index

Fundamentals of Instrumentation:Demonstrates good understanding of the LC Theory and ConceptsDemonstrates a good understanding of the LC Hardware Components to a functional levelDemonstrates the ability to Acquire data and perform routine data reviewIndependently perform routine parameter set up for all LC modesDemonstrate the ability to install an LC-MSUnderstands the PM process for LC SystemsDemonstrate the ability to repair an LC SystemInstallation:Can describe and perform installations of optional hardware/software componentsDemonstrate the ability to installCan properly unpack, install , plumb and attach electrical connectionsCan efficiently and consistently install the unit in all component variationsCan identify and configure optional componentsDemonstrates good understanding of the instrument’s acquisition software installation and operationCan install and configure appropriate AAOCan execute basic acquisition and data analysisService & Maintenance Procedures:Demonstrate the ability to PMCan identify PM kits required based on PM typeCan install all PM parts requiredDetermines when a PM is requiredDemonstrates good understanding of how to remove, disassemble, reassemble and reinstall instrument’s ion optics, detector etc. Disassembles and assembles all modulesCan replace critical parts and return the system to full functional state.Wears protective eye wear, gloves and where applicable lab coat and handling samples Demonstrate the ability to repairCan adjust, rebuild or replace assemblies as required by the repair procedureHardware Fundamentals & Operation:Demonstrates good understanding of the HPLC components to a functional levelIdentifies all standard componentsDescribes Component functionCan describe intra-module variationsDemonstrates good understanding of the theory and operations of HPLC Can describe basic chromatographic separation parametersRelates the parameters to the graphical representationRelates the chemical and hardware properties to the corresponding separation parametersCan identify and explain the different types of chromatography Understands the difference and application of Isocratic and gradient chromatographyUnderstands the difference and application of different stationary phasesUnderstands the difference and application of different mobile phases Can describe and perform installations of optional hardware/software componentsCan properly install , plumb and attach electrical connectionsCan identify and configure optional componentsDemonstrates good understanding of the instrument’s electronic operation (i.e. which PCB controls a particular function, where to go for key measurements, which power supply provides power to a particular component etc.) Can properly install , plumb and attach electrical connectionsTroubleshoots the right assembly based on symptoms and troubleshootingUnderstands influence of varies assemblies on a specific process or behaviorUses proper test points and relates the feedback to instrument performance

Day 3

Training Program

Learner Description

IQ/OQ Automation HPLC

The training program assumes the trainee matches the following profile: Sciex employee onlyOperational experience on LC/MS Workflow experienceFSE should be able to set up and run a batch using AnalystFSE has the ability to acquire, organize, retrieve and process dataLaboratory experience FSE is familiar with sample preparation techniques (pipet, dilutions, preparation of solutions)FSE understands laboratory safety rulesFSE has good laboratory practicesFSE may have or may not have previous experience with Agilent LC systems Learner ResponsibilitiesCompletes all assigned training tasksLearns service activities of Sciex supported Agilent LC systems and related model differencesRemains actively engaged and participates in all class and lab activitiesLearns and develops the technical skills necessary to perform high quality maintenanceLearns and develops the skills to support customer LC/MS workflowResources available to support the above learnerSharepointSciex installation and service procedures for supported Agilent LC systemsAgilent service manualsMyDevelopment & Off-line playerTraining workbook (not on off-line player)E-learning, videos and presentations on Agilent related service and troubleshooting procedures

LC System overview LC System installation site prepstackingelectrical & communicationplumbingpriming / purgingcheck leaksLC-MS System operation operation with Analystinstallation verification tests

Prerequisites: Completion of the Blue Line or Legacy training program Completion of the Agilent HPLC training pre-class mentoring checklist Required Pre-Learning E-Learning on MyDevelopment: HPLC Generals (4h to 6h) (see below) HPLC Pre-learningSAMPLE INJECTORSHPLC PUMPSColumn Packing materials in Reverse Phase ChromatographyTroubleshooting influence of temperature in HPLCASSESSING CHROMATOGRAPHIC SEPARATORSPre-Learning ExamInstructor Led Training (ILT)Instruments covered Agilent LC systemAgilent 1200Agilent 1260 InfinityAgilent 1290 InfinityService Tools used LabAdvisor, Instant PilotReviewing the basics Basic conceptual understanding of HPLC and MS, and the concept behind LC-MS (review based on the e-learning modules completed before the training start)Safety (EHS Training) Personal safety and the use of PPE (Personal protective equipment) (practice)Nitrile powder-free glovesLab coatSafety glassesSafety Data Sheets related to methanol, acetonitrile, formic acid and triazine (review)Electrical safety (refresh)Good laboratory practices Lab safety and safety of others (refresh)Complying with Customer site requirements (practice)Basic Electronics Electrical safety (refresh)Overview of Agilent 1200, 1260 Infinity, 1290 Infinity LC system OverviewAgilent LC system general conceptSciex supported Agilent modulesResources at Sciex on Agilent LC systemsLC System Installation Pre-site inspectionInstallationStackingElectrical and communication connectionsPlumbing Priming and purge using Instant Pilot or LabAdvisorChecking for leaksPressure Test

Eksigent Ekspert microLC Systems

LC-MS System operation (cont.) operation with Analystinstallation verification testsPlanned maintenance (practice) degasserpumpauto samplercolumn ovendetector

Agilent 1100, 1200, 1260 & 1290 LC Systems

Disassemble & Reassemble degasserpumpauto samplercolumn ovendetectorPlanned maintenance (execution) degasser pumpauto samplercolumn ovendetector

MPX

LC-MS System Operation Connection with mass spectrometerOperation with AnalystInstallation verification testsPressure test (review)System Function Test with Triazine (open tube)Triazine LC-MS/MS WorkflowData analysis with MultiQuantPlanned Maintenance Practice DegasserCheck functionality and leaksPump Purge valve filter, piston seal, seal wash and piston exchange (re-using parts) Autosampler Exchange needle seat, needle, metering valve seal, peristaltic pump, sample loop capillary, switch valve seal (re-using parts) Column oven Check functionality (temperature changes) Detector Check functionality (wavelength calibration & intensity check) Firmware Update rules & processDisassembling & Reassemble DegasserDisassemble & re-assemble Discuss some of the most probable issues and repairs Pump Disassemble & re-assemble Discuss some of the most probable issues and repairs Discuss possible troubleshooting scenarios Autosampler Disassemble & re-assemble Discuss some of the most probable issues and repairs Discuss possible troubleshooting scenarios Column oven Disassemble & re-assemble (column switch valve assembly) Discuss some of the most probable issues and repairs Detector Disassemble & re-assemble (flow cell) Discuss some of the most probable issues and repairsPlanned Maintenance PM execution following the Sciex procedure documentSystem Health Check Pressure test Run the Triazine LC-MS/MS Workflow Sample and mobile phase preparation Edit and optimize method Edit and run batch Process data using MultiQuant Discuss possible troubleshooting scenariosParticipants Maximum 6 learners

Day 4

System Health Check pressure testTriazine LC-MS/MS WorkflowData processing reviewdiagnosticTroubleshooting (exercise)

Shimadzu LC-20, LC-20XR & LC-30

Program Description

Agilent Infinity II

The Training program consists of 4 full working days on training on Agilent LC modules of 1200, 1260 Infinity and 1290 Infinity SeriesThis course covers:Theory of operation of HPLC (refresher based on current learner knowledge) Concepts behind coupling HPLC to a Mass Spec (refresher based on current learner knowledge)Install, PM & RepairFundamental concepts of triaging and troubleshooting LC/MS System: finding root cause using diagnostic tools. Upon completion of this course, the learning will be able to perform the following tasks on Agilent 1200, 1260 Infinity and 1290 Infinity platforms: Site Inspection prior installation of the LC systemInstallation and installation tests (Pressure Test & System Function Test)Basic operation (using Instant Pilot, LabAdvisor & Analyst)Planned maintenanceTroubleshooting: Ability to quickly triage an LC/MS workflow Ability to diagnose using the available customer dataUsing the LC/MS troubleshooting process Using TEAMS to determine root causeRepair of the LC systems Out of scope tasksThe following topics are NOT covered in this training:Agilent 1100 SeriesAgilent Infinity 1290 II Series and Agilent 1260 Infinity II Series (*)Analyst Device Driver (ADD) (*)Agilent LC System IQ/OQ (#)Important:(*) covered in a specialized Agilent Infinity II training workshop. Can be attended only if the Agilent 1200, 1260 and 1290 training (this training) has been completed before. (#) covered in a specialized training. Can be attended only if the Agilent 1200, 1260 and 1290 training (this training) has been completed before.

Day 1

Fundamentals LC/MS Workflow:Can prepare standard samples and HPLC mobile phaseFollows SOP for sample, standard and MP preparation.Can set up an LC/MS systemPurges, prime and equilibrate modules as required.Can create an LC/MS methodProperly creates an LC/MS method and fill all necessary parameter fields.Understand the difference of LC Sync and NO Sync.Knows the particular parameter settings for each moduleCan create and run a sample batchCreates a sample batch from scratch and all necessary componentsCan distinguish between an application and LC/MS issueCan obtain BASIC data using AnalystCan measure peak height and areaDetermines peak retention timeCan process data to obtain calibration curves and results using MultiQuant.Tools & Measurement: Demonstrates proper use of Hand ToolsUnderstands how and why to use ESD kitUses the ESD kit as expected.Understand when ESD is neededDemonstrates safe use of tools and measurement equipmentCan differentiate similar tools: JIS, Phillips, Cross, Hex, torxUses the right tool for the jobUses appropriate safety gear depending of the toolErgonomic tool useTroubleshooting Skills: Understands the need to use a systematic troubleshooting processDemonstrates working knowledge of troubleshooting MS systemsCan interpret data and spectra results to facilitate troubleshooting processPossess the skill to distinguish between an application issue from a hardware issueDemonstrates good understanding of the instrument’s diagnostic softwareEstablishes a connection between diagnostic tests results and system assembliesCan relate the diagnostic feedback to hardware, software or application issues.Uses the right diagnostic tool based on instrument behaviorGood Laboratory Practices:Complies with or oversees the compliance with Laboratory safety policies and procedures both at customers site and at SCIEX facilitiesTakes personal responsibility for safety Wears protective eye wear, gloves and where applicable lab coat and handling samplesUnderstands the proper use of labeling, storage and disposal of chemicals and solventsMakes sure instrument can be safely operatedMakes sure there is proper laboratory ventilation for the Mass Spec before installation and/or operationKeeps a safe working environment during a service activityKnows how to safely use test equipment with live instrumentation

Day 2

Eksigent Nano LC System

Agenda

The evaluation for the associate’s training completion will be based on the following competencies:

Competency

The training program assumes the trainee matches the following profile: Sciex employee onlyOperational experience on LC/MS Workflow experienceFSE should be able to set up and run a batch using AnalystFSE has the ability to acquire, organize, retrieve and process dataLaboratory experience FSE is familiar with sample preparation techniques (pipet, dilutions, preparation of solutions)FSE understands laboratory safety rulesFSE has good laboratory practicesFSE has attended before the mandatory Agilent 1200, 1260 and 1290 Training (ground training for Sciex supported Agilent LC 1200, 1260, 1290 systems)Learner ResponsibilitiesCompletes all assigned training tasksLearns service activities of Sciex supported Agilent LC systems and related model differencesRemains actively engaged and participates in all class and lab activitiesLearns and develops the technical skills necessary to perform high quality maintenanceLearns and develops the skills to support customer LC/MS workflowResources available to support the above learnerSharepointSciex installation and service procedures for supported Agilent LC systemsAgilent service manualsMyDevelopment & Off-line playerTraining workbook (not on off-line player)E-learning, videos and presentations on Agilent related service and troubleshooting procedures

LC System overview major differences with older systemsLC System installation site prepstackingelectrical & communicationplumbingpriming / purgingcheck leaksAnalyst Device Driver installationLC-MS System operation operation with Analyst & Analyst Device Driverinstallation verification tests

LC-MS System Operation Connection with mass spectrometer Operation with Analyst and Analyst Device DriverInstallation verification tests Pressure test (review) System Function Test with Triazine (open tube) Triazine LC-MS/MS Workflow Data analysis with MultiQuantNote: significant amount of time will be spent on familiarizing the FSE with the use of Analyst & Analyst Device Driver Planned Maintenance Practice Pump Purge valve filter, piston seal, seal wash and piston exchange (re-using parts)Disassemble & reassemble pump headsAutosamplerExchange needle seat, needle, metering valve seal, peristaltic pump, sample loop capillary, switch valve seal (re-using parts)Column ovenCheck functionality (temperature changes)DetectorCheck functionality (wavelength calibration & intensity check)FirmwareUpdate rules & processDisassembling & Reassemble PumpDisassemble & re-assemble (front panel)Discuss some of the most probable issues and repairsDiscuss possible troubleshooting scenariosAutosamplerDisassemble & re-assembleDiscuss some of the most probable issues and repairsDiscuss possible troubleshooting scenariosColumn ovenDisassemble & re-assemble (column switch valve assembly)Discuss some of the most probable issues and repairsDetectorDisassemble & re-assemble (flow cell)Discuss some of the most probable issues and repairsPlanned Maintenance PM execution following the Sciex procedure documentSystem Health Check Pressure testRun the Triazine LC-MS/MS WorkflowSample and mobile phase preparationEdit and optimize methodEdit and run batchProcess data using MultiQuantDiscuss possible troubleshooting scenariosParticipantsMaximum 4 learners

The evaluation for the associate’s training completion will be based on the following competencies:

LC-MS System operation (cont.) operation with Analystinstallation verification testsPlanned maintenance (practice) pumpauto samplercolumn ovendetectorDisassemble & Reassemble Focus on: pumpauto sampler

Prerequisites: Completion of the Blue Line or Legacy training program Completion of the Agilent HPLC training pre-class mentoring checklist Completion of the “Agilent 1200, 1260, and 1290 training” Required Pre-Learning E-Learning on MyDevelopment: HPLC Generals (2h to 3h) (see below) Pre-Learning (Complete before training)Agilent Infinity II Service Strategy ReviewAgilent Infinity II OverviewAgilent Infinity II InstallationAgilent Infinity II Installation Knowledge CheckInstructor Led Training (ILT)Instruments coveredAgilent LC systemAgilent 1290 Infinity IICompanion softwareAnalyst Device Driver (ADD)Service Tools usedLabAdvisor, Instant PilotAnalyst Device Driver (ADD, Analyst companion software)Reviewing the basicsBasic conceptual understanding of HPLC and MS, and the concept behind LC-MS (review based on the current need of the learner)Safety (EHS Training)Personal safety and the use of PPE (Personal protective equipment) (practice)Nitrile powder-free glovesLab coatSafety glassesSafety Data Sheets related to methanol, acetonitrile, formic acid and triazine (review)Electrical safety (refresh) Good laboratory practices Lab safety and safety of others (refresh) Complying with Customer site requirements (practice)Basic ElectronicsElectrical safety (refresh)Overview of Agilent 1200, 1260 Infinity, 1290 Infinity & 1290 Infinity II LC system Overview Major differences between Agilent LC system series: 1200, 1260, 1290 and 1290 Infinity II Sciex supported Agilent 1290 Infinity II modules Resources at Sciex on Agilent LC systemsLC System Installation Pre-site inspection Installation Stacking Electrical and communication connections Plumbing Priming and purge using Instant Pilot or LabAdvisor Checking for leaks Pressure Test Installation of Analyst Device Driver (ADD) LC system initialization & configuration using ADD

The Training program consists of 3 full working days on training on Agilent LC modules of 1290 Infinity II Series This course covers: Install, PM & repairFundamental concepts of triaging and troubleshooting LC/MS System: finding root cause using diagnostic tools. Upon completion of this course, the learning will be able to perform the following tasks on Agilent 1290 Infinity II platforms: Site Inspection prior installation of the LC systemInstallation and installation tests (Pressure Test & System Function Test)Basic operation (using Instant Pilot, LabAdvisor, Analyst & Analyst Device Driver)Planned maintenanceTroubleshooting: Ability to quickly triage an LC/MS workflow Ability to diagnose using the available customer dataUsing the LC/MS troubleshooting process Using TEAMS to determine root causeRepair of the LC systemsOut of scope tasksThe following topics are NOT covered in this training:Agilent 1100 SeriesAgilent 1200, 1260 Infinity and 1290 Infinity Series (*)Agilent LC System IQ/OQ (#)Important:(*) The Agilent 1200, 1260 Infinity and 1290 LC systems must have been trained on in a previous mandatory training: “Agilent 1200, 1260 and 1290 training”(#) covered in a specialized training. Can be attended only if the “Agilent 1200, 1260 and 1290 training” has been completed before.

Disassemble & Reassemble (cont.) Focus on: pumpauto samplerSystem Health Check pressure testTriazine LC-MS/MS WorkflowData processing reviewdiagnosticTroubleshooting (exercise)

This course will cover the theory of operation of Eksigent pumps, concepts behind coupling HPLC to a Mass Spec, performing Install, PM & Repair. Fundamental concepts of triaging and LC/MS System will be covered teaching learners to find root cause using diagnostic tools.Upon completion of this course the learning will be able to perform the following tasks on M3 Micro, MicroLC200 and Express HT:Install & perform Site InspectionMaintain Systems & Perform PMTroubleshooting: Ability to quickly triage an LC/MS workflowAbility to diagnose using the available customer dataUsing the LC/MS troubleshooting processRepairing of the systemsOut of scope tasks:The following modules are excluded from this training: IQOQ

Module Assembly, Disassembly and repairs Pumps CTC AutosamplerSet Up System Integration Test (Trap/Elute)

Prerequisites Training Programs: Completion of the Blueline or Legacy API / QTRAP Training program Required Pre-Learning: Learners should set side approximately 4 to 6 hours to complete the pre-learning: Eksigent Pre-learning Intoduction to Eksigent HPLC Pre-learning Sample Injectors HPLC Pumps Column Packing materials in Reverse Phase Chromatography HPLC UV/VIS Detectors Mobile Phase, Modifiers and Sample Clean Up Solvent filtration and degassing in Reverse Phase Chromatography Troubleshooting influence of temperature in HPLC Assessing Chromatographic Separations Pre-Learning Exam Instructor Led Training (ILT) Instruments covered Liquid Chromatography M3 MicroLC MicroLC200 Express HT Service Tools CTC Tool Roll Reviewing the Basics Basic conceptual understanding of HPLC and MS, and the concept behind LC-MS Theory of operation of Eksigent pumpsSafety (EHS Training) Personal safety and the use of PPE (Personal protective equipment) Nitrile powder-free gloves Lab coat Safety glasses Electrical safety

Legacy Systems MicroLC200Express HTTroubleshooting Course Wrap Up

Presentations Introduction to MicroLCMicroLC- PumpsMicroLC - AutosamplerSet Up UnpackingKitsStackingElectricalCommunicationsFirmwareCTC configuration Running Hardware DiagnosticsPurging Checking for leaks, pressure testPlumbingSystem Integration Test (Direct Inject)

Good laboratory practices Lab safety and safety of others Complying with Customer site requirements Basic Electronics Electrical safety Using a DVM Out of scope: Using a High Voltage probe, which is not required for this training phase HPLC (Eksigent MicroLC) ELearning Introduction to Eksigent Pre-site Inspection Electrical Proper benches Lab ventilation Lab Supplies are available or need to be ordered Lint free wipes Gloves Pipettes and tips Installation Unpacking Kits Stacking Electrical Communications Firmware CTC configuration Running Hardware Diagnostics Purging Checking for leaks, pressure test Plumbing System Set-up System Integration Test Direct Injection Trap/Elute PM Pumps PM Autosampler PM Module disassembly, assembly and repairs. Troubleshooting Participants Maximum 6 Learners

The training program will assume the trainee matches the following profile. Operational experience on LC/MS Workflow experienceFSEs should be able set up a batch run using AnalystAbility to acquire, organize, retrieve and process dataLaboratory experienceFamiliar with sample preparation techniques (Pipet, Dilutions, Preparation of solutions)Understands Laboratory SafetyHas Good Laboratory PracticesResources available to support the above learnerThese resources can be found in myDevelopment & the offline player Operational experience on LC/MS Workflow experienceFamiliar with sample preparation techniques (Pipet, Dilutions, Preparation of solutions)

Good laboratory practices Lab safety and safety of others Complying with Customer site requirements Basic Electronics Electrical safety Using a DVM Out of scope: Using a High Voltage probe, which is not required for this training phaseHPLC (Eksigent MicroLC) ELearning Introduction to Eksigent Pre-site Inspection Electrical Proper benches Lab ventilation Lab Supplies are available or need to be ordered Lint free wipes Gloves Pipettes and tips Installation UnpackingKitsStackingElectricalCommunicationsRunning Hardware DiagnosticsPurging Checking for leaks, pressure testFlushingAutosampler SetupPlumbingcHiPLCSystem Set-up System Integration TestPM Pumps PMAutosampler PM Module disassembly, assembly and repairs. Troubleshooting Participants Maximum 4 Learners.

Day 5

Module Assembly, Disassembly and repairs 400 pumpAS3 autosamplerPresentation NanoLC – cHiPLC Set Up System Integration Test with cHiPLC

Presentations Introduction to NanoLCNanoLC - PumpsSet Up UnpackingKitsStackingElectricalCommunicationsRunning Hardware DiagnosticsPurgingChecking for leaks, pressure testFlushing

Prerequisites Training Programs: Completion of the Blueline or Legacy API / QTRAP Training program Required Pre-Learning: Learners should set side approximately 4 to 6 hours to complete the pre-learning: Eksigent Pre-learning Intoduction to Eksigent HPLC Pre-learning Sample InjectorsHPLC Pumps Column Packing materials in Reverse Phase Chromatography HPLC UV/VIS Detectors Mobile Phase, Modifiers and Sample Clean UpSolvent filtration and degassing in Reverse Phase ChromatographyTroubleshooting influence of temperature in HPLCAssessing Chromatographic Separations Pre-Learning Exam Instructor Led Training (ILT) Instruments covered Liquid Chromatography 400 Series nanoLC Ultra Classoc Service Tools Stainless steel sample needle Reviewing the Basics Basic conceptual understanding of HPLC and MS, and the concept behind LC-MS Theory of operation of Eksigent pumps Safety (EHS Training) Personal safety and the use of PPE (Personal protective equipment) Nitrile powder-free gloves Lab coat Safety glasses Electrical safety

This course will cover the theory of operation of Eksigent pumps, concepts behind coupling HPLC to a Mass Spec, performing Install, PM & Repair. Fundamental concepts of triaging and LC/MS System will be covered teaching learners to find root cause using diagnostic tools.Upon completion of this course the learning will be able to perform the following tasks on 400 series, Ultra and Classic: Install & perform Site InspectionMaintain Systems & Perform PMTroubleshooting: Ability to quickly triage an LC/MS workflowAbility to diagnose using the available customer dataUsing the LC/MS troubleshooting processRepairing of the systemsOut of scope tasks:The following modules are excluded from this training: IQOQ

Module Assembly, Disassembly and repairs Cont. Ultra pumpAS2 autosamplerClassic PumpClassic AutosamplercHiPLC

Presentations NanoLC - Autosampler Set Up Autosampler SetupPlumbingSystem Integration Test

Troubleshooting Course Wrap Up

InstallationCan describe and perform installations of optional hardware/software components in the LC IQ/OQ processDemonstrate the ability to install and use all components in the kitsCan properly unpack, install , plumb and attach electrical connections of components in the kitCan identify and configure optional componentsCan efficiently and consistently install the components of the automation kits in different LC configurationsDemonstrates good understanding of the instrument’s acquisition software installation and operationService and Maintenance ProceduresHas prior understanding of LC operation and when they need servicingHardware Fundamentals & OperationDemonstrates good understanding of the HPLC components to a functional levelIdentifies all standard componentsDescribes Component functionDemonstrates good understanding of the theory and operations of HPLC (separation of peaks)Can describe basic chromatographic separation parametersRelates the parameters to the graphical representationRelates the chemical and hardware properties to the corresponding separation parametersUnderstands the difference and application of Isocratic and gradient chromatographyCan describe and perform installations of optional hardware/software componentsCan properly install , plumb and attach electrical connectionsDemonstrates good understanding of the instrument’s electronic operation (i.e. which pcb controls a particular function, where to go for key measurements, which power supply provides power to a particular component etc.)Troubleshoots the right assembly based on symptoms and troubleshooting if neededUnderstands influence of various assemblies on a specific process or behaviorcGxP Regulatory ComplianceUnderstands the importance of good record keepingUnderstands the importance, functionality and processes of the qualification softwareUnderstands the difference between a deviation and an exceptionUnderstands the importance of kit component calibration statusFollows qualification manual and software instructions thoroughlyProperly notes deviations and exceptionsUnderstands the importance of obtaining training certificationsUnderstands the proper report handling proceduresUnderstands the differences between and IQ/OQ and PQ and when to use themUnderstands the purpose of an IQ/OQ

Prerequisites:Completion of an LC Training classPre-Learning (5-7hrs)ELearning on MyDevelopmentInstructor Led Training (ILT)Instruments coveredLCShimadzu, Agilent (Exigent if available)IQ/OQ kitFlowmeter, thermocouple etc.Safety (EHS Training)Personal safety and the use of PPE (Personal protective equipment)Nitrile powder-free glovesLab coatSafety glassesElectrical safetyGood laboratory practicesLab safety and safety of othersComplying with Customer site requirementsBasic TroubleshootingConfiguration Troubleshooting Ensuring that computer, flow meter and other components are setup correctlyParticipantsMaximum 6 Service Technicians (if 2 or 3 stacks/kits are available)

Fundamentals LC/MS WorkflowCan prepare standard samples and HPLC mobile phaseFollows SOP for standard and MP preparation.Can set up an LCsystemPurges, prime and equilibrate modules as required.Can create a method in AnalystCan measure peak height and areaDetermines peak retention timeKnowledge & Function of Tools & MeasurementDemonstrates proper use of hand toolsUnderstands how and why to use all components in the Automation kit (thermocouple, flowmeter, laptop, detector)Demonstrates installation and use of all components in the Automation kit (thermocouple, flowmeter, laptop, detector)Ergonomic and safe tool useGeneral Troubleshooting SkillsUnderstands the need to use a systematic Troubleshooting ProcessDemonstrates working knowledge of troubleshooting LC systems and computersCan interpret data and spectra results to facilitate troubleshooting processPossess the skill to distinguish between an application issue from a hardware issueDemonstrates good understanding of the instrument’s diagnostic softwareEstablishes a connection between diagnostic tests results and system assembliesCan relate the diagnostic feedback to hardware, software or application issues.General Laboratory PracticesComplies with or oversees the compliance with Laboratory safety policies and procedures both at customers site and at SCIEX facilitiesTakes personal responsibility for safety – (wears protective eye wear, gloves and where applicable lab coat) and handling samplesUnderstands the proper use of labeling, storage, and disposal of chemicals and solventsMakes sure instrument can be safely operatedMakes sure there is proper laboratory ventilation for the Mass Spec before installation and/or operationKeeps a safe working environment for self and others during a service activityKnows how to safely use test equipment with live instrumentationFundamentals of InstrumentationDemonstrates good understanding of the LC Theory and ConceptsDemonstrates a good understanding of the LC Hardware Components to a functional levelDemonstrates the ability to Acquire data and perform routine data reviewIndependently perform routine parameter set up for all LC modesUnderstands the PM process for LC SystemsDemonstrate the ability to repair an LC System if something goes wrong in class

The training program will assume the trainee matches the following profile: Has attended a Shimadzu and Agilent courseOperational experience on LC/MS Workflow experienceFSEs should be able set up a batch run using AnalystAbility to acquire, organize, retrieve and process dataLaboratory experienceFamiliar with sample preparation techniques (Pipet, Dilutions, Preparation of solutions)Understands Laboratory SafetyHas Good Laboratory PracticesLearner ResponsibilitiesCompletes assigned training tasksDevelops an understanding why an IQ/OQ is preformed and how to execute an IQ/OQ

Lecture: Introduction, theory, background Lecture: Pre-site and completion processes Lab: Setup equipment and run 1st IQ/OQ

This course will cover Installation Qualification(IQ) and Operation Qualification(OQ) procedures for LC units. IQ/OQ’s of Shimadzu and Agilent stacks will be included in the course. Additional stack may be covered depending on training facility availability.The learner will acquire the knowledge, tools and skills to successfully run an IQ/OQ on an Agilent or Shimadzu stack (including a UV).Out of scope tasksIt is important to understand that the Field Service Engineer will NOT be taught the following items: MS IQ/OQPQ

Lecture: How the IQOQ Automation software works Setup equipment and run 2nd IQ/OQ Go over Eksigent HPLC IQOQ specifics Review Micro200 IQOQ ELearning

(Only half Day) Finish any remaining IQ/OQ runs Wrap-up session; Pack kits

The training program will assume the trainee matches the following profile: Can perform Install, Repair & PM on Shimadzu productsOperational experience on LC/MS Workflow experienceFSEs should be able set up a batch run using Analyst Ability to acquire, organize, retrieve and process dataLaboratory experienceFamiliar with sample preparation techniques (Pipet, Dilutions, Preparation of solutions)Understands Laboratory SafetyHas Good Laboratory PracticesLearner ResponsibilitiesDevelops an understanding of MPX systemsComplete all assigned training tasksLearns installation and nuances related to MPX system installationRemains actively engaged and participates in all class and lab activities Learns and develops the technical skills necessary to perform high quality maintenance and repair on MPX ProductsLearns and develops the required skills to support customers workflow

Electrical installation Prepare MPs and 4 Std curve (LC/MS triazine workflow) MPX software overview Run standard to determine system function (between streams) using both analyst and mpx softwares Set up to run both curves and unknowns overnight

LC-MS overview MPX Theory and component introduction (CBM) Lab- Stacking Plumbing

Process data Troubleshooting (diagnosis using MPX software) Hardware troubleshooting exercises (plumbing and electrical)

Prerequisites: Completion of Shimadzu Training class Completion of a Blueline or legacy training Pre-Learning (~3-4hrs) ELearning courses on MyDevelopment Completion of the CTC-pal pre-learning SAMPLE INJECTORS HPLC PUMPS Column Packing materials in Reverse Phase Chromatography HPLC UV/VIS DETECTORS MOBILE PHASE, MODIFIERS AND SAMPLE CLEAN-UP Solvent filtration and degassing in Reverse Phase Chromatography Troubleshooting influence of temperature in HPLC ASSESSING CHROMATOGRAPHIC SEPARATIONS Pre-Learning Exam Instructor Led Training (ILT) Instruments covered MPX Shimadzu Autosampler CTC Pal Autosampler Mass spectrometer Blueline or legacy Service Tools MPX Diagnostic (Part of MPX software) Safety (EHS Training) Personal safety and the use of PPE (Personal protective equipment) Nitrile powder-free gloves Lab coat Safety glasses Electrical safety Good laboratory practices Lab safety and safety of others Complying with Customer site requirements

This course will cover the theory, installation, plumbing and operation of the MPX system. MPX software, data analysis, data acquisition & processing will also be covered in this course. The learner will acquire the knowledge, tools and skills to successfully install an MPX system. They will acquire skills to troubleshoot and service certain parts of the system. In addition, this program will capture MPX workflow and will enable the learner to run samples, process data, and assess data to diagnose system issues. Out of scope tasksIt is important to understand that the Field Service Engineer will NOT be taught the following items:IQ/OQ of the systemLearners will not learn how to perform service & PM on Shimadzu

InstallationCan describe and perform installations of optional hardware/software components in the LC IQ/OQ processDemonstrate the ability to install and use all components in the kitsCan properly unpack, install , plumb and attach electrical connections of components in the kitCan identify and configure optional componentsCan efficiently and consistently install the components of the automation kits in different LC configurationsDemonstrates good understanding of the instrument’s acquisition software installation and operationService and Maintenance ProceduresHas prior understanding of LC operation and when they need servicingHardware Fundamentals & Operation Demonstrates good understanding of the HPLC components to a functional levelIdentifies all standard componentsDescribes Component functionDemonstrates good understanding of the theory and operations of HPLC (separation of peaks)Can describe basic chromatographic separation parametersRelates the parameters to the graphical representationRelates the chemical and hardware properties to the corresponding separation parametersUnderstands the difference and application of Isocratic and gradient chromatographyCan describe and perform installations of optional hardware/software componentsCan properly install , plumb and attach electrical connectionsDemonstrates good understanding of the instrument’s electronic operation (i.e. which pcb controls a particular function, where to go for key measurements, which power supply provides power to a particular component etc.)Troubleshoots the right assembly based on symptoms and troubleshooting if neededUnderstands influence of various assemblies on a specific process or behaviorcGxP Regulatory ComplianceUnderstands the importance of good record keepingUnderstands the importance, functionality and processes of the qualification softwareUnderstands the difference between a deviation and an exceptionUnderstands the importance of kit component calibration statusFollows qualification manual and software instructions thoroughlyProperly notes deviations and exceptionsUnderstands the importance of obtaining training certificationsUnderstands the proper report handling proceduresUnderstands the differences between and IQ/OQ and PQ and when to use themUnderstands the purpose of an IQ/OQ

Fundamentals LC/MS WorkflowCan prepare standard samples and HPLC mobile phaseFollows SOP for standard and MP preparation.Can set up an LCsystemPurges, prime and equilibrate modules as required.Can create a method in AnalystCan measure peak height and areaDetermines peak retention timeKnowledge & Function of Tools & MeasurementDemonstrates proper use of hand toolsUnderstands how and why to use all components in the Automation kit (thermocouple, flowmeter, laptop, detector)Demonstrates installation and use of all components in the Automation kit (thermocouple, flowmeter, laptop, detector)General Troubleshooting SkillsUnderstands the need to use a systematic Troubleshooting ProcessDemonstrates working knowledge of troubleshooting LC systems and computersCan interpret data and spectra results to facilitate troubleshooting processPossess the skill to distinguish between an application issue from a hardware issueDemonstrates good understanding of the instrument’s diagnostic softwareEstablishes a connection between diagnostic tests results and system assembliesCan relate the diagnostic feedback to hardware, software or application issues.General Laboratory PracticesComplies with or oversees the compliance with Laboratory safety policies and procedures both at customers site and at SCIEX facilitiesTakes personal responsibility for safety – (wears protective eye wear, gloves and where applicable lab coat) and handling samplesUnderstands the proper use of labeling, storage, and disposal of chemicals and solventsMakes sure instrument can be safely operatedMakes sure there is proper laboratory ventilation for the Mass Spec before installation and/or operationKeeps a safe working environment for self and others during a service activityKnows how to safely use test equipment with live instrumentationFundamentals of InstrumentationDemonstrates good understanding of the LC Theory and ConceptsDemonstrates a good understanding of the LC Hardware Components to a functional levelDemonstrates the ability to Acquire data and perform routine data reviewIndependently perform routine parameter set up for all LC modesUnderstands the PM process for LC SystemsDemonstrate the ability to repair an LC System if something goes wrong in class

Basic Electronics Soldering and splicing wires Installing an NI-USB connection box Basic Troubleshooting Using the LC/MS troubleshooting process Troubleshooting the installation Plumbing troubleshooting Leaks Location of connections Proper fittings Electrical Troubleshooting Synching issues Switching issues Troubleshooting between streamsPressure differencesRetention time differences Workflow Troubleshooting: Using traizine to evaluate an MPX workflow issue interpreting data to identify an MPX workflow issue Pre-site Inspection Electrical Proper benches Lab ventilation Lab Supplies are available or need to be ordered Lint free wipes Gloves Pipettes and tips Installation Unpacking Kits Stacking Electrical Communications Plumbing Purging and priming with isopropanol and water Checking for leaks, pressure test Connect to MS Installing MPX software and drivers Participants Maximum 4 learners per MPX system.

PM Execution cont. LC-MS Triazine Workflow Data review, triage & TEAMS Course Wrap Up

Basic Electronics Electrical safety Using a DVM Out of scope: Using a High Voltage probe, which is not required for this training phase HPLC (Shimadzu) ELearning HPLC Concept Introduction to HPLC UnpackingUnpacking the Shimadzu and Exion Modules Pre-site Inspection Electrical Proper benches Lab ventilation Lab Supplies are available or need to be ordered Lint free wipes Gloves Pipettes and tips Installation Unpacking Kits Stacking Electrical Communications Plumbing Purging and priming with isopropanol and water Checking for leaks, pressure test System Set-up Prime and purge SFT (Open tube) PM practice (reusing parts) Pumps PM Injectors PM Detectors PM Oven PM Degasser PM Check Module disassembly, assembly and repairs. Troubleshooting scenarios are inserted thorough. Rack, Vial and Port Teaching Rack Changer Teaching Firmware Updates PM Execution (new parts) System Health check (SFT with CFC column testing) Participants Maximum 6 Learners.

Module Assembly, Disassembly and repairs InjectorsDetectorsOvenDegasser

Shimadzu Web Interface PM Practice Pumps PM Injectors PMDetectors PMOven PMDegasser PM CheckModule Assembly, Disassembly and repairs Pumps

Prerequisites Training Programs: Completion of the Blueline or Legacy API / QTRAP Training program Required Pre-Learning: Learners should set side approximately 4 to 6 hours to complete the pre-learning: Shimadzu Pre-learning LC-20 and LC-30 Hardware differences LC-30 Unpacking LC-30 Stacking and Installing HPLC Pre-learning Sample Injectors HPLC Pumps Column Packing materials in Reverse Phase Chromatography HPLC UV/VIS Detectors Mobile Phase, Modifiers and Sample Clean Up Solvent filtration and degassing in Reverse Phase Chromatography Troubleshooting influence of temperature in HPLC Assessing Chromatographic Separations Pre-Learning Exam Instructor Led Training (ILT) Instruments covered Liquid Chromatography Shimadzu LC-20 Shimadzu LC-20 XR/Exion AC Shimadzu LC-30/Exion AD Exion LC Pump (Shimadzu LC-20 AD) Service Tools Shimadzu Web Interface Putty Software Shimadzu F-Update Tool RS-232 to Optical converter USB to RS-232 adapter Reviewing the Basics Basic conceptual understanding of HPLC and MS, and the concept behind LC-MS Safety (EHS Training) Personal safety and the use of PPE (Personal protective equipment) Nitrile powder-free gloves Lab coat Safety glasses Electrical safety Good laboratory practices Lab safety and safety of others Complying with Customer site requirements

Set Up Unpacking KitsStackingElectricalCommunicationsSerialRS 232PlumbingPurging and priming with isopropanol and waterChecking for leaks, pressure testPrime and purgeSFT (Open tube)

This course will cover the theory of operation of HPLC, concepts behind coupling HPLC to a Mass Spec, performing Install, PM & Repair. Fundamental concepts of triaging and LC/MS System will be covered teaching learners to find root cause using diagnostic tools.Upon completion of this course the learning will be able to perform the following tasks on Shimadzu LC-20, LC-20XR, LC -30 and Exion AC and AD platforms:Install & perform Site InspectionMaintain Systems & Perform PM Troubleshooting: Ability to quickly triage an LC/MS workflow Ability to diagnose using the available customer dataUsing the LC/MS troubleshooting process Using TEAMS to determine root causeRepairing of the systemsOut of scope tasks: The following modules are excluded from this training: Once the learner has completed above the following online modules are available: Shimadzu SIL-30ACMP and its Exion equivalent (To be covered via Online training)Exion LC100 integrated LC unit. (To be covered via Online training)To perform IQ/OQ the learner will need to complete the following training course: LC IQ-OQ for Shimadzu / Exion LC systems listed “Instrument Covered” section.

The training program will assume the trainee matches the following profile. Operational experience on LC/MS Workflow experienceFSEs should be able set up a batch run using AnalystAbility to acquire, organize, retrieve and process dataLaboratory experienceFamiliar with sample preparation techniques (Pipet, Dilutions, Preparation of solutions)Understands Laboratory SafetyHas Good Laboratory PracticesResources available to support the above learner: These resources can be found in myDevelopment & the offline player Operational experience on LC/MS Workflow experience Familiar with sample preparation techniques (Pipet, Dilutions, Preparation of solutions)

Module Assembly, Disassembly and repairs Cont. InjectorsDetectorsOvenDegasserSIL Teaching Rack, Vial and Port TeachingRack Changer TeachingFirmware Updating Putty SoftwareFirmware Up-date ToolPM Execution Pumps PMInjectors PMDetectors PMOven PM