Calvin H. Shirazi, Ph.D.

***** ******* ******

West Hills, CA 91307

(Cell) 310-***-****

Email: adbvbe@r.postjobfree.com

Summary of Qualifications

For over twenty years, I have functioned as the Quality, Validation, Engineering and Compliance Director/Manager or Sr./Staff Engineer for multi-product line FDA regulated and ISO certified OEM and contract manufacturers, producing Pharmaceutical, Biological Reagents, Consumables, Dietary Supplements, Cosmetics, IOL, Dental and IVD Medical Devices (FDA Class II & III) products for companies such as P&G, Bayer and Beckman Coulter.

I have been responsible for Quality, Compliance, Engineering, and Microbiology Departments, providing support, direction and coaching to subordinate personnel in the areas of hiring, training, disciplinary action, problem resolution, work assignment delegation, and career development. I have managed staff of up to 35 including managers, supervisors test engineers, technicians and admins as well as 150 different contractors/sub-contractors, developing and operating within departmental developed annual budget.

I have broad experience in design control, reviews, verifications and validations, pilot production and scale up, design transfer, liquid and solid dose production in a GMP environment (21 CFR 210, 211, 50, 58, 820 & 11), steam, chemical and gamma sterilization, ISO 13485, ISO 14971, MDR, MDD, IVD, biocompatibility assessments, aseptic and clean room operations as well as regulations of governmental agencies such as FDA and OSHA.

I have provided over 100 hours of GMP, GLP, statistics and quality training for production floor employees, technicians, supervisors and managers.

I have hosted over 50 inspections and audits by FDA, OSHA, and the companies’ key customers and providing the vital documentation to satisfy their requirements.

I have performed over 50 domestic and international audits including compliance to GMP and supplier qualification inspections in south America, Asia and Europe including:

Company

Location

Matrox

Montreal, Canada

BIT C2D

Montpellier, France

M-TEK

Budapest, Hungary

Beckman

Krefeld, Germany

Beckman

Marburg, Germany

Measom Freer

Leicester, England

Alcon

Perpignan, France

Alaris

Tijuana, Mexico

I am thoroughly familiar with System Safety Engineering, 510K, CE Mark, CMDCAS, IVD, PMA, Pre IDE, EH&S, PHA, SHA, SSHA, HAZOP, FTA, ESD, ETA, RBD, d/p/sFMEA, FEMECA, HACCP, Reliability, Maintainability, Availability, ISO 13485, ISO 14971, MDD, MDR, Post-Market Surveillance, TQM, ICH, DMR, DHF, DHR, CAPA, DOE, FRACAS, SPC, IEC 60601, EMC, UL, GAMP, ROHS, REACH, DFSS, GxP, Process Automation and Optimization, MEDSAP, MDR 2017, REACH, GD&T, DFA, DFM, DFR, DFX, Kaizen and Lean Six Sigma.

I offer a high energy level, advanced education, up-to-date training, diverse R&D/manufacturing experience and hands on managerial skills.

Professional Affiliations, Education and Certificate Awards

University of Maryland, College Park

Doctor of Philosophy, Reliability Engineering; Mechanical Engineering Department – 2009

University of Maryland, College Park

Master of Science, Reliability Engineering; Mechanical Engineering Department – 2008

California State University, Dominguez Hills

Master of Science, Quality Assurance in Manufacturing & Technology – 2001

Polytechnic University

Bachelor of Science, Chemical Engineering - Certified by “Intl. Evaluation Services”, Brooklyn, NY – 1992

American Society for Quality, ASQ

Certified Quality Assurance Auditor (CQA) – 2002

Certified Quality Assurance Engineer (CQE) – 2002

Certified Six Sigma Black Belt (CSSBB) – 2004

California State University, Dominguez Hills

Certified Environmental and Occupational Health and Safety Officer (EH&S) – 1999

Flexographic Technical Association (FTA), Cal-Poly San Luis Obispo

Certified Flexography Print Operator – 2005

Recent Management Training

Title

Date

Leadership

2019

Workplace Harassment - Manager Edition

2019

Information Technology Strategy and Management

2019

Leave of Absence (LOA) Training for Managers

2019

Affirmative Action Manager Training

2019

Integrity, Compliance and Escalation Manager Training

2019

Information Security Manager Training

2019

Wage and Hour Law - Manager Edition

2019

Published Papers

Shirazi. C. H. (2009). “Data-informed calibration of experts in Bayesian framework”, European Safety and Reliability Association (ESREL), Annual Conference, 2009, Prague, Czech Republic

Shirazi. C. H. (2009). “Data-informed aggregation of experts in Bayesian framework”, The Society for Risk Analysis (SRA), Annual Meeting – Risk Analysis: The Evolution of a Science, December 6-9, 2009, Maryland, USA

Shirazi. C. H. (2009). “Number of Experts vs. Accuracy of Aggregated Estimates: An Empirical Study”, 10th International Probabilistic Safety Assessment & Management Conference (PSAM 10), Seattle, Washington, USA

Professional Experience

Danaher Corporation 2007-Present

Quality Sustaining Engineering Manager, Implant Direct

IVD Manufacturing Engineering Quality Staff Engineer/Technical Manager, Beckman Coulter

Technical management of 15 electronics, mechanical, system, test engineers and technicians

Remediation project management to comply with ISO14971:2012, ISO13485:2016, EU MDR 2017 and MDSAP, Technical Files, DHF, DMR, ROHS, and Process Validations.

Design control, technical assessments and design reviews, pilot scale up, prototype production, design V&V, DHF/DHR management, and design transfer implementation

Validation Subject Matter Expert (SME) and Validation Team Leader (VTL); responsible for design and process V&V of $200+M Urinalysis IVD manufacturing. Prepared Master Validation Plan (MVP) and validation procedures and templates. Conducted equipment qualification (IQ/OQ/PQ), and test method (TMV), non-product software validation, facility, utilities, product and process validations

Participated in Danaher Business System (DBS) and led Six Sigma and Lean projects as VAVE SME achieving material and labor cost reduction by >4% / year, 10% increase in productivity, reducing cycle time by 25%, lowering inventory by 8%, 23% improvement in labor time reduction, and 12% growth in first pass yield (FPY) for the past 10 years; such as improvement of a filling system by reducing the fill volume variation resulting in $900K saving annually as well as increasing production >300% from planned volume when sales demand rapidly increased in 2012

Prepared reliability policies, plans, procedures, protocols and test instructions including Weibull analysis, screening, and unit reliability demonstration tests (RDT).

Post-Market Surveillance

Applied reliability methods such as HALT to uncover design weaknesses and margins.

Design, Process and Product FMEA, FTA, FMECA, HAZOP, HACCP, MLD, & ESD

Evaluated design alternatives; identify manufacturability & serviceability limitations

Analyzed data, design, functional specs to determine conformance with standards

Assisted in obtaining CE Marking, pre-IDE, or 510K

Nonconformance/Complaint, CAPA investigation, implementation and documentation

Conducted Internal and External Quality Audits

Performed cGMP and Statistical Analysis Training

STAAR Surgical, Monrovia, CA

Medical Device (Class III) Manufacturing: Sr./Staff Quality/V&V Engineer 05/05– 05/07

Prepared quality and validation policies and procedures such as Master Validation Plan (MVP)

Conducted equipment qualification (IQ/OQ/PQ), test method, sterilization, product and process validations

Complaint and nonconformances investigation, corrective and preventive actions & documentation (CAPA).

Conducted Internal and External Audits and performed cGMP and Statistical Analysis training

Leiner Health Products; Carson and Garden Grove, CA

Nutritional Supplement & OTC Pharmaceutical Manufacturing: Sr./Staff V&V Engineer 11/02 – 04/05

Prepared quality and validation policies and procedures such as Master Validation Plan (MVP)

Conducted Equipment qualification (IQ/OQ/PQ), Cleaning Validations, Product and Process Validations

Aware Products Inc.; Chatsworth and Simi Valley, CA

Personal Care & Pharmaceutical Manufacturing: Quality Assurance Manager/Director 06/00 - 06/02

Responsible for Quality Assurance, Quality Control, and Microbiology Dept.

Recruited and supervised staff members.

Prepared Quality and Validation documents such as SOP, Master Validation Plan (MVP) and Change Control

Oversee Equipment (IQ/OQ/PQ) and Process Validation,

Handling non-conformance reports, customer complaints investigation, corrective actions and documentation.

Conducted Internal and External Quality Audits and performed cGMP and Statistical Analysis training

Alliance Consumer Intl.; Lynwood, CA

Pharmaceutical Manufacturing: Regulatory Compliance and Engineering Manager 03/97 - 06/00

Responsible for Quality Assurance, Quality Control, and Microbiology Dept. Provided support, direction and coaching to subordinate personnel in the areas of hiring, training, disciplinary action, problem resolution, work assignment delegation, and career development. Developed and operated within departmental annual budget.

Managed staff of up to 28 including managers, supervisors test engineers, technicians and admin staff

Prepared Quality and Validation documents such as SOP and Master Validation Plan (MVP)

Conducted Equipment IQ/OQ/PQ, Process, Cleaning, Sanitization, Water Treatment System Validations

Handling internal non-conformances, customer complaints investigation, corrective actions and documentation.

ChassbSaz Company; Tehran, Iran

Resin Production Plant: Sr. Project/Process Manager 1992 - 1997

Responsible for day-to-day project management including assuring project’s compliance with all applicable government standards and on schedule and on budget execution. Interfaced with government officials and customers as company’s representative for contract and project management. Developed statements of work and negotiate project contracts. Worked with finance and field personnel to produce timely and accurate job progress billings. Recruited and supervised select domestic and overseas project lead and staff members.

Managed staff of up to 35 including managers, supervisors test engineers, and technicians as well as 150 different contractors/sub-contractors, developing and operating within departmental developed annual budget.

Designed and installed process equipment. Equipment optimization and efficiency improvement. Unit operation and process streamlining, process control, process modeling, and process automation. Process troubleshooting.

Technical Expertise

Training

cGMP (21 CFR 210 & 211, 820 & 11)

ISO 13485

Validation Compliance

Audits

Records and Recordkeeping Practices

Corrective Action and Follow-up

Root Cause Analysis and CAPA

Risk Analysis and Hazard Assessment

Statistical Analysis

System Safety Engineering, PHA, SHA, SSHA, HAZOP

FTA, ETA. ESD, MLD, FMEA

Reliability, Maintainability, Availability

TQM, DOE, SPC, Capability Analysis

DFSS, Six Sigma, and Lean Manufacturing

Production & Value (VAVE) Engineering

Design and installation of the process equipment.

Equipment optimization and efficiency improvement.

Unit operation and process streamlining, process control, modeling, and automation.

Process troubleshooting.

System Safety Engineering, PHA, SHA, SSHA, HAZOP

FTA, FMEA,

Reliability, Maintainability, Availability, Preventative Maintenance

TQM, DOE, SPC, Capability Analysis

Statistical Analysis

DFSS, Six Sigma, and Lean Enterprise.

Cosmetics, Nutritional Supplement and Pharmaceutical Validations

Equipment

Utility Systems

MFG/PKG Processes

Lab Instruments

Liquid Fillers

Chilled

Product Validation:

Dispensing Systems

Pumps

Compressed Air Systems

- Liquids

Centrifuges

Packaging Equipment

Plant/Pure Steam Systems

- Tablets

Fume Hoods

Tanks & Mixers

HVAC Systems

- Capsules

Refrigerators & Freezers

Filtration Units

Water Treatment Systems

- Powders

Incubators & Ovens

Storage Chambers

Heaters

- Gels

Autoclaves

Fluid Bed Dryers

Cooling Tunnel

- Ointments

Moisture Analyzer

Sleeve Applicators

- Suspensions

HPLC & GC

Encapsulators

Performance Qualification

Shrink Tunnels

Cleaning Validation

Blenders

Environmental Monitoring

Tablet Presses

Test Methods Validation

Heat Exchangers

Coaters

Coders & Labelers

Granulators

Tapers

Extruders & Molders

Medical Device Verifications & Validations

Systems

Equipment

Optics

Camera, Sensors, Bench, Assemblies, Test Fixtures

Electronics

PCBA, Motors, RFID, Electronics Chassis and Enclosure, Controllers, Assemblies, Test Fixtures

Fluidics

Pumps, Valves, Meters and Detectors, Heaters, Assemblies, Test Fixtures

Mechanical

Drivers and Gears, Molds, Frame and Covers, Assemblies, Test Fixtures

Audits

Contract Manufacturer Qualification: To assure that the manufacturer has the ability to maintain full compliance with cGMP and fulfill your needs.

Contract Laboratory Qualification: Compliance to GLP (21 CFR 58) and GCP (21 CFR 50; Informed Consent, 21 CFR Part 56; Institutional Review Boards, 21 CFR Part 312; Investigators and Sponsors, VA Regulations 38 CFR Part 16; 45 CFR Part 46, and ICH GCP Guidelines; CH-E6) is required for all testing activities associated with the non-clinical or clinical testing.

Supplier/Vendor Qualifications: To assure the vendor’s compliance to cGMP or ISO requirements, developing vendor qualification program and train personnel to execute the qualification plans.

Internal Audits: To assess the completeness of the company’s quality system, train selected internal auditors to be able to identify and define the critical processes and to focus on issues that affect product quality.

Reliability Maturity Assessment: A continuous reliability maturity assessment is required to review the leadership support, reliability policies, procedures, and practices defined by an organization to implement its reliability program with the intent of identifying deficiency and presenting improvements. The assessment determines the level of maturity of existing reliability program in designing, developing, and manufacturing products reflected by the management participation and dedication.

Customer Complaints and Regulatory Inspections

Manage internal non-conformance reports, customer complaints including investigation, corrective actions and preventive measures (CAPA).

Interact with all customers’ representatives and government inspectors and providing the vital documentation to satisfy their requirements including FDA and Cal-OSHA.

Statistical Analysis

Describe the nature of the data to be analyzed and explore the relation of the data to the underlying population.

Create a model to summarize understanding of how the data relates to the underlying population.

Analyze data, acceptance criteria, and functional specifications to determine conformance with standards and established quality, reliability and production requirements as well as process and new material qualifications.

Prove (or disprove) the validity of the model and employ predictive analytics to anticipate future trends.

Ensuring that all components in a design actually behave as intended, and suitably meet predicted performance.

Project Management

Day-to-day project management including assuring project’s compliance with all applicable government standards and on schedule and on budget execution.

Interface with government officials and customers as company’s rep for contract and project management.

Develop statements of work and negotiate project contracts.

Work with finance and field personnel to produce timely and accurate job progress billings.

Recruit and supervise select domestic and overseas project lead and staff members.

DHF, RMF, and Risk Management EN ISO 14971:2012 remediation

RoHS conversion and compliance remediation

REACH compliance

Technical Writing

Developing Quality Manuals, Policies and Plans, Standard Operating Procedures (SOPs), Work Instructions, Test Methods, Specifications, and Change Controls.

Developing Validation Manuals, Validation Master Plans, Protocols, and Reports

Developing Reliability Manuals, Policies, Standard Operating Procedures (SOPs), and test Instructions

Development of presentation materials and a lesson plan.

Communicating complex information in clear and concise way to those who need it to accomplish organizational tasks or goals.

Following development and product lifecycle for:

1.Identification of needs, audience(s), and scope

2.Planning

3.Research and content development

4.Testing, review and revision

5.Delivery / production

6.Evaluation and feedback

7.Disposition (revision, archiving, or destruction)

Reliability

Prepare reliability plans to ensure that resources for a good reliability engineering program are being allocated.

Train the staff in designing for reliability and maintainability

Incorporating failure data and failure analysis in program management.

Assist to budget the allowable system failures down to the component level

Evaluate the reliability potential of alternative designs

Ensure components functionality, and that parts will have suitably designed performance in their lifetime.

Formulate and run tests on components, subsystems, and the system itself.

Provide information to designers on how to improve both the life of a system and its ease of maintenance

Investigate user complaints and field failures.

Set up programs to ensure that field failure data is timely, accurate, well organized, and responded to.

Develop and execute accelerated life testing (HALT, HASS and ALT)

Reliability Planning, Allocation, Failure Modeling, System RGT and RDT.

Develop improved reliability processes and methods to improve the quality and cost effectiveness

Apply advanced engineering mathematics and statistics to reliability engineering tasks, when needed such as; statistical confidence and hypothesis testing, goodness of fit tests, analysis of variance, Bayesian statistics, Poisson Process, Markov Diagrams, and Petri-Nets.

Computer Experience

Statistics: Minitab

Technical Computing: MatLab

Product Safety and Risk Analysis: Dyadem MED-8

Reliability: Weibull++, ALTA, WinSmith, RGA

Personnel Safety and Security: Accusafe Pro

CAPA, Nonconformance, Complaints: CAPA Facilitator, gCAPA

Specification Design and Control: Filemaker Pro, ePDM

Inventory Control and Planning: MAS200, AS400, Oracle ERP

MS Windows: Access, Project, Excel, Word, PowerPoint, Lotus Notes, Visio, Outlook and GroupWise

Technical Drawing: AutoCAD LT, SolidWorks

Field Service: SalesLogic, xFRACAS

Test and Measurement Calibration: GAGEtrak

Maitenance: CMMS

Document Control: EDMS, MasterControl

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