This document provides a summary of an individual's experience working as a control process engineer and quality engineer. It outlines their educational background which includes a bachelor's degree in industrial engineering and various Lean Six Sigma and quality systems certifications. It also lists their professional experience over 10 years working in roles such as a quality engineer, process engineer, and senior quality engineer for various manufacturing companies where they implemented quality systems and process improvement tools to increase efficiency.
Risk assessment for computer system validationBangaluru
A risk assessment is a process to identify potential hazards and analyze what could happen if a hazard occurs.
Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements.
Risk assessment for computer system validationBangaluru
A risk assessment is a process to identify potential hazards and analyze what could happen if a hazard occurs.
Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements.
The New Face of Quality in Office and Service EnvironmentsTKMG, Inc.
To subscribe: http://www.ksmartin.com/subscribe
To learn about Karen's books and products, please visit: http://www.ksmartin.com/books-products/.
This is a presentation I gave at the American Society for Quality World Conference on Quality and Improvement in St. Louis, MO in May 2010.
the various categories of qualifications necessary for Validating an equipment or instrument before & after installation. Those are
DQ(Design Qualification)
IQ(Installation Qualification)
OQ(Operation Qualification)
PQ(Performance Qualification)
Analytical Instrument Qualification and System ValidationComplianceOnline
Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory are records are on target of inspectors. The large number of warning letters issued to laboratories also demonstrate that they struggle with either understanding or implementing the regulations.
This 2-day course provides the regulatory background and guides attendees through the complete equipment qualification, calibration and computer system validation processes from planning to reporting. It also helps to fully understand Part 11 and Annex 11 requirements to ensure and document integrity and other requirements for electronic records and signatures.
The course not only ensures a full understanding of the regulations and guidelines for equipment and records but also provides templates and examples to develop inspection ready documentation. Interactive exercises will be dispersed into and between the presentations. About 50% of the total time will be dedicated to practical sessions. Here attendees work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned in the course.
For More Info:
http://www.complianceonline.com/analytical-instrument-qualification-and-system-validation-seminar-training-80113SEM-prdsm?channel=slideshare
Infodream Articles about Continuous Improvement, Aerospace, Quality Control a...Infodream
Articles include: 1. Lack of Training to Blame for Slow Up-take of Continuous Improvement Tools in Aerospace -- 2. SPC Vision Reduces Inspection Stages and Empowers Operators at Turbomeca UK -- 3. Real time SPC & Quality Control at Mölnlycke Health Care supports FDA’s PAT
In this slide contains Introduction, overview and details of FACTORY ACCEPTANCE TEST
Presented by: P.NARESH (Department of pharmaceutical analysis).RIPER, anantapur
21 cfr part 820 quality system regulation applying principles of lean docume...Compliance Trainings
In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to following 21 CFR Part 820, yet is based on solid principles and proven practices.
Get trained on practical aspects of FDA process validation, equipment qualification, Data analysis, statistical tools for Process Quality Management, more.
The New Face of Quality in Office and Service EnvironmentsTKMG, Inc.
To subscribe: http://www.ksmartin.com/subscribe
To learn about Karen's books and products, please visit: http://www.ksmartin.com/books-products/.
This is a presentation I gave at the American Society for Quality World Conference on Quality and Improvement in St. Louis, MO in May 2010.
the various categories of qualifications necessary for Validating an equipment or instrument before & after installation. Those are
DQ(Design Qualification)
IQ(Installation Qualification)
OQ(Operation Qualification)
PQ(Performance Qualification)
Analytical Instrument Qualification and System ValidationComplianceOnline
Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory are records are on target of inspectors. The large number of warning letters issued to laboratories also demonstrate that they struggle with either understanding or implementing the regulations.
This 2-day course provides the regulatory background and guides attendees through the complete equipment qualification, calibration and computer system validation processes from planning to reporting. It also helps to fully understand Part 11 and Annex 11 requirements to ensure and document integrity and other requirements for electronic records and signatures.
The course not only ensures a full understanding of the regulations and guidelines for equipment and records but also provides templates and examples to develop inspection ready documentation. Interactive exercises will be dispersed into and between the presentations. About 50% of the total time will be dedicated to practical sessions. Here attendees work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned in the course.
For More Info:
http://www.complianceonline.com/analytical-instrument-qualification-and-system-validation-seminar-training-80113SEM-prdsm?channel=slideshare
Infodream Articles about Continuous Improvement, Aerospace, Quality Control a...Infodream
Articles include: 1. Lack of Training to Blame for Slow Up-take of Continuous Improvement Tools in Aerospace -- 2. SPC Vision Reduces Inspection Stages and Empowers Operators at Turbomeca UK -- 3. Real time SPC & Quality Control at Mölnlycke Health Care supports FDA’s PAT
In this slide contains Introduction, overview and details of FACTORY ACCEPTANCE TEST
Presented by: P.NARESH (Department of pharmaceutical analysis).RIPER, anantapur
21 cfr part 820 quality system regulation applying principles of lean docume...Compliance Trainings
In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to following 21 CFR Part 820, yet is based on solid principles and proven practices.
Get trained on practical aspects of FDA process validation, equipment qualification, Data analysis, statistical tools for Process Quality Management, more.
Looking forward to a job where, thought smart worker, innovative work environment and knowledge of management skills, I can contribute meaningfully to the objective of my company. The job should provide a chance for higher responsibilities through self development. Improving Quality / Serviceability / Reliability at Telecom setup,
Embracing GenAI - A Strategic ImperativePeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Safalta Digital marketing institute in Noida, provide complete applications that encompass a huge range of virtual advertising and marketing additives, which includes search engine optimization, virtual communication advertising, pay-per-click on marketing, content material advertising, internet analytics, and greater. These university courses are designed for students who possess a comprehensive understanding of virtual marketing strategies and attributes.Safalta Digital Marketing Institute in Noida is a first choice for young individuals or students who are looking to start their careers in the field of digital advertising. The institute gives specialized courses designed and certification.
for beginners, providing thorough training in areas such as SEO, digital communication marketing, and PPC training in Noida. After finishing the program, students receive the certifications recognised by top different universitie, setting a strong foundation for a successful career in digital marketing.
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
Exploiting Artificial Intelligence for Empowering Researchers and Faculty, In...Dr. Vinod Kumar Kanvaria
Exploiting Artificial Intelligence for Empowering Researchers and Faculty,
International FDP on Fundamentals of Research in Social Sciences
at Integral University, Lucknow, 06.06.2024
By Dr. Vinod Kumar Kanvaria
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
1. Experience
Experience: Control Process
Engineer 4 years’
experience
Skills / Aptitudes
Processes
Skills: Design & Control Processes across Lean & Six Sigma Tools
Archievements: Standardize operations across work instructions and
operational training.
Increase the volumen of pieces across line balancing.
Reduce the thickness sealed variability through Anova&DOE,
having a process with a CPk of 1.33 four sigmas.
Implementation of TPM & SMED in sealers machines.
Monthly production record in the bags manufacturing
(1’000,000).
Costs Reduction (Materials-Labor)
Quality
Skills: Control Processes
Archievements: Yield reduction in the lines production across implementation
of control charts np- p
Education & Professional Qualifications
2000-2004 Bachelor’s Degree in Industrial Engineer
University of Guadalajara
Specialty in Quality Systems and Production
2008-201o Internal Course in Lean Manufacturing & Six Sigma
Lean Six Sigma Institute
Black Belt Certification
2010 External Course in Fundamentals of Injection
Careintra
2014 External Course AAMI (Association for the Advancement of Medical
Instrumentation) Quality System Regulation (21 CFR Part 820 “Legal
Requirement for manufacturers distributing medical devices in U.S.”)
2015 External Course ISO 13485:2012
Medical Devices
Industrial Engineering/Lean Manufacturing & Six Sigma
Gonzalo Alejandro Madrigal Gómez
San Juan Diego #36
45420, Tonalá, Jal. México
(55) (33) 36900551 Telephone
• (044)(33) 35978972 Cell Phone
@ amadrigal80@hotmail.com
Being an agent of change within the company, applying effective
leadership and teamwork to achieve continuous improvement in
processes to reach a common purpose for the growth of the company
Attributes
Discipline
Compromise
Responsability
2. Language
Native Language: Spanish
English: Level 80-90 %
At Proulex
Software
Microsoft Office. Advanced
JMP & Minitab. Advanced.
Others data
Profesional License. 5230095
Military ID. C- 3222342
2007-2010 PYMPSA Plastics & Raw Materials S.A.
Position: Quality & Control Process Engineer
Functions: In charge of the production lines of tube, film & lay flat extrusion, injection, sealing, assembly and
packing
Review of productivity indicators OEE
Daily, Weekly and Monthly fulfillment program
Line Balancing
Improvement and maintenance of Lay out.
Process Automation
Flow Process (Spaghetti Diagram)
Statistical process validation (IQ, OQ, PQ)
Product Released (Product in process & Finish product)
Non-conformance product in raw material, product in process and finish product
Process control for the output variable thickness in the bag Cpk.
Management of NOM 059, ISO 9001, FEUM.
Tools Lean Manufacturing.
OEE, 5´s, Andon, VSM, SMED, Celular manufacturing, TPM, 8’D, CTQ, AMEF, Control Plan.
Tools Six Sigma.
R&R, Control charts, Normality Test, CPk, ANOVA test, DOE, DMAIC
Chief: Eng. Moisés Linares Telephone. 36685959
2006-2007 EPT Emerson Power Transmission
Position: Planner Scheduler
Functions: Report and monitor production schedules
Product shipment tracking (by air-by ground)
Released of program to the supervisors
Monitoring products in Stockout, OEM & Backlog
Expedite product with the CSR
Review the shorcuts of materials
Review the demand & Forecast of the products to released daily program
Chief: Eng. Víctor Corona Telephone. 36880024 Ext. 216
Gonzalo Alejandro Madrigal Gómez 10 years of experience
Professional Experience
2016 JABIL ADVANCE MECHANICAL SOLUTIONS (Current)
Position: Sr. Quality Engineer
Functions:
Release product in process & Finished Good
NPI
FMEA, QCP
PPAP
APQP
CARs (8Ds)
2012 – 2016 FRESENIUS MEDICAL CARE
Position: Sr. Quality Engineer & Statistician
Functions:
Management in NOM 059(GMP), 21CFR210 & 820, ISO 13485
Management Review Administrator
Control Charts Implementation for the lines Liquid Acid, PD, Saline Solution & Sodium Citrate
Trending Analysis in all areas of the plant
Readiness and reception for FDA & COFEPRIS Audits
Establishes, maintains, and directly manages Statistical Techniques and Monitoring of Quality Data
programs. This includes but is not limited to statistical methods, sources of quality data, analysis tools to
comply with regulatory requirements and improve business performance.
Collaborates across all functions to identify emerging trends in quality data using both statistical and non-
statistical tools.
Establishes necessary processes that determine the most appropriate sources of quality data to be
monitored. Ensures the most relevant data is available to site management for assessments.
Contributes to investigations for threshold excursions and general problem solving associated with data
monitoring activities.
Evaluates and contributes to the implementation of risk techniques to determine escalation requirements
when quality issues and/or emerging trends are detected.
Provides statistical techniques support to functional groups in the organization as needed (design control,
validations, inspection, etc).
Processes large amounts of data for statistical modeling and graphic analysis using electronic software
tools
Assists in statistical software and spreadsheet validations related to the use of statistical techniques and
quality data monitoring.
Defines appropriate AQL’s and sampling plans used throughout the site, and ensure they are established
with the appropriate documented rationale.
Remains current on technical/technological advances and contemporary thinking in the Statistics/Data
Monitoring fields as they are applied to the medical device industry.
Establishes necessary training modules for and train personnel on the proper use and application of
statistical methods used at the site.
Provide assistance to lower level staff with general tasks that require a better understanding of functions, as
directed by immediate supervisor.
Reviews and complies with the Code of Business Conduct and all applicable company policies and
procedures, local, state and federal laws and regulations.
Professional Experience
2011-2012 IBM OF MEXICO
Position: QE Quality Engineer & Procurement Quality Engineer
Functions: Administrator of the Assembly-Packing Autoloaders line
Review and analyze the productivity indicators Yield (líne-suppplier)
Yield Reporting Inter-company (Gdl-San Jose)
Root Cause analysis for customer complaints (Hot line)
Management of ISO 9000 & 14000
Lean Manufacturing & Six Sigma
Improvements Continuous Team (Mudadori)
Field Return analysis
Control Charts Implementation for the Assembly line
Process audit tracing for ISO 9000 audits
Chief: Eng. Agustín Solís Telephone. 36697000
2010-2011 ZF SACHS
Position: Sr.Process Engineer
Functions: In charge of Welding, Assembly and packing line of shock absorbers
Review of productivity indicators OEE /TRS
Fabrication and maintenance of tooling
Line Balancing
Review the preventive maintenance in the machines
Monthly fulfillment of the goals
Find the window process in the machines (Parameters)
Elaboration of work instructions (HCO)
Process Control for the output variable Compression-Traction of the shock absorbers Process
Capability CPk
Implementation & tracing of the APQP
Process Validation PPAP
Management of TS 16949
Chief: Eng. Martin Castellanos Telephone. 32080000