MSEE
International Accreditation
Connect science, technologies, the most advanced engineering approach to infuse projects with novel ideas while outperformong the requirements to provide over the expectations.
Dan Craciun
North Carolina, USA
Engineering support and regulatory expertise within areas of quality management and quality assurance
Quality Systems implementation
Project management experience overlaping diversified engineering areas (automated systems, control systems, robotics, IT)
Equipment design and specifications, implementation, system integration
Commissioning, qualification, validation and process improvement
Emtacing Competence, Professionalism and Work ethics, the PATH to EXCELLENCE!
Professional Approach
Understand and envision patient needs…
Connect the science and the technologies using the most advanced engineering approach to enhance projects
Generate novel ideas to outperform requirements and provide over the expectations
KAIZEN
TOYOTA PRODUCTION SYSTEM (TPS)
JUST IN TIME (JIT)
AREAS OF EXPERTISE
Services
Quality Systems
● Implementation and Alignment
▪ Policies
▪ Procedures
▪ Protocols
Commissioning, Qualification, Validation
● Specification traceability
● FAT, SAT
● Protocol Authoring, Reports, Summaries
● SOP's, Handover
Quality
● Risk Management ● Compliance assessment
● Gap analysis and remediation ● Audit
● Policies, Procedures, Protocols
GxP
● CSV, Equipment, Utilities, BMS
● Electronic Documents, UID / GUDID
● Packaging Lines
● Filling Lines
● SIP/CIP
Engineering
● Performance and optimization
● Solution implementation
● Installation, integration, training, post-installation and manufacturing support
Curriculum
Education
Master of Science in Electrical Engineering - Milwaukee Council of International Education
MSEE
Industrial Automation, Communications
Master of Science in Electrical Engineering - Polytechnic Institute of Iasi Romania
BSEE
Industrial Automation
Bachelor of Science in Electrical Engineering - Polytechnic Institute of Iasi Romania
Continue Education
ROBOTICS
FANUC Robotics
IT
Software Development
HTML and CSS, W3Schools
IBM PC, mainframe, networking, data communication
WINDOWS, LINUX
STATISTICS
Acceptance Samplimg - Tylor
Engineering Statistics
Certifications and Training
COMPLIANCE
GMP & cGMP
GAMP 4 & GAMP 5
Commissioning and Qualification, ISPE
Risk-Based Commissioning & Qualification Benchmarking, ISPE
21 CFR Part 11 / ANNEX 11, Data Integrity
Software Validation
Process Validation
REGULATORY
FDA Regulations - Pharmaceutical and Medical Device
EudraLex - Computerized Systems
AUTOMATION
Allen Bradley – Rockwell Control Systems
Siemens Automation and Control Systems
B & R Automation
SAFphire & SBL Programming
SCADA
COGNEX Machine Vision
Systech
Maple Systems
SAFphire & SBL Programming
PROJECT MANAGEMENT
Portfolio
- All
- Engineering
- Design
- Quality
Blog
Road to success
Tower Hamlets or mass or members of propaganda bananas real estate. However, a large and a mourning, vel euismod.
Road to success
Tower Hamlets or mass or members of propaganda bananas real estate. However, a large and a mourning, vel euismod.
Contact
office@iubix.com
EmailResearch Triangle - Durham, North Carolina, USA
Addres(+1) 252 452 8660
PhoneCredits
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Ethics, Competence, Professionalism: the tools to build the PATH from QUALITY to EXCELLENCE!