Photo Banner Tutorials - MSC

Please see full course schedule for more information.


T01: ADVANCED MET/CAL PROGRAMMING WITH ANY STANDARD

FULL DAY COURSE: 

Monday, March 25th: 8:00am – 5:00pm

Speaker: Mike Schwartz, Cal Lab Solutions/Cal Lab Magazine/MSC

Abstract

ABSTRACT:

Using Fluke MET/CAL and advanced programming techniques, this tutorial will cover a standardized method for creating drivers for new hardware not natively supported by an instrument-specific Function Select Code (FSC). used to create an automated calibration.
We will cover how to create sub-procedures / sudo-drivers and call them from the main calibration procedure. Then calculate and include ISO\IEC 17025 compliant measurement uncertainties.
Students will get to create a sample procedure using the Meatest 9010+ calibrator and receive a set of free sample drivers they can use as a template for other standards in their lab.

Instructor Biography

Instructors:

MSC M Logo - Measurement Science ConferenceMr. Schwartz completed training at Lowry AFB in 1989 and was honorably discharged after 11 years of serving in the US Army. He graduated from the University of Maryland with a degree in Business Management and a minor in Computer Science. After leaving the military, he spent the first five years as Intercal’s the lead developer writing automation calibration software before starting his own company. Since 2003, as the principle owner of Cal Lab Solutions, he worked to developed the world’s largest library of MET/CAL® procedures as well as designed and developed a whole new metrology software platform, Metrology.NET®.  


T02: UNDERSTANDING INSTRUMENT SPECIFICATIONS

HALF DAY AM COURSE: 

Tuesday, March 26th: 8:00am – 12:00pm

Speaker: Michael Johnston

Abstract

ABSTRACT:

Instrument specifications play a crucial role in measurement and testing, but their lack of standardized definitions can often lead to confusion and uncertainty. In this tutorial, we will delve into the world of instrument specifications and explore the different ways in which manufacturers and other organizations define these statements.
By understanding and interpreting these specifications, participants will gain the knowledge and skills necessary to make meaningful metrological decisions. Using examples from a wide range of measurement disciplines, we will highlight the quirks and tricks of interpreting instrument specifications. Topics covered will include common terminologies, units, tolerances, accuracy, precision, resolution, and calibration. Practical strategies for evaluating specifications, comparing instruments, and selecting appropriate instruments for specific measurement tasks will also be discussed. 

Instructor Biography

Instructor: 

Michael Johnston | MSCMichael Johnston is the Software Portfolio Product Manager at Fluke. His extensive experience in calibration, metrology, measurement uncertainty and mathematical analysis was honed at Fluke, Northrop Grumman, SIMCO Electronics and the US Army. He holds a BS in Applied Mathematics from SUNY Empire State. 


T03: RISK MANAGEMENT AND QUALITY IMPROVEMENT METHODOLOGIES IN A LABORATORY – ACCREDITATION PERSPECTIVE

HALF DAY COURSE AM: 

Tuesday, March 26th: 8:00am – 12:00pm

Instructors: Prasanth Ramakrishnan, Prafulla Yelve, International Accreditation Service (IAS)

Abstract

ABSTRACT:

ISO/IEC 17025:2017, General requirements for the competence, impartiality, and consistent operation of laboratories, requires laboratories to employ a risk-based approach to identify and mitigate risks to laboratory activities, as well as to identify and implement opportunities for continuous improvement.  Both serve to increase confidence in the performance of a testing or calibration laboratory and in providing adequate technical information.   

Factors impacting the operations and competency of a laboratory from a two-dimensional perspective encompassing risk management and process improvement will be discussed during the session. 

This tutorial will provide the attendee with: 

  • Methodology for identification, monitoring and mitigating the risks 
  • Quality improvement methodologies and strategies 

Instructor Biography

Instructors: 

Prasanth S Ramakrishnan - MSCMr. Prasanth S Ramakrishnan is the Senior Manager working for International Accreditation Service (IAS). He is a Mechanical Engineer with a Masters’ in Mechanical and Industrial Engineering from Texas Tech University.  He is active member of technical organizations such as American Society of Quality (ASQ) and member of the Asia Pacific Accreditation Cooperation (APAC) proficiency testing committee. 

He has conducted numerous assessments and training sessions on conformity assessment standards for many testing and calibration laboratories to ISO/IEC 17025.  He also conducted many assessments across other conformity assessment standards. His expertise is focused on management systems, mechanical and geotechnical sectors. He has participated and presented in technical discussions, accreditation criteria meeting hearings, miscellaneous conferences and trade shows.  

Mr. Prafulla Yelve - MSCPraful Yelve is working as Technical Liaison- South Asia with IAS and he is responsible for engaging with customers by providing technical support and handling their queries to meet their expectations. Praful also conducts test and calibration laboratory assessment as a lead and technical assessor as per ISO/IEC 17025 and qualified assessor for ISO17020 and ISO17021-1 too. 

Praful was previously employed as the General Manager for Indian Conglomerate Godrej & Boyce Mfg Co. Ltd. and headed their Calibration & Inspection business for more than 15 years before joining IAS in year 2020. He is member of technical organizations such as Metrology Society of India (MSI) and NCSL International (NCSLI). He also conducts training/workshop related to laboratory activities such as ISO17025 Awareness, Internal Auditing, Measurement Uncertainty, Metrology and Calibration, Risk Assessment etc.  

Mr. Yelve’s academic background includes a Diploma in Mechanical Engineering with experience in Calibration, Testing, Inspection and additionally he has done several certification courses in calibration and testing domain. 


T04: HOW TO SELECT, IMPLEMENT, AND MAINTAIN CALIBRATION SOFTWARE SYSTEMS

FULL DAY COURSE: 

Tuesday, March 26th: 8:00am – 5:00pm

Instructor: Walter Nowocin, Indysoft Corporation

Abstract

ABSTRACT:

Selecting, Implementing, and Maintaining a Calibration Management Software System is a critical process for a calibration laboratory, especially in a regulated environment. However, there are few examples or documents that explain this process from a user’s perspective. The objective of this paper is to explain the selection process, the implementation process, and the maintaining process, while providing examples of the documentation used and to pass along lessons learned.

The following topics will be discussed: 

  • Selection Process Overview with a focus on how to “Develop Business Requirements”
  • Implementation Process Overview with a focus on the “System Development and Validation Life Cycle”
  • Maintaining Process Overview with a focus on “Configuration Management and Change Control.” 

Instructor Biography

Instructor: 

Walter Nowocin - MSCWalter Nowocin is the Life Sciences Product Manager for IndySoft Corporation. Walter works with development, marketing, and sales to ensure that IndySoft is optimized to support calibration quality systems in regulated industries while being compliant with FDA, GMP, and ISO requirements. Walter has over 35 years of calibration experience with Medtronic, the world’s largest medical device manufacturer, as a Calibration Department Senior Engineering Manager and with the United States Marine Corps as a Precision Measurement Equipment Laboratory Master Sergeant. Walter is Co-Chair of the NCSL International Healthcare Metrology Committee and is the Coordinator of the NCSLI Minnesota Section. Walter is the recipient of the 2023 NCSLI Education and Training Award and is a Co-Author of the Third Edition of the ASQ Metrology Handbook. Walter has a Masters in Engineering Management degree from St. Cloud State University, Minnesota and is a Fellow of the American Society of Engineering Management. 


T06: LIVING STANDARD – UNDERSTANDING ISO 6789-2:2017 REQUIREMENTS FOR THE CALIBRATION OF TORQUE WRENCHES

HALF DAY COURSE AM: 

Tuesday, March 26th: 8:00am – 12:00pm

Instructor: Peter Jäger

Abstract

ABSTRACT:

Since 2017, the basis for the calibration of torque wrenches has been ISO 6789:2017 . This standard requires the determination of b-parameters, which characterize the characteristics and parameters of torque wrenches.

What is behind these b-parameters, how great is the influence of geometric effects of the drive part, the fluctuation due to the adapter, the torque application point and the repeatability on the calibration result and the application in practice.

The seminar explains ISO 6798-2 and the influences can be experienced in practical exercises. 

Instructor Biography

Instructor: 

Peter Jäger - MSC

Peter Jäger: born in 1959 entered the world of professional metrology in 1981 with about 4 years of training as a calibration technician. Most of this training took place with the US Air Force in Denver, Colorado. From 1991, he was head of a mobile calibration laboratory; later he was head of a calibration laboratory for temperature for several years, achieving the accreditation. After a period as a project manager for calibration projects, which also included the creation of calibration procedures, he moved to the management of measuring and testing equipment for a large public authority. From there, he successfully completed his training as a DGQ quality manager and was then primarily responsible for the development, establishment and operation of an effective and standard-compliant quality management system. He currently works for a leading global metrology company as head of an accredited calibration laboratory and training manager for metrology seminars. 


T07: HOW DO I PLAN FOR PT/ILC AND THE RISK OF EVALUATION THEREOF?

FULL DAY COURSE: 

Wednesday, March 27th: 10:45am – 5:00pm

Instructor: Yvette Volschenk, ISO/IEC 17025 Consultant; ANAB Contract Lead Assessor; American Standard Calibration Laboratory – South Africa

Abstract

ABSTRACT:

How do I plan for PT/ILC? How do I perform a risk evaluation on my PT/ILC Plan? What is important about the ILC/Protocol and will the laboratory benefit from participating in the PT/ILC that is specified in the Protocol? How do I interpret the PT/ILC results and how does the outcome of the PT/ILC results add value to the laboratory? How do I perform Corrective actions on my PT/ILC results? 

If we read the requirements of ISO/IEC 17025: 2017 section 7.7.2 I quote The laboratory shall monitor its performance by comparison with results of other laboratories, where available and appropriate. This monitoring shall be planned and reviewed and shall include, but not be limited to, either or both of the following: 

  1. a) participation in proficiency testing;

NOTE ISO/IEC 17043 contains additional information on proficiency tests and proficiency testing providers. Proficiency testing providers that meet the requirements of ISO/IEC 17043 are considered to be competent. 

  1. b) participation in interlaboratory comparisons other than proficiency.”

 

When we participate in a PT/ILC, it is not just to comply with the requirements of ISO/IEC 17025:2017. It is to get value added from the PT/ILC results to ensure the laboratory performs the calibrations or tests correctly and that the calibration or test results can be repeated under the same circumstances by any laboratory calibrating the same artifact or test specimen.  

When a PT/ILC is planned, the predetermined criteria are very important. The predetermined criteria must be fit for what the laboratory is calibrating or testing. This includes the range and measurement uncertainty (where relevant), etc. The planned PT/ILC must be in line with the PT/ILC plan. It is not beneficial to the laboratory if the same type of PT/ILC is planned every year. The planned PT/ILC must take into consideration that the accredited scope is covered in the PT/ILC cycle and it can confirm the working range and CMC (where relevant) of the laboratory. 

When the outcome of the PT/ILC results is received back, are the laboratory’s results within the specified criteria? If not what now? Corrective action must be registered, and action must be taken immediately, otherwise, the laboratory risks reporting incorrect results to the customer. 

How do I interpret the PT/ILC results? How do I use the PT/ILC results to improve the activities in the laboratory? Just to determine if the En value is within 1 or the Z-score is within 2-sigma does not benefit the laboratory. The results must be analyzed and understood to be able to benefit the laboratory or to be used to improve the performance of the laboratory. By analyzing the results correctly, one can determine where there might be a risk in the system and process, or if the system and process is still fit for use. 

When evaluating the PT Plan, the risk associated must be determined. Which areas are high-risk, medium-risk, or low-risk areas? Which calibration or testing activities are performed daily or once a year? How do I determine the criteria for the high-risk, medium-risk, or low-risk areas? 

PT/ILC participation ensures the validity of the results reported to the customer and reduces the risk of reporting incorrect results to a customer. 

Instructor Biography

Instructors: 

Yvette Volschenk - MSC

I have ± 30 years of experience working in a calibration laboratory in various fields of calibration. One of the specialist fields is temperature, where I calibrated equipment’s such as Nobel and base metal thermocouples. Platinum resistance thermometers, digital and liquid-in-glass thermometers, ovens, furnaces, incubators, autoclaves, dry well calibrators etc. 

I am a consultant using my expertise in various international standards. As a consultant in ISO/IEC 17025:2017 I assisted laboratories in obtaining accreditation for calibration laboratories in various fields, testing laboratories in various fields and stack emission sampling laboratories. As a consultant for ISO/IEC 17020:2012 I assisted inspection bodies in obtaining accreditation in the field of occupational hygiene, textile, clothing, leather, and footwear and in the field of electrical inspections. 

I present training in the requirements of ISO/IEC 17025:2017 and ISO/IEC 17020:2012, Uncertainty of Measurement, Internal Auditing, and various technical fields. I have up to date presented these training courses customer specific. 

I used to be a SANAS contracted technical assessor in South Africa for temperature calibrations as well as force torque and harness, from 2005 until 2015, and was a member of the temperature special technical committee and the chairman of the force, torque, and hardness special technical committee. I was also in these fields part of work groups that compiles additional requirement documents for SANAS 

I am currently a contracted assessor for ANAB in various calibration fields and I am proud to be working as a contracted assessor for ANAB. 


T08: FUNDAMENTALS OF DECISION RULES AND CONFORMITY DECISIONS 

HALF DAY COURSE AM: 

Tuesday, March 26th: 8:00am – 12:00pm

Instructor: Jeff Gust

Abstract

ABSTRACT:

This tutorial teaches how to apply decision rules in order to comply with ISO/IEC 17025:2017 regarding statements of conformity (e.g. pass/fail, in-tolerance or out-of-tolerance).  The tutorial is appropriate for both beginners in this subject and people with high levels of expertise.  Many decision rules are covered along with their level of false accept and false reject risk.  Original reference papers are also provided along with examples and how to use different free software to make the analysis work easier. 

 Attendees are encouraged to bring laptop computers. 

Instructor Biography

Instructor: 

Jeff Gust - MSCJeff is the Chief Corporate Metrologist for Fluke.  Since joining in 2010, he has driven improvements in measurement quality for engineering, manufacturing and service activities for Fluke and Fortive organizations around the world.  He has been a key contributor to development of international standards and practices for calibration laboratories, and a writing group member for ISO 17025:2017, ISO 17043:2010 and ILAC P14-2020.  In 2011 Jeff was recognized by the Measurement Science Conference for outstanding contributions and leadership in metrology, and in 2017 was named a Fluke Fellow, the highest technical award for the company.  Prior to joining Fluke, Jeff has co-authored publications with NIST and served as a consultant to NIST and UNIDO.  Jeff has a bachelor’s degree from Purdue University in physics. 


T10: ISO/IEC 17025:2017 TESTING VS. CALIBRATION

HALF DAY COURSE PM: 

Tuesday, March 26th: 1:30pm – 5:00pm

Instructor: Emil Hazarian

Abstract

ABSTRACT:

ISO/IEC 17025:2017 stands as the global reference for ensuring the competence of testing and calibration laboratories. This presentation intends to analyze, compare, and elucidate the distinct characteristics, methodologies, and compliance intricacies between testing and calibration laboratories within the framework of this standard. 

This presentation examines the fundamental differences and critical aspects of testing and calibration laboratories, as well as commonalities within ISO/IEC 17025:2017. 

Testing involves the evaluation and analysis of materials or systems against specified criteria, while calibration focuses on determining the accuracy of measurement equipment against known standards. 

A side-by-side comparison of testing and calibration laboratories is attempted, highlighting their individual objectives, quality management systems, technical competencies, and proficiency testing protocols as mandated by ISO/IEC 17025:2017, as well as many other controversial aspects such as metrological characteristics, measurement uncertainty, compliance decision, reporting the results, risk management, and more. 

The presentation intends to allow laboratories, quality managers, and professionals in comprehending, implementing, and optimizing the testing and calibration processes within the ISO/IEC 17025:2017 requirements, reinforcing the reliability and trustworthy laboratory practices. 

Instructor Biography

Instructors: 

Emil Hazarian - MSCEMIL HAZARIAN, Prof. Dipl. Ing. 

Quality Assurance, MS 

Mechanical Engineer, MS 

Metrology, BS 

Professor CSU Dominguez Hills,  

MSQA/BSQA Programs, 

Measurement Science Conference (President 2011) – NIST Seminars, Tutorials. ASQ-CCT 

NCSLI Member Delegate 

International Accreditation Services Technical Advisory Council Member 

213-392-2495, emil.hazarian@csudh.edu 

Professor Emil Hazarian, has an extensive experience in Metrology, Quality Assurance, Standardization, Engineering, and Manufacturing. He was tasked by the US Department of Commerce as Advisor in Quality Management, Standardization and Metrology for Europe and acted as an advisor for professional groups from NIST, NASA, JPL, Southern California Edison and other large companies.  

  Professor Hazarian is currently teaching metrology classes in MSQA/BSQA Programs, at CSU Dominguez Hills. He is member of the International Accreditation Services Technical Advisory Council 

  He authored and contributed to several metrology books including: 

  • “The Metrology Handbook”, ASQ Press, 2004 (2011), co-author.
  • “Elements of Measurement Techniques”, 2000.
  • “Mechanical Variables Measurement”, CRC Press, 2000, co-author. 
  • “Handbook of Measuring Instrumentation and Sensors”, CRC Press, 1999, co-author.
  • “Mass Measurement Techniques”, NIST/OWM contract, 1995.

He also is the author of more than 50 technical articles, lectures and tutorial workshops on metrology-accreditation-standardization-quality related topics delivered at the metrology conferences, including California State University Dominguez Hills, MSC, NCSLI, IMEKO, NSWC Corona Division, California, US Navy, Spanish Air Force (SAF), Indian Navy, and more. 

Emil Hazarian is also a Certified Lead ISO 9001 and Lean Six Sigma Assessor, as well as a Lead Quality and Technical Assessor for ISO 17025 accreditation bodies. 

2023 Anniversaries Highlights: 

  • Metrology/Engineering – 56 yrs. 
  • Quality Assurance – 36 yrs.
  • University Teaching – 26 yrs.
  • Measurement Science Conference – 36 yrs.


T11: INTERNAL AUDITING OF YOUR ISO/IEC 17025 ACCREDITED LABORATORY

HALF DAY COURSE PM: 

Tuesday, March 26th: 1:00pm – 5:00pm

Instructors: Prafulla Yelve, Prasanth Ramakrishnan, International Accreditation Service (IAS)

Abstract

ABSTRACT:

This tutorial aims to teach practical internal auditing skills to individuals familiar with the activities of an ISO/IEC 17025 accredited laboratory. We will examine auditing principles and techniques and practice internal auditing skills. While the tutorial is based on internationally recognized approaches to conducting internal audits, we will also draw on attendees’ practical laboratory experience, as well as ensure that the requirements of ISO/IEC 17025:2017 for an internal audit are understood. The course includes easy-to-implement methods for risk-based thinking, continual improvement, and closing out findings through the analysis of root causes aimed at their elimination. 

Instructor Biography

Instructors: 

Mr. Prafulla Yelve - MSCPraful Yelve is working as Technical Liaison- South Asia with IAS and he is responsible for engaging with customers by providing technical support and handling their queries to meet their expectations. Praful also conducts test and calibration laboratory assessment as a lead and technical assessor as per ISO/IEC 17025 and qualified assessor for ISO17020 and ISO17021-1 too. 

Praful was previously employed as the General Manager for Indian Conglomerate Godrej & Boyce Mfg Co. Ltd. and headed their Calibration & Inspection business for more than 15 years before joining IAS in year 2020. He is member of technical organizations such as Metrology Society of India (MSI) and NCSL International (NCSLI). He also conducts training/workshop related to laboratory activities such as ISO17025 Awareness, Internal Auditing, Measurement Uncertainty, Metrology and Calibration, Risk Assessment etc.  

Mr. Yelve’s academic background includes a Diploma in Mechanical Engineering with experience in Calibration, Testing, Inspection and additionally he has done several certification courses in calibration and testing domain. 

Prasanth S Ramakrishnan - MSCMr. Prasanth S Ramakrishnan is the Senior Manager working for International Accreditation Service (IAS). He is a Mechanical Engineer with a Masters’ in Mechanical and Industrial Engineering from Texas Tech University.  He is active member of technical organizations such as American Society of Quality (ASQ) and member of the Asia Pacific Accreditation Cooperation (APAC) proficiency testing committee. 

He has conducted numerous assessments and training sessions on conformity assessment standards for many testing and calibration laboratories to ISO/IEC 17025.  He also conducted many assessments across other conformity assessment standards. His expertise is focused on management systems, mechanical and geotechnical sectors. He has participated and presented in technical discussions, accreditation criteria meeting hearings, miscellaneous conferences and trade shows.  


T12: METROLOGICAL CHARACTERISTICS OF MEASURING DEVICES

HALF DAY COURSE PM: 

Wednesday, March 27th: 1:30pm – 5:00pm

Instructor: Emil Hazarian, Prof.-Dipl. Ing. – BS Metrology, CSU Dominguez Hills, MSC

Abstract

ABSTRACT:

To ensure reliable and consistent measurements, it is imperative to understand the metrological characteristics of measuring devices.  

This presentation will provide attendees with a comprehensive understanding of the metrological characteristics of measuring devices and their practical implications, emphasizing on measurement traceability and measurement uncertainty 

Whether you are a scientist, engineer, technician, or simply interested in the science of measurement, this knowledge will enhance your ability to make informed decisions and ensure the quality of your measurements.  

Instructor Biography

Instructor: 

Emil Hazarian - MSCEMIL HAZARIAN, Prof. Dipl. Ing. 

Quality Assurance, MS 

Mechanical Engineer, MS 

Metrology, BS 

Professor CSU Dominguez Hills,  

MSQA/BSQA Programs, 

Measurement Science Conference (President 2011) – NIST Seminars, Tutorials. ASQ-CCT 

NCSLI Member Delegate 

International Accreditation Services Technical Advisory Council Member 

213-392-2495, emil.hazarian@csudh.edu 

Professor Emil Hazarian, has an extensive experience in Metrology, Quality Assurance, Standardization, Engineering, and Manufacturing. He was tasked by the US Department of Commerce as Advisor in Quality Management, Standardization and Metrology for Europe and acted as an advisor for professional groups from NIST, NASA, JPL, Southern California Edison and other large companies.  

  Professor Hazarian is currently teaching metrology classes in MSQA/BSQA Programs, at CSU Dominguez Hills. He is member of the International Accreditation Services Technical Advisory Council 

  He authored and contributed to several metrology books including: 

  • “The Metrology Handbook”, ASQ Press, 2004 (2011), co-author.
  • “Elements of Measurement Techniques”, 2000.
  • “Mechanical Variables Measurement”, CRC Press, 2000, co-author. 
  • “Handbook of Measuring Instrumentation and Sensors”, CRC Press, 1999, co-author.
  • “Mass Measurement Techniques”, NIST/OWM contract, 1995.

He also is the author of more than 50 technical articles, lectures and tutorial workshops on metrology-accreditation-standardization-quality related topics delivered at the metrology conferences, including California State University Dominguez Hills, MSC, NCSLI, IMEKO, NSWC Corona Division, California, US Navy, Spanish Air Force (SAF), Indian Navy, and more. 

Emil Hazarian is also a Certified Lead ISO 9001 and Lean Six Sigma Assessor, as well as a Lead Quality and Technical Assessor for ISO 17025 accreditation bodies. 

2023 Anniversaries Highlights: 

  • Metrology/Engineering – 56 yrs. 
  • Quality Assurance – 36 yrs.
  • University Teaching – 26 yrs.
  • Measurement Science Conference – 36 yrs.


T13: IMPLEMENTING MEASUREMENT SYSTEMS ANALYSIS, STATISTICAL PROCESS CONTROL AND PROCESS CAPABILITY STUDIES

HALF DAY COURSE PM: 

Wednesday, March 27th: 1:30pm – 5:00pm

Instructor: Mark Lindsey

Abstract

ABSTRACT:

Many industrial customers require suppliers to provide objective evidence on the capabilities of their processes to consistently meet their customers’ requirements.  This tutorial will cover how to perform a MSA, SPC, and Process Capability Study.  

The topics and subtopics are based on the ASQ Certified Quality Engineer Body on Knowledge topics associated with the control and improvement of product and service processes.  It is also based on the AIAG APQP (Advanced Product Quality & Planning). 

Instructor Biography

Instructors: 

Mark Lindsey - MSCMark has over 35 years of experience in multiple industries developing QMS and implementing TQM, Six Sigma, and the Toyota Production System/Lean (TPS).  He has been serving in a variety of engineering roles internally and with customers and suppliers.  

During the last 20 years he has served on the Education Committee of the American Society of Quality (ASQ) Orange Empire Section where he is the instructor for many of the ASQ Certification Preparation Courses. 

Mark has been working for 20 years at Disneyland as a Principal Engineer supporting Safety, Quality Assurance, Manufacturing, Maintenance, and Supplier Management.  He is an adjunct Professor at CSUF teaching Quality and Project Management for the last 10 years and received the Part Time Instructor of the Year Award. He also serves on the MSC committee. 


T14: GXP METROLOGY: A STRATEGIC APPROACH TO BIOPHARMA CALIBRATION PROCESS MANAGEMENT

3/4 DAY COURSE:

Wednesday, March 27th: 10:45am – 5:00pm

Instructor: Miguel Cerezo

Abstract

ABSTRACT:

This tutorial provides an overview of industry best practice calibration process management solutions that are tailored towards optimizing compliance while reducing costs and providing significant competitive advantage. Several examples of innovative calibration process improvements will be described. The course will provide a thorough review of fundamental calibration concepts and regulatory requirements.  Consideration for optimizing cGMP calibration service provider qualification and approval will be provided as well. 

Instructor Biography

Instructors: 

Miguel Cerezo | MSCMiguel Cerezo is currently the Facilities and Engineering Site Head at Kite Pharma’s flagship T-Cell therapy commercial manufacturing facility (TCF03) in El Segundo, California. He has responsibility for all engineering, maintenance, construction project management, calibration and EHS operations at the site.  He joined Kite in 2018 serving as Head of Facilities, Engineering and Operations for Kite’s network of Research, Development and clinical Manufacturing Centers located in Santa Monica and Emeryville, CA as well as in Gaithersburg, MD. 

Prior to this, Miguel was a founding Engineering Technical Director in Amgen’s Corporate Engineering Technical Authority.  As the recognized company subject matter expert in the fields of Instrumentation, Measurement, Reliability and Controls, he led a team of 4 engineers and 10 other technical staff and was responsible for company-wide ownership and establishment of Engineering Standards, Specifications and Maintenance Requirements for Instrumentation and Controls.  Miguel was Amgen’s Corporate Calibration and Maintenance Quality Process Owner, its Maintenance and Operations Global Network Leader and served in the capacity of its Chief Metrologist.  Also, he was the corporate business process owner of Amgen’s global instance Maximo engineering asset management system.   

Upon coming to Amgen in 1996, he proceeded to quickly advance in escalating levels of management responsibility within the Thousand Oaks Site Facilities and Engineering organization culminating in becoming Director of Facilities and Engineering, where he oversaw all aspects of F&E operations at Amgen’s Thousand Oaks (ATO) headquarters facility.  As the ATO Site F&E Head, Miguel led an organization of 130 staff members and was accountable for all organizational activities including safety, compliance, operations, budgeting ($55M expense and $40M capital annually) and staffing of multiple departments including Engineering, Site Project Management, Work Order Planning and Administration, Site Utilities and Operations, Maintenance, and Instrumentation.  

Prior to joining Amgen, Miguel spent 10 years at Cal Tech’s Jet Propulsion Laboratory (JPL) under contract with NASA where he began his technical career in the Earth Orbiting Systems Group focusing on the development and worldwide field operation of precision sub-centimeter accuracy GPS receivers and microwave water vapor radiometers used in tectonic geodesy and very long baseline interferometry. Subsequently, Miguel was a member of the technical staff in the JPL Instrumentation Section where he developed and implemented testing and calibration solutions for the Spacecraft Environmental Testing Laboratory and the Metrology Standards Laboratory.  During this time, he contributed to the mission success of many NASA space flight projects including Galileo, Cassini, Hubble Space Telescope Wide Field and Planetary Camera, Mars Pathfinder, Sojourner Mars Rover and TOPEX/Poseidon among many others. Additionally, Miguel had primary responsibility for the Active Cavity Radiometer Pyrheliometer system that was deployed to the World Radiation Center in Davos Switzerland to establish and maintain the World Radiometric Reference for solar irradiation measurements. 

A fixture in professional societies and industry forums with numerous published technical papers and presentations to his credit, including contributions to the ISPE GAMP Good Practice Guide: A Risk-Based Approach to Calibration Management, NCSLI RP-15: Inter-laboratory Comparisons and NASA Reference Publication RP 1342 Metrology, Calibration and Measurement Process Guidelines,  Miguel attributes much of his professional success to the teaching and mentoring that he received from senior colleagues while serving as a Program Manager for the NASA headquarters sponsored Metrology and Calibration Working Group and as the NCSLI Region 8 Los Angeles Section Coordinator during his formative years.   

Presently, Miguel is the committee treasurer and Board Chairman of Measurement Science Conference. Additionally, Miguel served as a Board Director for the Los Angeles Chapter of the International Society of Pharmaceutical Engineers.   

On a personal note, Miguel, a native of Madrid Spain, his wife and family live in Thousand Oaks, California.  Apart from enjoying epic family road trips, his past times include fishing and golfing (badly), rooting on his favorite hockey team (GO KINGS GO!) and sorting through the massive Bronze Age comic book collection he’s managed to assemble.  He holds an undergraduate degree in Physics from Occidental College and a Master of Science degree from CSU Dominguez Hills in Quality Assurance. 

 


T15: GWP: GOOD WEIGHING PRACTICES – A SCIENCE-BASED APPROACH TO BALANCE AND SCALE METROLOGY

HALF DAY COURSE PM: 

Wednesday, March 27th: 1:30pm – 5:00pm

Instructor: Ian Ciesniewski 

Abstract

ABSTRACT:

The modern understanding of weighing metrology has had to change!  

The traditional approach of treating weighing in the same way as less nuanced disciplines of metrology has caused a mix of too much testing, inappropriate testing and often use tolerances that are too tight to be realistic for the given location/application. This results in a significant number of methods not actually achieving their metrological goals! 

Authorities have recognized that the roll-off of the measurement uncertainty components of an electronic weighing device is very different than the uncertainty roll-off on mechanical balances and scales.  

National and International Standards are being updated to reflect modern mass metrological science.  

We will break down how measurement uncertainty exhibits itself across the capacity of an electronic balance or scale and cover how to correctly assess and assign a Measurement Uncertainty budget.  

We will discuss modern, robust, risk-based approaches to the assessment and estimation of significant, contributing uncertainty components in order to build a thorough, scientifically-sound, risk-based program for bench or floor weighing instruments. 

Time will be spent covering phenomena that affect the accuracy of weighing, to illustrate how easy it is to create poor weight data!  To contrast this, you will learn how to overcome these potential sources of error, and optimize a balance metrology and service regime. This course focuses on:  

  •  User testing  
  •  Balance location and set up 
  •  Factors influencing Measurement Uncertainty  
  •  Common problems, and how to overcome  
  •  Factors influencing repeatability  
  •  Personal weighing technique 
  •  Service needs for balances and scales 
  •  Increasing productivity from your weighing equipment 

Instructor Biography

Instructors: 

Ian Ciesniewski - MSCIan Ciesniewski is currently a Technical Director for Mettler Toledo Inc. and has been with the company for over twenty-two years. Before his current position, he held that of Market Manager for two years.  Ian has also lived in Switzerland for three years as a Corporate Sales Trainer and in the United Kingdom for over five years in Sales. 

As Technical Director for Mettler Toledo, Ian manages the Mass Metrology business in the United States. He provides technical direction in technical Metrology and regulatory issues. He is also responsible for developing and implementing strategies for the scientific measurement market, specifically, regulatory compliance for pharmaceutical, biotechnology and related industries. Ian also delivers technical education and development to MT lab weighing sales forces in North America. 

Ian holds a Bachelor of Science Degree in Chemistry from Keele University and holds a PhD in Organic Chemistry from The University of Manchester 


T16: OUT OF THE LABORATORY: WEIGHTS AND MEASURES IN EVERYDAY LIFE

HALF DAY COURSE: 

Wednesday, March 27th: 1:30pm – 5:00pm

Instructor: Pilar Carrillo 

Abstract

ABSTRACT:

A discussion of “legal metrology” and what Weights & Measures regulatory officials do to ensure equity and secure confidence in the marketplaceWhile metrology laboratories deal in verifications, calibrations, applications of uncertainties and traceability to national and international standards, the resulting field standards are used to reach far beyond grocery store scales and gasoline pumps in assuring “certainty” for both buyers and sellers at all levels of daily commerceA look at what we all take for granted…. but shouldn’t. 

Instructor Biography

Instructors: 

Pilar Carrillo - MSCMr. Carrillo is a Southern California native, born and raised in the San Gabriel ValleyHe attended Cal Poly Pomona where he earned a Bachelor of Science degree in Animal ScienceMr. Carrillo joined the L.A. County Dept. of Agricultural Commissioner/Weights & Measures in 2004 as an Associate Inspector in the Price Verification Division, serving the next 7 years in Weights & Measures regulatory activitiesIn 2011, Mr. Carrillo became Supervisor of the Business Practices/ Investigation Division, directing Packaged Commodity (Quantity Control) Inspection, Package Labeling Enforcement, Weighmaster Regulation, Undercover Test Purchase (transaction verification), and other retail transaction and motor fuel fraud investigation activitiesIn October 2021, he was promoted to the rank of Deputy Agricultural Commissioner/Sealer of the Business Practices/Investigation DivisionMr. Carrillo has spent 18 years conducting Weights & Measures regulatory activities and now overseeing Weights and Measures regulatory operations within his current division assignment.