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Technology Transfer Sop for Pharmaceuticals

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Technology Transfer Sop for Pharmaceuticals document sample

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									    +1-949-929-8254 voice                                                                      +1-814-286-6425 fax
    cezar@qualityleader.com                     Cezar Lucki                               www.vitalquality.com


OBJECTIVE:
To provide professional services in the area of Quality Assurance / Control, Regulatory Affairs, Quality
/ Validation Engineering, Research & Development, Statistics and/or Management.

ACCOMPLISHMENTS:
       Tracked, pursued, investigated and took corrective action for hundreds of computerized systems for facilities
        in the US and Europe. Brought several ERES projects to a successful conclusion.
       Successfully validated Corrective/Preventive Action, Audit, and NCMR (CATs web) dBase software.
       Managed, planned, strategized, created procedures, and executed facility validation to a successful FDA
        approval for a medium (41,000ft2) electronics medical device company.
       Provided all product transfer activities, including DOE’s, product stability, validations, and clinical
        statistics, to a successful 510k approval at an in-vitro-diagnostics startup company.
       Created Access - SQL dBase system for easy retrieval/entry, flagging, and trending on return products and
        product failures.
       Invented and assisted in patents for improvements of techniques and devices in environmental monitoring.
       Expanded company Access based MRP system using VBA.
       Fully trained departments on statistics, trending, and proper data acquisition and interpretation.
       Trained departments on use of Office applications, Windows, email systems and more.
       Managed 5+ people at a time in product transfer, metrology, warehousing, validations and other.
       Expanded and managed metrology, QE, purchasing, and Info. Systems simultaneously.
       Investigated and found source & reason of microbiological contamination saving company 2 weeks of
        quarantine, 40K units of waste, and $100K+
       Solved numerous Novell based network and LIMS system breakdowns.
       Investigated and solved source of amino acid solution filling process and filling line variance preventing
        waste, creating rapid corrective action, and saving $150K.
       Solved injection molding, blow molding, and film delamination problems with engineers and mechanics.
       Was a contributing Quality Engineering representative board member in the development of new silicone
        barrier dual chamber oxygen sensitive parenteral bag.
COMPETENCIES:
Industries:
  Pharmaceuticals:                           Solids  Semi-solids  IV (Parenterals)  Cosmetics
  Medical Devices (I, II, III):
                                              Nuclear     Lasers    Electronics    Plastics / Film  IVD’s

Guidelines / Standards:
  cGMP / QSR / QS                       GLP (21CFR Part58)            ISO 9001:1994, 9001:2000, 9002
       IEST (IES)                       21CFR Part 11                 29CFR & Title 8 (fed. & Cal. OSHA)
       10CFR (NRC reg’s)                40CFR (EPA reg’s)             ANSI/ASQC Z1.9-1993
       MIL-STD-105E                     ANSI/ASQC Z1.4                Fed. Std. 209E (ISO TC 209-14698)
       USP / BAM                        NIST / ASTM / ACS             MDD (med. dev. directive)
       DOT                              CE Mark / UL                  EU GMP (91/356/EEC, 91/412/EEC)

Government Regulations:
  FDA              NRC                       OSHA              DEA                  DOT               EPA

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 +1-949-929-8254 voice                                                                            +1-814-286-6425 fax
 cezar@qualityleader.com                    Cezar Lucki                                      www.vitalquality.com

Tasks:
  Nuclear Env. Ctrl                  Metrology / Maint.         Product Failure analysis / R&D
  Internal / Vendor Audits           SOP writing                Design of Experiments (DOE)
  IT Support                         QC Chemistry               QC Environmental Monitoring
  QC Chemistry                       QC Microbiology            FMEA / FTA / HA / Design Controls
  QE tools                           R&R (gage study)           Project Plan / Management
  Material Control (Inspections, Purchasing, and Inventory)
  Validations (software, computer, PLC, process, cleaning, equipment, and test methods)
  Personnel Training (statistics, computer app’s., QC techniques, gov’t compliance, validations, etc.)


EXPERIENCE:
Consulting since February 2000 for following clients:

 Irvine Scientific, Irvine, CA                                                                                   Pharmaceuticals
Part-11 Validation Consultant
Validated Blue Mountain Calibration System 4.0. Planned master validation for in-house databases and
DataStream MP2. Created proposals and coordinated validations activities with IT (Computer) department.
Coordinated discounts with software vendor.

 Baxter BioScience, Glendale & WLV, CA                                         Pharmaceuticals
Business Analyst (Technical Analyst) | Part 11 / Global ERES Compliance (IS Quality)
Baxter provides a portfolio of therapeutic proteins derived from either human plasma or recombinant technology.
Assessed GAP and Part 11 compliance over many US and International facilities. Researched best ERES
solutions / technologies for Part 11 compliance, global implementation, user friendliness, and budget capability.
Global ERES budget analysis & application. Developed Validation / SDLC documentation for Computer /
Computerized systems and Software. Provided support for implementation & completion of Corporate Charter.
Client Contact: Darwin Partners (consulting firm) and Michael E. Thompson.
     Vendor / Supplier Assessment & Coordination                              Risk Assessment
     Strategizing solutions with US, German & French facilities               Compliance Matrix / Config. Documents
     GAMP, ISO/IEC 12207, IEEE 1012, IDEF implementation                      User / Functional / Design Req. Specs.
     Meeting coordination, minutes, and planning                              Validation Plan & protocol
     Document verification, assessment, and development                       DCS / MRP / ERP / EDM / PDM
     SCADA / PLC / Environmental Ctrl. Systems                                ERES Team / Global Technical support

 Oread Pharmaceuticals through QST / Oxford, Palo Alto, CA                      Contract Pharmaceuticals
Quality Assurance / Validation Specialist
Oread is a contract pharmaceutical manufacturer of parenterals, liquid, semi-solid, and solid dose
drugs. Supported any Quality Assurance and Validation functions for contract manufacturer. Supported
technology transfer. Projects were performed for clients such as: ICN, Roche, Agouron, Praecis, BioMedicines,
Guilford, Nissan, Dura, Unimed and Xoma. Client contact: Beth Rice, Marji Prows, Tony Brown, Ken Miles
PhD, Arlene Blakes.
    Equipment and Process Validations                                SOP generation and revision
    Cleaning Validations                                             Batch Verification
    Stability Trending                                               Audit Responses
    Internal GMP, Documentation and Facility Audits                  Investigations / Troubleshooting

Permanent Positions from March 1996 until January 2000 for following Employers:

 B. Braun | McGaw, (Validations / QE Dept.), Irvine                     Parenteral Pharmaceuticals / Med. Dev.    4/97 - 8/98
                                                                                                                                   2
 +1-949-929-8254 voice                                                                        +1-814-286-6425 fax
 cezar@qualityleader.com                       Cezar Lucki                               www.vitalquality.com

Quality Engineer Associate II
B.Braun | McGaw is a manufacturer of paranteral pharmaceuticals and medical devices. Validated/requalified
systems, new or revised products, systems, PLC's, and facilities. Investigated product complaints. Technical
training and assistance. Performed plant shutdown operations. Management: Nannette Monreal & John Smith
/ previously Blair Smith
    IQ,OQ,PQ execution and protocol generation                            SOP generation and revision
    Chairing of product eval. and plant coordination meetings             DOE, R&R, Stats. and Mil. Std's
    Personnel training (validations, requal, computer, app., etc.)        Facility Audit


McGaw (QC dept.) (through Lab Support), Irvine             3/96 - 11/96 (f/t) & 11/96 - 4/97 (p/t)
Environmental Monitoring Technician / Media and Sterility Technician
McGaw is a manufacturer of paranteral pharmaceuticals and medical devices. Performed environmental
monitoring. Assisted in sterility testing of final product. Led investigations and performed trending.
Management: Myron Civils & Wendy Ricapito
    Viable testing of water, air, and surfaces.                          Non-viable testing of air, water

SKILLS:
COMPUTER
 Software/O.S.: DOS, some UNIX, Novell, Windows2000/95/3.X/NT/XP/Me, Access, Excel, Word, Power Point, Outlook,
 Adobe Acrobat, Project, Visio, Crystal Reports, Lotus Notes & Organizer, Statgraphics, Statistica, SigmaStat, SigmaPlot,
 DOE programs, Mathematica 2.2, TurboCAD 6.0 and some SolidWorks, Nuero-mapping Apps., most HTML dev.
 programs.
 EDMS/LIMS: MetaPhase / MetaWeb, Documentum, Stratus, SQL-LIMS, CATsWeb
 Programming: BASIC, VBA, some Rockwell RSLogix ladder logic and LabView
 ERP / MRP: MFGPRO, Proteus, Stratus, Vendors&PRO
LANGUAGES Fluent: English / Polish Basics: Spanish and French

EDUCATION:
B.S. Biological Sciences, specializing in microbiology, emphasis in chemistry and psychology at University of California at
Irvine.
* Please visit my website for detailed and in depth analysis of my work
   http://www.vitalquality.com




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+1-949-929-8254 voice                                                     +1-814-286-6425 fax
cezar@qualityleader.com             Cezar Lucki                        www.vitalquality.com


                            TABLE OF CONTENTS

1. PERFORMANCE HIGHLIGHTS
   1.1.     Baxter BioScience
   1.2.     Oread Pharmaceuticals
   1.3.     McGaw | B. Braun - Quality / Validation Engineering
   1.4.     McGaw, Allergan, and Qualisys – Laboratory
       1.4.1. Chemistry
       1.4.2. Biological
       1.4.3. Environmental Monitoring
       1.4.4. Engineering
       1.4.5. Metrology
   1.5.      Documentation
   1.6.      21CFR Part 11 (software, computers, and electronic signatures)
2. COMPLETED VALIDATIONS AND SUBVALIDATIONS
3. CONTINUING EDUCATION




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 +1-949-929-8254 voice                                                                           +1-814-286-6425 fax
 cezar@qualityleader.com                       Cezar Lucki                                   www.vitalquality.com


                                   PERFORMANCE HIGHLIGHTS
                                                Baxter BioScience
                                       (Hyland Pharmaceutical – Plasma, IV)

1.   ERES Remediation Program General Tasks
     1.1. Follow a global approach for ERES remediation
     1.2. Provide a common interpretation of the Part 11 regulation
     1.3. Provide a common ERES remediation strategy
     1.4. Leverage resources and skills across all facilities
     1.5. Manage one divisional ERES budget
     1.6. Promote global collaboration for common solutions
     1.7. Apply a Program Management approach
     1.8. Manage local ERES activities through projects
     1.9. Manage projects through the BioScience ERES Program
     1.10. Govern the ERES Program through divisional and local Regulatory and Business RequirementsQuality Engineering
2.   Project Management
     2.1. Participated as a member of the ERES Core Team to develop common solutions for ERES systems.
     2.2. Developed and maintain project plans for all ERES projects within their functional area.
     2.3. Provided monthly progress reports for each project.
     2.4. Ensured that each remediation project is properly executed at each site.
     2.5. Escalated issues to the Program Director in a timely fashion.
3.   Project Leadership
     3.1. Developed and maintained project plans for a specific ERES project within their site.
     3.2. Lead more than one local project.
     3.3. Provided monthly progress reports for this project.
     3.4. Ensured that the remediation project is properly executed at their site.
     3.5. Escalated issues to the ERES Project Manager in a timely fashion.
4.   Portfolio Management
     4.1. Maintained, inquired, developed, and corresponded for the following:
     4.2. Current list of systems to be remediated
     4.3. Risk assessment of each system
     4.4. Status of each CSV requirement for each system
     4.5. Status of each ERES requirement for each system
     4.6. Estimated cost of remediation for each system
     4.7. Portfolio analysis was recalculated whenever significant changes in budget, estimated costs, or business priorities
           occurred.
5.   Developed and Maintained the ERES Document Repository on Lotus QuickPlace
     The ERES Document Repository (EDR) provided a process and mechanism for promoting the reuse of documents in
     order to reduce duplication of effort and improve quality of documents used to support CSV and ERES compliance. The
     goal was to provide divisional recommendations for documents and templates that can be used by individual sites as the
     basis of their local documentation. These recommended documents were developed from existing “best practice”
     documents obtained from the sites and other sources as may be necessary. The recommended documents were
     constructed from part of more than one document. Recommended documents were used unless an alternative was
     approved.
6.   ERES Implementation Process
     Each site prepared a proposal to request ERES funds for a remediation project. The project addressed more than one
     system and sometimes addressed remediation of all CSV and ERES gaps. The ERES core team reviewed this proposal
     and funds were provided for approved proposals. The implementation approach will included use of available
     documentation in the EDR to fill in documentation and procedure gaps. This documentation was intended to be adapted
     for use by the local site by adding local and technical information.
7.   Project Management Support Process
     Templates and guidelines were stored in the EDR and provided as a part of the implementation packages. The individual
     sites were responsible to select a project leader for the project and provide required local staff to execute the project. The
     Program office provided support for individual projects in preparing project proposals, planning and tracking project
     schedules, preparing project status reports.
8.   Financial Management Process

                                                                                                                                 5
 +1-949-929-8254 voice                                                                     +1-814-286-6425 fax
 cezar@qualityleader.com                   Cezar Lucki                                 www.vitalquality.com

    The ERES program office approved orders. Invoices were processed locally with a copy to the ERES PMO and an entry
    in the IS database. Management reports were provided as necessary.
9. Documentation Management Process
    Documentation produced as a part of the remediation process were retained according to local procedures. The
    program office developed recommended procedures for using an electronic document management system to maintain
    the electronic documents.
10. Inventory Maintenance
    10.1.     Compiled an inventory of systems to be remediated at each site and forwarded it to the ERES-PMO.
    10.2.     Assessed the following:
         10.2.1.        Inventory of systems
         10.2.2.        Compliance status assessment of systems
         10.2.3.        Risk assessment of system according to business requirements
         10.2.4.        Estimated remediation cost
         10.2.5.        Updated Inventory of systems
         10.2.6.        Updated Compliance status assessment of systems
         10.2.7.        Updated Risk assessment of system according to business requirements
         10.2.8.        Updated Estimated remediation cost
11. Documentation Collection, Review, Sorting and Verification
    11.1.     Collected all available system documents, documented procedures and processes from all applicable document
              databases and stored them in the EDR for availability to all sites.
    11.2.     Review and sort the documents collected in the previous step by a numberof parameters.
    11.3.     Documents were indexed by a classification system that allowed easy retrieval for a particular system:
         11.3.1.        Technology specific process documentation & templates:
              11.3.1.1.          By type of system: (i.e. laboratory system or manufacturing process control system)
              11.3.1.2.          By vendor specific solutions: (i.e. HP, Allen Bradley, Siemens, Wonderware, Chem-Station,
                                 etc.)
              11.3.1.3.          By vendor audits (both software and hardware)
         11.3.2.        Common Processes
              11.3.2.1.          Process documentation & templates that are used by all or most systems.
                  11.3.2.1.1.          Specification documents
                  11.3.2.1.2.          User requirements specification
                  11.3.2.1.3.          Functional specification
                  11.3.2.1.4.          System delivery specification
                  11.3.2.1.5.          Software & hardware design specifications
                  11.3.2.1.6.          Vendor audit reports
                  11.3.2.1.7.          Validation documents
                  11.3.2.1.8.          Validation plan
                  11.3.2.1.9.          IQ. OQ, PQ
                  11.3.2.1.10.         Qualification report
                  11.3.2.1.11.         Validation report
                  11.3.2.1.12.         Standard operating procedures (SOP)
                  11.3.2.1.13.         Operation SOP’s
                  11.3.2.1.14.         User SOP’s
                  11.3.2.1.15.         Backup & restore SOP’s
                  11.3.2.1.16.         Access & security SOP’s
                  11.3.2.1.17.         Contingency & disaster recovery SOP’s
                  11.3.2.1.18.         Decommissioning SOP’s
                  11.3.2.1.19.         Archival & retrieval SOP’s
                  11.3.2.1.20.         Configuration management SOP’s
                  11.3.2.1.21.         Training SOP’s
                  11.3.2.1.22.         Audit SOP’s
         11.3.3.        Site Specific Processes & Information
              11.3.3.1.          This information included items such as locations serial numbers, network ID’s, etc.
              11.3.3.2.          Combined, compound and process applicable portions of documents (collected and sorted as
                                 per above) to produce system-specific “best practices” documents that can be used for the
                                 remediation process.
12. High Level Implementation Plan

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 +1-949-929-8254 voice                                                                         +1-814-286-6425 fax
 cezar@qualityleader.com                      Cezar Lucki                                  www.vitalquality.com

      12.1.   Compared a checklist of requirements by site-specific system with the solutions and documents available for
              both system validation and ERES compliance
      12.2.   Reviewed
      12.3.   Compliance status of system
      12.4.   ERES compliance checklist
      12.5.   Validation compliance checklist
      12.6.   Available solutions & documents in EDR
      12.7.   Prepared
          12.7.1.      Completed checklist (by system)
          12.7.2.      Created list of additional solutions/ SOP’s/documents that need to be created to complete the checklist.
13.   Detailed Implementation Plan
      13.1.   Reviewed Site Proposals for requested funds
      13.2.   Based on the following:
          13.2.1.      High level implementation plan
          13.2.2.      Business process description
          13.2.3.      Quotes by Vendor(s)
          13.2.4.      Other cost estimates and product evaluations
      13.3.   Outcome would be:
          13.3.1.      Verify applicability and compliance
          13.3.2.      Request approval from management with justification
          13.3.3.      Creation of: Project Number, Budget, and Implementation Work package
14.   Execution of Remediation Assistance
      14.1.   Project assistance for each site as required, in the areas of:
          14.1.1.      Project management and progress reviews
          14.1.2.      Resolution and elevation of issues
          14.1.3.      Information sharing on of “State-of-Art” technology solutions
      14.2.   Produce:
          14.2.1.      Issue resolution
          14.2.2.      Global Status reports
15.   Process Purchase Orders, Quotes, Requisitions, Invoices
      15.1.   Review and approved Requistions, based on:
          15.1.1.      Relavence
          15.1.2.      Correlation and adherance to proposal
          15.1.3.      Verification with quoted and contractual agreements
          15.1.4.      Review for global discounts
          15.1.5.      Assess for global sharing of technology, software, and documentation.
      15.2.   Acquire management approval, process, and relay approved status:
      15.3.   Update tracking tools with the information:
          15.3.1.      Deviations
          15.3.2.      Scheduling
          15.3.3.      Resources
          15.3.4.      Taxes and contingency
          15.3.5.      Update Reports and Global notification
          15.3.6.      Documentation Status
16.   Access dBase development
      16.1.   Devised a system to input, track, and output reports on:
          16.1.1.      Invoices
          16.1.2.      Proposals
          16.1.3.      Requisitions
          16.1.4.      System ID #
          16.1.5.      Background Info. (location, initiators, approvers, dates, etc.)
          16.1.6.      Reports on Proposal costs for HW, SW, Val by facility and fiscal year, etc.
17.   Team’s Technical Support
      17.1.   Network issues
      17.2.   Technical / Advanced training on MS Office (Excel, Word, Powerpoint, Visio)
      17.3.   Technical / Advanced training on Lotus Notes
      17.4.   Technical / Advanced training & support on various application errors and how to use.
      17.5.   Training of Global and Team members on:
                                                                                                                              7
 +1-949-929-8254 voice                                                                      +1-814-286-6425 fax
 cezar@qualityleader.com                    Cezar Lucki                                 www.vitalquality.com

        17.5.1.       Use of newly developed Access dBase for tracking funds, proposals, Req’s, Invoices, etc.
        17.5.2.       QuickPlace Document Repository use and functions
18. Technologies – within Manufacturing Systems
    18.1.   Allen Bradley PLCs
    18.2.   Siemens S5/S7 PLCs
    18.3.   Klöckner-Möller PLC, Type PS416, PS420
    18.4.   Steris Isolator
    18.5.   Rockwell – RSMACC
    18.6.   GE Fanuc – CIMplicity
    18.7.   Millipore Integra Filter Integrity Testers
    18.8.   Emerson – DeltaV
    18.9.   Intellution – iFIX / FIX32 / FixDmacs SCADAs
    18.10. Intellution – iHistorian
    18.11. Yokogawa Darwin chart recorder
    18.12. FinnAqua – Autoclave, WFI system
    18.13. Siemens – WinCC SCADA
    18.14. Wonderwear SCADA
    18.15. OSI/PI
    18.16. Kaye Validator 2000
19. Process Types – within Manufacturing Systems
    19.1.   Primary Manufacturing Processes (Plasma Fractionation)
    19.2.   Primary Bulk Processes (Recombinants and/or Vaccines)
    19.3.   Primary Processes (Other Products)
    19.4.   Secondary Bulk Process
    19.5.   Separation Processes
    19.6.   Finishing Processes
    19.7.   Aseptic Filling
    19.8.   Plant Utilities WITH product contact
    19.9.   Plant Utilities withOUT product contact
    19.10. Equipment and/or Suite Cleaning processes
    19.11. Secondary Packaging
    19.12. Process Monitoring
20. System Types – within Manufacturing Systems
    20.1.   Client-Server Lab Systems
    20.2.   Data Historian
    20.3.   Databases
    20.4.   Network Infrastructure
    20.5.   PLC
    20.6.   Process Control Systems - PCS (DCS)
    20.7.   Report Generators
    20.8.   SCADA
    20.9.   Spreadsheets
    20.10. Statistical Analysis Systems (SAS)

                                        Tasks at Oread Pharmaceuticals
                                    (contract pharmaceutical manufacturer)
1.   Quality and Validations Engineering
     1.1. SPC/SQC and statistical analysis in OQ and PQ phase of validations.
     1.2. Air change Calculations
     1.3. Sampling and AQL development based on ANSI z1.9 and 1.4
2.   Quality Assurance / Regulatory Affairs / Documentation
     2.1. Cleaning Specifications SOP generation
     2.2. SOP revisions and drafting
         2.2.1.       Maintenance Manufacturing Equipment
     2.3. Audits
         2.3.1.       WFI systems

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 +1-949-929-8254 voice                                                                      +1-814-286-6425 fax
 cezar@qualityleader.com                     Cezar Lucki                                 www.vitalquality.com

          2.3.2.       Internal GMP and OSHA audits
          2.3.3.       Validations Records
      2.4. Batch Verification
      2.5. Batch Manufacturing Specifications Criteria Generation and associated SOP’s
      2.6. Regular Steering Meetings for Validations Coordination
      2.7. Audit Responses to several Clients
          2.7.1.       ICN
          2.7.2.       Roche
          2.7.3.       Agouron
          2.7.4.       Praecis
          2.7.5.       BioMedicines
          2.7.6.       Guilford
          2.7.7.       Nissan
          2.7.8.       Dura
          2.7.9.       Unimed
          2.7.10.      Xoma
      2.8. Stability Trending
3.    Validations (IQ/OQ/PQ) Document drafting, Executions, Summarization / Reporting
      3.1. Manufacturing Equipment
          3.1.1.       Beta Press Tableting Machine.
          3.1.2.       Nordenmatic semi-solid filling machine.
          3.1.3.       Compounding Homogenizing Tanks
      3.2. Process Validation
          3.2.1.       Cream manufactured on Norden
4.    Team IT support
5.    Technical Transfer Support
      5.1. Completion of Validations
      5.2. Audit Responses
      5.3. Client Response
          5.3.1.       Parameter and SOP tracking and completion
          5.3.2.       Calibration Management
          5.3.3.       Manual Tracking
          5.3.4.       Documentation Tracking
          5.3.5.       Stability Tracking
      5.4. Relocation Assistance


                             Quality / Validation Engineering - B Braun | McGaw
        Intravenous Pharmaceuticals & Parenteral Manufacturer
1.      Product complaints investigation - Product Service/Incidence Report (PSR/PIR)
2.      Decontamination processing of returned product (hazardous materials approach)
3.      Physical evaluation
4.      Coordination of product testing with laboratories (e.g. chemistry, microbiological, BTC, engineering, etc.)
5.      Summarization of laboratory results in technical reports
6.      Issuance of corrective action if applicable
7.      Identifying areas of common product issues and presenting suggestions for product improvement and trend analysis
8.      Validations (Installation, Operational, and Performance Qualification) (see Validations & SubValidations)
      8.1. PLC, systems (retrospective), facilities, equipment and product
      8.2. Protocol generation and execution
      8.3. Coordination of validations with applicable departments
      8.4. Validation summarization
9.      Product Test Run Authorization execution and creation of testing method
10.     Some - Design of Experiment generation, coordination and execution
11.     Statistical evaluation with respect to Cpk, confidence level, military standards, etc.
12.     Final deposition of product based upon the statistical evaluation and product performance
13.     Quality Control Release Verification (QCRV) coordination
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 +1-949-929-8254 voice                                                                          +1-814-286-6425 fax
 cezar@qualityleader.com                       Cezar Lucki                                  www.vitalquality.com

      13.1. Review of Maintenance Orders and assignment of Change Control Validation or QCRV
      13.2. Coordination of sampling plans and required testing with laboratories
      13.3. Release of classified and controlled facilities, distilled/deionized/softened water, compressed air, pumps, steam,
             sterilizers, etc. upon receipt of applicable data in compliance with company and government regulations
      13.4. Addressing problem facilities/systems/products and identifying trends
      13.5. Tracking the maintenance progress and laboratory results
14.     Meeting presentations - As Acting Chairperson
      14.1. Product investigation updates and statistical evaluation
      14.2. Validation updates and coordination
      14.3. QCRV / Change Control Request coordination meetings with maintenance department and laboratories
15.     SOP generation/revision and Document Orders
      15.1. Revision of Standard Operating Procedures, Technical Information Standards, etc.
      15.2. Creation of quantitative sampling plan with aid of mil. standards or other statistical approach
16.     Knowledge of Plastics and LVP fabrication / filling
        EXCEL , DUPLEX , PAB , Glass, PIC , Add-A-Vial , addEASE , Compounding, SafeLine®, Injection
                 ®              ™       ®              ™               ®
        Molding, Blow Molding, Film Extrusion
17.     Technical Training of Personnel
      17.1. Computer training - Windows/NT, Excel, Word, Network (Novell), Lotus Organizer & Notes
      17.2. New Test Methods, Validation, QC Release Verification
18.     Technical Assistance
      18.1. Computer, applications, network, printer and other assistance
      18.2. Requalification / Validation approach and procedures
19.     Internal Audits (Routine and unscheduled facilities and process audits)
20.     Involved with teams, in efforts of modernizing and improving specific aspects of the company




                                                                                                                                 10
       (949) 378-1481 voice                                                                            (413) 581-3998 fax
       QEVAL2000@yahoo.com                         Cezar Lucki                           http://qeval.homestead.com


                                                       LABORATORY
                                             McGaw | Braun, Allergan, and Qualisys
   Chemistry
           Infra Red Spectrum analysis - Perkins Elmer (Liquid and Solid)
           Gas Chromotography - Hewlette Packard 6890 II
                   Standards and Sample testing
                   Obtaining results within a minimum of 99% correlation of obtained Linear Regression
                   Maintenance of machine, peripherals, computer, printer, gas delivery, headspace, gas tanks
                   Troubleshooting
           Spectrophotometer (UV and visible)
           pH analysis (Electronic and Titration method)
           Atomic Absorption analysis
           FPLC (Pharmacia) / HPLC (familiarity)
           Fractionating (Pharmacia)
           IMx (Abbott) Spectrophotometry (familiarity)
           Immunoassay techniques / Enzyme reactions (manual / robotics - Tecan / Autolucy Anthos Rosys)
           EIA and use of software to characterize enzyme activity
           Luminescence (Zylux Luminometer system)
   Biological
           Biochemical
                  Electrophoresis
                  Western Blotting
                  Immunoblotting
           Microbial
                  Limulase Amebocyte Lysate (clot) testing of surgical devices
                  Auxonographic testing of Antibiotic affectivity
                  Bioburden testing of air water, plastics, surgical devices, and solutions
                          Filtration and incubated growth on TSA plate
                          Heat Shock
                  Inoculating & Enumeration
                  General biochemical ID techniques
                     Gram Staining, acid-fast stain, OF-Glucose, Oxidase, Catalase, etc.
                  Surface testing (RODAC and Swab)
                  Sterilizer use - Castle / Amsco
    Environmental Monitoring
           Particulate Matter monitoring in water and air using HIAC or MetOne
           Velocity of air using AIRVELO
           Pressure, temperature, and humidity monitoring
           HEPA hood leak testing
           Data trending
           LIMS
    Engineering
           Instron (basics)
           Comparitor
           Oscilloscopes (various)
           Multimeter (Fluke and other)
           Other (Microcalipers, Tensiometer, Fluid / Air flow meters, Pressure gauges, Filter integrity testers, Radiation Dose
             Meters, IR thermometers, Thermocouple / RTD, Kaye Validator Digistrip)
                                                                                                                                     11
   (949) 378-1481 voice                                                                      (413) 581-3998 fax
   QEVAL2000@yahoo.com                        Cezar Lucki                          http://qeval.homestead.com

Metrology
       Micropipettetors and Repeaters (2000 L to 0.5 L) – (3 to 5 point standards)
        Scales and balances (0.1 g to 300kg)
        Thermometers / Thermocouples
        Pressure gauges
        pH meters
        Beakers / Volumetric cylinders / Graduated cylinders


                                                     Documentation

Procedure / Report Writing
     SOP for Manufacturing / Production / Laboratory
             o Aseptic Bottle / Bag filling SOP revisions and inclusion of QA / QC requirements
             o Nuclear Medical Device Manufacturing use, cleaning, and maintenance of equipment
             o Laboratory equipment use, cleaning, maintenance and calibration
     QA / QC / RA procedures
             o QA policies
             o Incoming material / Inspection / Sampling procedures
             o AQL plan implementation into sampling procedures
             o Document Change Control process
             o Master Batch Record
             o Corrective and Preventive Action
     Statistical / SPC / SQC, DOE and R&R Gage study Reports
     Validation (validation plan, IQ, OQ, PQ, reports)
             o Cleaning
             o Production / Lab Equipment
             o Process
             o Test Method
             o Computer / Software
             o Facility / Utility
     Meeting Minutes
     V&V report
     Budget analysis
     FMEA, FTA, and HA procedures
     Audit Reports and Responses
     Metrology (calibration) Procedures
     Preventive / Emergency Maintenance Procedures
     Document Change Control development
             o Approved document types
             o Approval signature process
             o Revision history
             o Release of new document, removal and destruction of previous version
Electronic Storage
     Validation of Documentation System on Access, per Part 11 requirements
     Validation of Blue Mountain Equipment tracking / calibration software
     Use of Excel, Access, and FoxPro for storage and retrieval of documentation information
     Password protection and backup of documentation information
     Use of Stratus (ERP) system for document storage and retrieval
Support and Development of ISO 9001 / Quality System documentation structure, per
     Part 4.16
             o Identify and define the quality information to be collected
             o Develop a quality record keeping system, and develop procedures to maintain and control
     Part 4.5
                                                                                                                  12
   (949) 378-1481 voice                                                                         (413) 581-3998 fax
   QEVAL2000@yahoo.com                        Cezar Lucki                         http://qeval.homestead.com

           o Develop procedures to control quality system documents and data
           o Develop procedures to review, approve, and manage all quality system documents and data
           o Develop procedures to control changes to documents and data
Support and development of QSR/GMP based documentation system, per:
       21CFR Part 820.40 – Document Control
           o Document approval & distribution
           o Document changes and change control
    21CFR Part 820.100 - CAPA
           o Corrective and Preventive action
    21CFR Part 820.180 – Records general requirements
           o Confidentiality
           o Record retention
    21CFR Part 820.181 – Records Device Master record
           o Device specs, production process specs, QA procedures and specs, packaging and labeling specs, installation,
               maintenance and servicing procedures & methods
    21CFR Part 820.184 – Device History Record
    21CFR Part 820.186 – Quality System record.
    21CFR Part 820.198 – Complaint Files


                       21CFR Part 11 (Software, computer, and electronic signatures)

Programming / Debugging
     Debugging and Programming
        Used VBA to modify, debug and augment an existing Access based dBase for storage of equipment, calibration,
        inventory, deliverables, material tree, inspections, label making, report making and documentation system tracking.
Validations – Black Box testing / validations only
     IQ/OQ/PQ validation protocol writing, execution and report
             o Blue Mountain (Equipment / Calibration Tracking software) execution and report
             o AssurX | CatsWEB (custom designed SQL based audit and CAPA (corrective action and preventive action)
                 tracking program)
                       Revision of protocol per Part 11 requirements, Validation Plan, inclusion of functional requirements,
                          creation of IQ/OQ/PQ sections, deleted redundancy and included acceptance criteria.
                       Execution of validation remotely on Target’s (subsidiary of Boston Scientific) server.
             o MS Access based documentation system protocol writing and execution.
             o Vendors & Parts (low end MRP system) writing of validation plan, and IQ/OQ/PQ.
V&V (validation and verification)
     Worked with CSS in developing FMEA, FTA, HA, Design Specifications, and validation plan for Immunoassay
        electronic custom software driven medical device.
Typical Protocol Development
     Validation Protocol – Validation Plan (Master Plan), IQ/OQ/PQ
             o Approval
             o Introduction
             o Ownership / responsibility
             o Overview
             o Discrepancy / Deviation Log and Report
             o Signature Log
             o References
             o Prerequisite Documentation
             o Test Equipment Log
             o Test Cases
                       Objective
                       System Prerequisite
                       Input Specifications
                       Output Specifications
                                                                                                                          13
(949) 378-1481 voice                                                                   (413) 581-3998 fax
QEVAL2000@yahoo.com                    Cezar Lucki                        http://qeval.homestead.com

                     Special Procedureal Requirements
                     Test Procedure
                     Contents of Tables / Attachments for execution
                           Procedural Steps
                           Expected Results
                           Actual Results
                           Pass / Fail
                           Initial Date at end of each page
                           Comments
                           Test Conclusion
                           Tester’s Signature
                           Verification Signature
        o   Installation Qualification
                  Hardware testing
                           Access space
                           Power supply / UPS
                           Network communications
                           Interconnecting wiring / cabling
                           Ambient Temp / Rh
                           Peripheral systems connections
                  Software testing
                           OS / Network and communication software
                           OEM software and custom software
                           Virus checking & Firewall
                           Verification of drive & RAM space
                           Drive configuration
                           Software version numbers
                           Security access for installation and operation
                           Directory configuration
                           Path modification
                           System Parameter configuration
        o   Operation Qualification
                  Testing of specified range of inputs for a data field tested at each end of the range
                  Testing if illogical inputs are accepted
        o   Performance Qualification (not always needed)
                  Executed on complex systems with multiple inputs and outputs as well as network-based systems
                      during times of high user input and high data throughput.




                                                                                                                   14
        (949) 378-1481 voice                                                                  (413) 581-3998 fax
        QEVAL2000@yahoo.com                       Cezar Lucki                    http://qeval.homestead.com


                                   Completed Validations and Sub-Validations

1.   QCRV – Quality Control Release Verification                            4.1.23. Homogenizer
     1.1. WFI –water for irrigation lines                                   4.1.24. Steam, compressed air and WFI
     1.2. Power Plant                                                                 lines
         1.2.1. Holding Tank                                                4.1.25. Facility
         1.2.2. Sterilizers                                                 4.1.26. Beta Press Tableting Machine.
         1.2.3. Still                                                       4.1.27. Nordenmatic semi-solid filling
         1.2.4. Compressed Air                                                        machine.
         1.2.5. Steam and Condensate return lines                           4.1.28. Compounding Homogenizing 2,500
         1.2.6. Co-gens                                                               liter Tanks
     1.3. Clean Room repairs and upgrades                              4.2.      Lab
2.   PTRA – Production Test Run Authorization                               4.2.1. FPLC (Pharmacia)
     2.1. Conveyor PLC change and proximity switch                          4.2.2. Furnace – Ashing (1000 deg. C)
          installation                                                      4.2.3. Refrigerators
     2.2. New Inkjet Printer Installation                                   4.2.4. Freezers
     2.3. Boxing equipment change and installation                          4.2.5. Incubators
3.   Process                                                                4.2.6. Spectrophotometers (Waters)
     3.1. Compounding                                                       4.2.7. Purified, WFI, Distilled and
         3.1.1. Antibody                                                              Deionized water
         3.1.2. Microparticle                                               4.2.8. Bag parallel and cylindrical burst
         3.1.3. Wash buffer                                                           pressure testers
     3.2. Filling Precision and Accuracy                                    4.2.9. Plunger activation machine
     3.3. Pouch Fabrication                                                 4.2.10. Test fixture for Opthalmic laser
     3.4. Bag Fabrication                                                             subassemblies
     3.5. Bottle injection molding design specifications     5.   Cleaning
4.   Equipment                                                    5.1. Compounding Equipment (see Qualisys Task
     4.1. Manufacturing                                                 Highlights)
               4.1.1. Bag washers and rinsers                     5.2. Facility Sanitation
               4.1.2. Washing machines                       6.   Sterilization
               4.1.3. Fillers                                     6.1. Sterilization Tank Validation assistance
               4.1.4. Component Washers and Driers                     6.1.1. Viable and non viable testing
               4.1.5. Injection molding machines                       6.1.2. Pressure and Filter Integrity
               4.1.6. Film extrude                                     6.1.3. Fo Limits - Steam, EtO
              4.1.7. 2 Laser Titanium Welders                          6.1.4. BI testing
               4.1.8. Gamma Counter and auxiliary            7.   PLC
                        equipment                                 7.1. Capping machine PLC change (BB)
               4.1.9. Seed (Source) Assembly Machine              7.2. Bag fabrication Machine (BB) *
               4.1.10. Multi-Channel Analyzer System and               7.2.1. Alarms challenge
                        auxiliary equipment                            7.2.2. Parameter challenge
               4.1.11. Seedburo Seed Counter                           7.2.3. Proximity switches
               4.1.12. Capintec Gamma Dose Calibrator                  7.2.4. Temperature sensors
                        Machine                                        7.2.5. Environmental Controls
               4.1.13. Brachytherapy source Heat Stress                7.2.6. Robotics
                        Equipment                                      7.2.7. Custom built Laser Welding Mach. (U)
              4.1.14. Blow Molders                                     7.2.8. Seedburo seed counter, titanium welder
               4.1.15. Labeling and printing machines             7.3.
               4.1.16. Boxing and ink dispensers             8.   V&V (software and hardware)
               4.1.17. Conveyors and associated                   8.1. FastPack Analyzer
                        mechanisms                                     8.1.1. FTA (fault tree analysis)
               4.1.18. Ultrasonic welders                              8.1.2. FMEA (failure mode and Error analysis)
               4.1.19. Component assembly machines                     8.1.3. Software Validation assistance
               4.1.20. Hoods                                 9.   Test Method Validation
               4.1.21. Stills                                     9.1. QC methods
               4.1.22. Filters (including integrity tests)

                                                                                                                        15
       (949) 378-1481 voice                                                           (413) 581-3998 fax
       QEVAL2000@yahoo.com                     Cezar Lucki               http://qeval.homestead.com

        9.1.1.   QC method for raw components              9.3. Clean Rooms (class 100K to 1K)
                 dimensional testing.                          9.3.1. Main manufacturing facilities
        9.1.2. QC method for sampling of voltage,              9.3.2. Gowning Rooms
                 resistance, capacitance on raw                9.3.3. Airlocks
                 components.                                   9.3.4. Transfer Rooms
        9.1.3. QC test method for biotin binding                     9.3.4.1. HEPA filtration and integrity
                 capacity.                                           9.3.4.2. Room air change
        9.1.4. QC test method for protein purity.                    9.3.4.3. Viable and non-viable air
        9.1.5. QC test method luminescent reagent                    9.3.4.4. Viable surface
                 purity.                                             9.3.4.5. Smoke studies
        9.1.6. QC test method raw material purity on                 9.3.4.6. Positive Pressure
                 reagents and components.                            9.3.4.7. Personnel PM and viable tests.
        9.1.7. QC test method using FPLC for assay.    10. Software Validations (Part 11)
10. Facility Audits and Validations                        10.1. AssurX – Verification of a Customized SQL
    10.1. Power plant                                            based dBase for NCMR, Audit, issues tracking
        10.1.1. Boiler room                                      system (with over 1,000 items)
        10.1.2. WFI                                        10.2. Equipment and Documentation Control System -
        10.1.3. Compressed air                                   Access dBase
        10.1.4. Steam & Condensate Return
        10.1.5. Co-gens & Chillers
    9.2. HVAC and Air Systems




                                                                                                           16
        (949) 378-1481 voice                                                                        (413) 581-3998 fax
        QEVAL2000@yahoo.com                        Cezar Lucki                            http://qeval.homestead.com

                                                 Continuing Education

Accredited Institutions
        University of California at Irvine - Bachelor's of Science, Biological Sciences

Non-credited Training
       Baxter SOP / Procedure Doc. Ctrl. Process (Corporate and facility) – Glendale 6/02
       Baxter CSLC / ERES Corporate process (DM20-02) – Glendale 4/02
       Hazardous Waste Management Training - Allergan, 2/12/97
       OSHA Lab Standard Training Course - Allergan, 2/19/97
       OCRA (Orange County Regulatory Affairs) FDA IVD Workshop - Irvine CA, 2/2/99
       MD&M seminar - BSI registrar and the ISO9000's - Anaheim CA, 2/10/97
       cGMP's - McGaw, Inc. (quarterly 1996, 1997 and 1998)

Accredited Adjuncts
        Ethical Conduct (for Purchasing and Sales) – Baxter L.A. July 16, 2002 (7 hrs CEU)
        IVT (Institute of Validation Technology) – Washington D.C., April 22-25 (24.5 contact hours)
                 Computer and Software Validation and Electronic Records / Signatures Conference
        MD&M (Medical Design & Manufacturing) workshops - Anaheim CA, Feb 1999 (0.4 units)
                 1. Software Verification and Validation of Embedded Systems
                 2. Design Transfer
                 3. Process Validation Guidance
                 4. Defining a Process During the Operational Qualification
                 5. Making Process Validation Continuous with Process Monitoring
                 6. Steps to Implement Design Controls
                 7. Design Controls for Product Development
        MIS154B CMGT574 (CIS Business Communications), On-line, Nov 2000 - University of Phoenix (3 credits)
        Noblitt & Rueland Design Controls Seminar, Irvine CA, Apr 2001 (0.6 units)
        LAN system administrator (M.S.CNA & SyscoCNA), Irvine CA, May 2001 (3 units) – Irvine Valley College
        Landmark Forum – Newport Beach, CA Nov 2000 (3.5 units)
                 Self-improvement course. Techniques for effective management of self and environment.




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