Medical Device and Pharmaceutical Company as Quality Engineer – Manage resources and timelines for combination products’ Design History File (DHF) and Risk Management File (RMF) Remediation compliant to 21CFR Part 4 – Combination Products. Project Lead of Quality Engineers (5), to perform DHF gap assessments, create design history…
(March 2011 – September 2013)
Global multi-million dollar In Vitro diagnostic Company in assays and assay instrument platforms as Global 3rd Party Risk Management Consultant – Train, mentor and implement risk management process compliant to ISO 14971 and modify Post-Market Notification process compliant to 21CFR Part 807 to support lifting FDA Warning Letter. (March 2011 –…
(November 2012 – September 2013)
Innovative In Vitro Diagnostic Start-up Company of as Risk Management Consultant – Architect and implement risk management process compliant to ISO 14971 for new technology and instrument platform (November 2012 – September 2013) Project Lead working with Quality Director to establish Risk Management process Manage Resources and Timelines Project Task…
As the owner/operator of DaCar Enterprises, I am an engineering consultant with over 30 years’ experience in regulated industries. Accumulating substantial knowledge and experience on the use and integration of Quality Management Systems, I work closely with medical device and pharmaceutical companies on related CFR’s and ISO standards to help meet their objectives. Regulatory Compliance of Design Controls and Risk Management are at the heart of my expertise.
In my early days it was all about inventing, creating and forging patents. Learning to innovate, bringing a thought to life, making a functioning prototype from an inkling of an idea is exhilarating. Documenting a product’s lifecycle is an absolute must to ensure the idea makes it across the finish line and becomes a safe, effective and useful medical product. See some of my patent — my beginning.