All information below has been altered to a certain extent to protect the confidentiality of the company.  The procedures within have been either created or revised by me.  Should you have any problems obtaining the documents, email me and I will send you a copy: qe_val@yahoo.com Validations Types of Validations and sub-validations I performed. An Incubator / Refridgerator Validation Protocol I revised and used Example Form I used as part of the IQ/OQ on a refrigerator I performed A Master Validation Plan I created for new facility V&V (Verification and Validation) As part of the Analyzer V&V software and harware validation I procured a checklist to verify that the source code would instruct the hardware to function reproducibly and effectively.  This document is a 2 page excerpt of a 15 page checklist. Environmental Monitoring / Microbiology Case of a bacteria that just wouldn't go away - My Approach Quality Assurance and Control A Receiving Inspection Document I created A Line Clearance Protocol I revised As part of the Vendor certification process an agreement I drafted The way I would approach a CPA (corrective and preventive action) Maintenance and Metrology A Maintenance Protocol I created Stability For Reagent Stability, using Arhenius Equation, we determined reagent effectivity had expired when assay fell below the 90% sensitivity and applied a procedure that I helped create Example of Arhenius Methodology Project Management How I manage projects, product development, priorities, and dead-lines. Case Scenarios / Document Examples - Coming Soon: 1.  Fluid Engineering - case scenario where amino acid solution filling was not process capable and my approach to the under-filling dilemma. 2.  Quality Engineering - Conveyor Assembly and Heat Sealing - case scenario where outer cap on large parenteral containers was over or under tolerance specifications for Torque. 3.  A critical halt to IV bag QC release & a mounting Quarantine Backup - how I and a collegue of mine attacked an emergency out-of-tolerance situation with bag burst pressure, where 90% of the bags were failing. 4.  Metrology - Example of a calibration procedure I created for Pipettes. 5.  Chemistry / Immunology - A case scenario where ineffective washing of parts from vendor caused a surge in defect rate in the final inspection and how I helped remedy the situation. 6.  Information and Computer Systems - My approach for combining information from SQL and Access dBases to create an inter-departmental information resource for trending and analyzing product incompliance and customer returns. 7. Information and Computer Systems - Examples of my work in evolving an equipment and incoming receiving dBase systems. 8.  Training in SPC and SQC methods - My approach and lessons I tought to Environmental Monitoring for trending and analyzing LIMS data using statistics and Excel. 9.  Environmental Monitoring - How my suggestions later became reality. 10.  Information and Computer Systems - How I solved my department's local and immediate network problems (Novell.)

All information below has been altered to a certain extent to protect the confidentiality of the company.  The procedures within have been either created or revised by me.  Should you have any problems obtaining the documents, email me and I will send you a copy: qe_val@yahoo.com Validations Types of Validations and sub-validations I performed. An Incubator / Refridgerator Validation Protocol I revised and used Example Form I used as part of the IQ/OQ on a refrigerator I performed A Master Validation Plan I created for new facility V&V (Verification and Validation) As part of the Analyzer V&V software and harware validation I procured a checklist to verify that the source code would instruct the hardware to function reproducibly and effectively.  This document is a 2 page excerpt of a 15 page checklist. Environmental Monitoring / Microbiology Case of a bacteria that just wouldn't go away - My Approach Quality Assurance and Control A Receiving Inspection Document I created A Line Clearance Protocol I revised As part of the Vendor certification process an agreement I drafted The way I would approach a CPA (corrective and preventive action) Maintenance and Metrology A Maintenance Protocol I created Stability For Reagent Stability, using Arhenius Equation, we determined reagent effectivity had expired when assay fell below the 90% sensitivity and applied a procedure that I helped create Example of Arhenius Methodology Project Management How I manage projects, product development, priorities, and dead-lines. Case Scenarios / Document Examples - Coming Soon: 1.  Fluid Engineering - case scenario where amino acid solution filling was not process capable and my approach to the under-filling dilemma. 2.  Quality Engineering - Conveyor Assembly and Heat Sealing - case scenario where outer cap on large parenteral containers was over or under tolerance specifications for Torque. 3.  A critical halt to IV bag QC release & a mounting Quarantine Backup - how I and a collegue of mine attacked an emergency out-of-tolerance situation with bag burst pressure, where 90% of the bags were failing. 4.  Metrology - Example of a calibration procedure I created for Pipettes. 5.  Chemistry / Immunology - A case scenario where ineffective washing of parts from vendor caused a surge in defect rate in the final inspection and how I helped remedy the situation. 6.  Information and Computer Systems - My approach for combining information from SQL and Access dBases to create an inter-departmental information resource for trending and analyzing product incompliance and customer returns. 7. Information and Computer Systems - Examples of my work in evolving an equipment and incoming receiving dBase systems. 8.  Training in SPC and SQC methods - My approach and lessons I tought to Environmental Monitoring for trending and analyzing LIMS data using statistics and Excel. 9.  Environmental Monitoring - How my suggestions later became reality. 10.  Information and Computer Systems - How I solved my department's local and immediate network problems (Novell.)

My Approach and Work Details