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2012 |

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Project : Network Quailfication
Systems :
Period :
2012.12 ~ ÁøÇàÁß |

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Project : Equipment Validation
Systems :
Period :
2012.11 ~ ÁøÇàÁß |

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Project : Equipment Quailfication Validation
Systems :
Period :
2012.12 ~ ÁøÇàÁß |

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Project : Equipment Quailfication Validation
Systems :
Period :
2012.12 ~ ÁøÇàÁß
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Project : CSV Upgrade Project
Systems :
Period :
2012.11 ~ 2013.01 |

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Project : IT System Validation
Systems :
Period :
2012.01 ~ 2012.09
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Project : CSV Upgrade Project
Systems :
Period :
2012.02 ~ ÁøÇàÁß
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Project : IT System Validation
Systems :
Period :
2012.03 ~ ÁøÇàÁß
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Project : IT System Validation
Systems :
Period :
2012.04 ~ 2012.09
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Project : IT System Validation
Systems :
Period :
2012.06 ~ ÁøÇàÁß
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Project : IT System Validation
Systems :
Period :
2012.04 ~ 2012.09
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Project : Equipment System Validation
Systems :
Period :
2012.08 ~ 2013.01
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2011 |

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Project : ¹é¾Ï°øÀå Áõ¼³°ø»ç Validation Consulting
Systems :
Equipment(50), HVAC, PWS, BMS, WMS
[¼¼ÆÄµ¿(API), ¿ÏÁ¦µ¿, Utilityµ¿, ÀÚµ¿Ã¢°í °øÅë]
Period :
2011.06 ~ 2013.01
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Project : Equipment Validation
Systems :
Period :
2011.06 ~ 2011.08
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Project : Equipment & IT System Validation
Systems :
Period :
2011.07 ~ 2012.04
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Project : IT System Validation
Systems :
Period :
2011.01 ~ 2011.07
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Project : Equipment & IT System Validation
Systems :
Period :
2011.04 ~ 2012.07
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Project : IT System Assessment
Systems :
Period :
2011.08 ~ 2011.09
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Project : IT System Validation
Systems :
Period :
2011.09 ~ 2012.03
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Project : Equipment Validation
Systems :
Period :
2011.09 ~ 2011.10
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2010 |

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Project : IT System Validation
Systems :
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Project : IT System Total Validation
Systems :
ERP, MES, LIMS, WMS, APS, EDMS
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Project : IT System Total Validation
Systems :
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Project : Equipment Qualification
Systems :
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Project : Equipment Qualification
Systems :
Equipment CSV for 20EA
½ÇÇè½Ç Àåºñ CSV
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Project : Equipment Qualification
Systems :
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2009 |

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Project : IT System Total Validation
Systems :
ERP, MES, LIMS, EDMS, WMS, AWS
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Project : IT System Validation
Systems :
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Project : IT System Validation
Systems :
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Project : IT System Validation
Systems :
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2008 |

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Project : Equipment Qualification
Systems :
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Project : Equipment Qualification
Systems :
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Project : Equipment Qualification
Systems :
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Project : IT System Validation
Systems :
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Project : IT System Validation
Systems :
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Project : IT System Validation
Systems :
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Project : IT System Validation
Systems :
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Project : Equipment Qualification
Systems :
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2007 |

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Project : Prospective Equipment Qualification
Systems :
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Project : Prospective Equipment Qualification
Systems :
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Project : Prospective Equipment Qualification
Systems :
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Project : Computer System Validation
Systems :
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Project : Computer System Validation
Systems :
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Project : Computer System Validation for WMS
Systems :
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2006
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Project : General Computer System
Validation consulting and
Computerized System Remediation
project development
Systems :
- All computerized systems,
including Automated Process Equipment, Utilities,
Laboratory Equipment, LIMS, MCS, BMS, EAM, ERP, and Network
Activities:
- Validated Enterprise
Asset
Management (EAM) system
- Helped upgrade Change Control program
- Helped created an inventory of all Computerized Systems
- Developed the Remediation project
- Helped resolve
audit observations
- Developed the Network Qualification project
- Conducted Gap Analysisof all systems for
the Remediation project
- Helped upgrade the Calibration program
- Helped develop the Risk
Assessment
process
- Currently validating the
LIMS
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Project : Prepared
validation protocolsfor Data Logger
software
Systems
- eBro Winlog 2000 Data Logger software
- eBro Winlog Pharm Data Logger software
Activities
- Developed IQ/OQ protocols
- System
review and compliance assessment
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2005 |

(contract with Interface
InfoTech Co. Ltd.) |
Project : Validation
of Laboratory Information Management
System
- PharmMate LIMS (by Interface InfoTech)
Activities:
- Developed a Validation Plan
- Conducted a Risk
Assessment
- System review and
compliance assessment
- Review and Update the URS, FS, and DS
- Developed IQ, OQ, and PQ
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Project : Gap analysis of Tablet PressMachine
Systems
- Sejong MRC-36N Tablet Press System
Activities:
- Reviewed company policies and procedures
- Developed questionnaire
- Collected information and reviewed documentation
- Wrote summary
report of analysis with suggested remediation activities
- Wrote template for summary
report
- Trained employees for conducting Gap Analysis on other systems
|
 |
Project : General
Computer System Validation consulting
Systems
- Computerized System
Validation program
- DeLama Autoclave
- Delta V Manufacturing Control System
(MCS)
- Honeywell Building Management System
(BMS)
Activities
- Helped during client audit and recommended responsesfor audit observations
- Helped develop the Computerized SystemsValidation Master Plan
- Assessed the Autoclave for CSV and Part 11 compliance
- Helped develop OQ Addendum protocolsfor Delta V
- Helped resolve
HVAC problem in the BMS
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2004
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Schering-Plough USA
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Continuation of project from 2003
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2003 |
Perrigo Company |
Continuation of project from 2003 |
Schering-Plough USA |
Project : Retrospective validation of existing equipment
Remediation activities resulting from Consent Decree
from FDA
Systems:
- General manufacturing automated equipment including: Orienters, Labelers, Cappers, Cartoners, SCADA, Label Vision Inspection system
- Tablet manufacturing automated equipment including: Tablet press, Tablet filler, Cottoners, Blister pack machines
- Liquid manufacturing equipment including: Checkweighers, Liquid fillers
- Dry Powder manufacturing automated equipment including: PCS, Verification system, Assembler, Heatsealer
- Aerosol manufacturing automated equipment including: Aerosol filler, Pressure verification system, Leak detection system, Checkweigher
- Bioreactor
Activities:
- Project management
- Reviewed the URS, FRS, and DDS
- Wrote Validation Plans for each equipment
- Developed IQ, OQ, and PQ protocols
- Developed Retirement Plans, Retirement protocols, and Retirement summary reports
- Test execution
- Developed SOPs
- Wrote Validation Summary Reports
- Assisted in replacement system selection
- Part 11 Gap Analysis
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2002 |
 |
Project : Gap analysis of DCS for validation and Part 11
Systems:
Activities:
- Developed questionnaire
- Collected information and reviewed documentation
- Wrote summary report of analysis with suggested remediation activities
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Perrigo Company |
Project : Retrospective validation of existing equipment
Systems:
- General manufacturing automated equipment including: Lifts, Labelers, Cappers, Label Vision Inspection system
- Tablet manufacturing automated equipment including: Blenders, Tablet press, Tablet filler, Blister pack machines
- Liquid manufacturing equipment: Holding/Mixing tanks, Agitators, Pumps, Liquid fillers
Activities:
- Wrote Validation Plans for each system
- Reviewed the URS, FRS, and DDS
- Developed IQ, OQ, and PQ protocols
- Test execution
- Developed SOPs
- Wrote Validation Summary Report
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2001 |
Research Scientists, Inc. |
Project : Validation of a web-based Clinical Trials Software
Systems:
- Web-based Clinical Trials Software
Activities:
- Wrote the MVP
- Reviewed the URS, FRS, and DDS
- Developed operational test scripts and PQ protocol, including Part 11 testing
- Test execution
- Update system under change control Wrote Validation Summary Report
|
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Project : Validation of Laboratory Information Management System (LIMS)
Systems:
Activities:
- Wrote Master Validation Plan (MVP)
- Reviewed the URS, FRS, and DDS
- Developed IQ and operational test scripts
- Reviewed test results
- Wrote Validation Summary Report
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Aventis USA |
Project : Part 11 Gap Analysis
Systems:
- All automated manufacturing and lab equipment
- DCS
- Database Systems
- Enterprise Resource Planning (ERP) software - SAP
Activities:
- Developed questionnaire
- Collected information for each system
- Wrote summary report of analysis, with risk ratings and recommended remediation activities
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2000 |
Enmed |
Project : Validation of a web-based Clinical Trials Software
Systems:
- Web-based Clinical Trials Software
Activities:
- Reviewed the User Requirement Specifications (URS), Functional Requirement Specifications (FRS), and Detailed Design Specifications (DDS)
- Developed operational test scripts and PQ protocol, including 21 CFR Part 11: Electronic Records, Electronic Signatures (Part 11) testing
- Test execution
- Update system under change control
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Aventis USA |
Project : Retrospective validation of existing equipment
Systems:
- Brevetti Liquid Vial Inspection System
- Gettinge Autoclave system
- Building Management System (BMS)
- Water For Injection (WFI) system
- Procal - calibration management software
- Yokogawa Distributed Control System (DCS)
Activities:
- Reviewed existing URS, FRS, DDS, and validation documentation
- Validation using Knapp Set methodology
- Developed IQ, OQ, and PQ protocols
- Test execution
- Developed Standard Operating Procedures (SOP)
- Wrote Validation Summary Reports
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1999 |
Centocor, Inc. |
Project : Validation for facility startup for Remicade
Systems:
- Clean-In-Place (CIP) and Sterilize-In-Place (SIP) skids using Allen-Bradley Programmable Logic Controllers (PLC)
- Process Control System (PCS) workstations using Wonderware Human Machine Interfaces (HMI)
- Supervisory Control And Data Acquisition (SCADA) system
- Product flow controllers
- Mixing tank controllers
- Storage tanks
- Piping
Activities:
- Developed Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocol documents
- Test execution
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