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TEACHING SUBJECT

Immunohematology / Blood Banking / Transfusion Medicine

EDUCATION

1. Bachelor of Science (BS) (San Diego State University)
2. Post-graduate studies: Immunohematology (Long Beach State University)
3. Specialist in Blood Bank (SBB) - ASCP Immunohematology Certification
4. Quality Auditor Certification (CQA) – ASQ Certification
5. Six Sigma Green Belt (SSGB) Certificate – Gwinnett Technical College
6. Baldrige Examiner, Board of Examiners, 2012 Georgia Oglethorpe
7. Baldrige Examiner, Board of Examiners, 2013 Georgia Oglethorpe
8. Six Sigma LEAN Leader Training (industry & healthcare) - completed

PROFESSIONAL LICENSE / CERTIFICATIONS

• Six Sigma Greenbelt (SSGB) - Certificate of Completion

Ìý Ìý Ìý Ìý Gwinnett Technical College, Atlanta, GA

• Certified Quality Auditor (CQA) Certificate - Retired

Ìý Ìý Ìý Ìý American Society for Quality (ASQ)

• Specialist in Blood Banking (SBB) Certificate - Active

Ìý Ìý Ìý Ìý American Society of Clinical Pathologists (ASCP)

• Clinical Laboratory Scientist (CLS) License - Active

Ìý Ìý Ìý Ìý State of California

PROFESSIONAL ACTIVITIES

• Licensed Clinical Laboratory Scientist (CLS) (State of California) - Analytical problem-solving skills; Multi-task & goal-oriented performer; Strong comprehension of Immunohematology / Blood Banking; excellent technical skills
• Certified Quality Auditor (CQA) - Performed 1st party / internal and 2nd party / supplier audits; perform quantitative scoring audits; Past AABB Lead Assessor: CLIA auditor (deemed-status); CAP Team Auditor
• Technical Writer - Policies, Procedures, Forms, Job Aids, and Regulatory Licensing applications and approvals (biologics & medical devices), Audit / Inspection Response Letters to State, local, & Federal Agencies.
  • American Association of Blood Banks (AABB) Lead Inspector - Retired
  • College of American Pathologist (CAP) Team Inspector Transfusion Medicine / Donor Center - Retired
  • Blood Centers of California (BCC) - Board Member - Retired

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PROFESSIONAL MEMBERSHIPS

• California Blood Banks Society (CBBS) – Member Active
• American Association of Blood Banks (AABB) – Member Active
• American Society for Clinical Pathology (ASCP) – Member Active
• American Society for Quality (ASQ) – Member Active

EXPERIENCE SUMMARY - ( Greater than 40 yrs;Ìý ÌýScope: Biologics, Healthcare & Medical Devices )

Positions Held:

• Blood Bank line staff Hospital Trauma Center
• Blood Bank Supervisor Hospital Trauma Center
• Assistant Laboratory Director Donor Center
• Laboratory Director
• Regulatory and Quality Director
• Quality Manager (13 Donor Centers Nation -wide)
• Global Director, Regulatory and Quality Affairs
• Vice President, Regulatory and Quality Affairs
• Facility Laboratory Director
• Pathology Director

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1. Operations Experience - Vast knowledge of the operations of a fully licensed / certified biotechnology company, Medical Devices (IVDs), & a fully licensed / certified clinical laboratory;

1. 1. Experience in the start-up of a new satellite clinical laboratory; Departmental budgets; Staff scheduling, and Human Resource-related activities.
   2. Testing schemes:

• • • CLIA complexity testing categories - (waived, moderate, & high)
    • Clinical / diagnostic testing (manual and automated) of samples and products
    • Technical writing of policies and procedures
    • Process flow using Lean Manufacturing principles
    • Tracking & trending of tests or other monitored items

2. Regulatory Affairs and Quality Assurance Experience - senior-level professional (with medical & scientific background) who is committed to meet domestic or international regulatory & quality goals in a cost-conscious manner while maintaining non-compromising integrity.

1. • Regulatory Affairs:

• • • Over 50 approved biologics product / program licensures including successful FDA licensure of new Source Plasma Blood Establishments
    • Maintain 510k files; Create / maintain medical device CE Technical files
    • Provide strategic planning of successful regulatory goals to increase the Company business
    • Wide-scope of knowledge of & experience in domestic & international regulations in biologics & medical devices

1. • Quality Assurance:

• • • Ensure implementation, enhancement, or improvement of Company-wide Quality Systems applicable to a single site or multi-sites
    • Six Sigma LEAN Trained
    • Validation schemes (equipment / computer & new facility): initiate, create, write, and approve - DQ, IQ, OQ, & PQ
    • Knowledge and experience in Clinical Laboratory Safety, Chemical Hygiene, Radiation Safety, Hazardous and Biohazard Waste Management, and Emergency Preparedness
    • Error Management (management includes discovery, announcing, investigation, assisting in resolution, & follow-up, where applicable) - deviations, Out-Of-Specification (OOS) process, root-cause analysis (RCA), gap analysis, track & trending, Non-Conformance Reports (NCRs), Corrective Action / Preventive Actions Process (CAPAs), product impact analysis, and BPDR to FDA, when applicable

3. Healthcare ( clinical laboratory including transfusion medicine ); >20 yrs experience.
   • Operations ( Clinical Lab / Transfusion Medicine )
     • CLS/ MT licensed - Comprehensive knowledge of the operations of the clinical laboratory
   • SBBcertified - Extensive technical knowledge and experience in immunohematology / blood banking (transfusion medicine, biologics, and blood establishments):
     • Biologics / Blood Establishment: donor collections (whole blood, plasma, apheresis, umbilical cord blood stem cells); donor suitability requirements; donor adverse reactions; viral marker testing schemes (blood, plasma, & tissue); donor deferrals; Lookbacks; Post Donation Information; product quarantine, storage, & distribution
     • Transfusion Medicine: adverse reactions investigations / workups; blood typing, antibody screening; antibody identification (complex multiple antibodies, autoimmune disease, etc.), compatibility testing, operation of cell washer, blood component preparation (FFP, pooled platelets, pooled Cryo, RBC, washed RBC, etc.); blood component therapies including apheresis components; hemagglutination tests
   • Level II Trauma Center; Transfusion Medicine; Trauma Hemotherapy; Oncology Hemotherapy; Neonatal Hemotherapy

4. Industry - Biologics ( whole blood, source plasma, human tissue transplantation, & snake venom ) & Medical Devices ( IVD combination products [ biologics / medical device ] ); >10 yrs combined experience

1. • Regulatory Affairs (RA) ( Implement & Manage, Company FDA Authorized Official )

• • • Regulatory agencies - established communications & working relationship: CBER & CDRH; USFWS; & USDA / APHIS; German Health Authority; CLIA (Regional / Local); State (Clinical Laboratory and Biologics Divisions); Local (Hazardous / Biohazard Waste); TGA of Australia.
    • Other organization working experience: Authorized Representative for EU Medical Devices, AABB, PPTA, CAP, AAB, NMDP, NCCLS, JCAHO, & ISO.
    • Domestic regulations knowledge: 21CFRs [7 (Recalls), 200s (GMPs), 600s (Biologics), 800s (Med Devices, QSR, DHF, DMF), & 1200s (Tissue Transplantation)]; 29CFR1910 (Bloodborne Pathogens); 42CFR493 (CLIA); 29CFR1900 (OSHA & Bloodborne pathogens); 42CFR70 (etiologic agents); 49CFR100 (DOT requirements); ISO 9001:2008; 510k issues; Medical Device Reporting; ISO 13485; Quality Auditing / QSIT.
    • International regulations knowledge: German Health Authority for biologics; EU Medical Device Directives (EC, EEC, MEDDEV); CE-Mark Requirements; EDMA harmonization IVD labeling symbols; ICH guidance documents; Section 801 (Import and Export) of the Federal Food, Drug, and Cosmetic Act; 50CFR14 (Importation, Exportation; and Transportation of Wildlife); 50CFR23 (Endangered Species); Endangered Species Act of 1973, 108th Congress; TGA Listed & Registered Product requirements; ISO 13485.
    • Regulatory submissions - approved with rapid turnaround: biologics facility (start-up, relocation, & existing) & biologics products (new & existing) licensure / registration; FDA BPDR submissions; FDA Annual Reports; CE Mark and Certificate of CE Registration (Annex III); CE Technical File; ISO 9001:2008 certification; ISO13485 preliminary assessment;Ìý Medical Device Establishment Registration, CITES Master File; CITES Re-export permits; Import / Export License permit; APHIS Veterinary permit; & U.S. Certificate to Foreign Government.

1. • Quality Assurance (QA) ( Implement & Manage )

• • • GMPs (Good Manufacturing Practices); QSR (Quality System Regulations & QSIT); GTPs (Good Tissue Practices); Six Sigma Lean Principles / Manufacturing; ISO 9001
    • Quality Systems (corporate & multi-sites, e.g., manufacturing sites, donor centers, & clinical laboratories) including performing audits and use of various quality tools:
      • Process Controls (medical device manufacturing, line clearances, donor donation, PDI, testing, lookback, component preparation, product quarantine, product release, product distribution, etc.)
      • Validation of Equipment, Processes, & facility including Calibration of Equipment
      • Document Control (create & maintain SOPs, forms, record retention, storage, archive)
      • Quality Auditor (perform internal & supplier quantitative audits to measure quality compliance and detect concerned areas; manage / control / host regulatory (3rd party) audits.
      • Staff Trainer
      • Quality Systems implementation & maintenance; process control GMPs
      • Error Management (management includes discovery, announcing, investigation, assisting in resolution, & follow-up, where applicable) - deviations, Out-Of-Specifications (OOS) process, root-cause analysis (RCA), gap analysis, track & trending, Non-Conformance Reports (NCRs), Corrective Action / Preventive Actions Process (CAPAs), product impact analysis, and BPDR to FDA, when applicable.
      • Customer / Supplier Complaint System

PUBLICATIONS

• Won, W., Nasr, P., Enhancing the Clinical Science Curriculum: Insights from Graduates and Clinical Rotation Experiences at ºÃÉ«ÏÈÉú, Dominguez Hills, submitted June, 2023.
• Won, W., QualTex Laboratories: Atlanta, The Pulse, November, 2012, p. 2, Internal Company Newsletter.
• Won, W., Chapter 10: Human Tissue Regulation, 2004 Fundamentals of EU Regulatory Affairs, Regulatory Affairs Professional Society (RAPS), Rockville, MD 20852, 2004.
• Hirose, T., Won, W. et. al., A Comparison of Maternal Infectious Disease Marker Rates in Taiwanese and USA Umbilical Cord Blood Donors, Abstract # 4065, Blood, Vol. 98, No. 11, page 106b, November 16, 2001.
• Won, W., Standards for Establishments Collecting Source Plasma, International Quality Plasma Program (IQPP), American Blood Resources Association (ABRA), 1st Edition, 2001.
• Won, W., Methods 6: Blood Collection, Storage, and Component Preparation, AABB, Technical Manual, Contributor, 13th Edition, 1999.