Medical Device Project Manager

FREDERICK J. GASS

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

Cinnaminson NJ 08077

Cell: 609-***-**** Home:856-***-**** Fax: 856-***-****

email: *****@***-****.***

SUMMARY: Medical Device and Pharmaceutical Consultant for 10 years, plus

Direct Positions and FDA experience.

. FDA Investigator - Investigator, cGMP Quality Auditor, Four

+Years, cGMP and QSR / Drugs /Medical Devices / APIs /

Commercial Sterilization. All FDA Training Courses / Part 11.

. Experience: Auditing (16 yrs), Compliance (16 yrs), Quality

Assurance (16 yrs.), Regulator Affairs (4 yrs.), Validations

(15 yrs.), and Commissioning (5-6 Yrs.).

. Validations for Manufacturing Processes, Packaging, Vaccine

Production Facilities, Production Equipment, Laboratory

Instruments, Computers, Systems for BioTech, Medical Devices

and Pharmaceutical Companies.

. Quality Assurance/ Quality Engineering Supervisor,

Coordination of QA, Manufacturing and Laboratory Activities,

SOP Development, Approval & Implementation, Computer Systems

& Part 11, Equipment and Facilities Validations. In addition

510K preps, NDA, ANDA, CMC, and other Regulatory Submissions.

All types of investigations including CAPA, Root Cause and

others.

. Quality Auditing and Quality Systems Analysis / FDA Training

/ Industry training / ASQC Enrolled, FDA candidate for Team

Biologics.

. Extensive Experience Installation, Validation, and Evaluation

of Analytical and Process Instruments, as well as analytical

methods, applications development and research activities.

. Personal - Self Directed, Goal Oriented, Analytical and

Effective Problem Solving Abilities.

. Process and Analytical Instruments Management, Business

Development, Sales, Product Development and Marketing

-Training and Experience 17 yrs. / Emerson Electric, Fisher-

Rosemount Analytical Div., Tekmar-Dohrmann Instruments,

Hewlett-Packard Instruments, Sargent- Welch / Pye Unicam

Div./ Phillips N.A.

. Excellent Educational Background including research in basic

sciences(Rutgers Univ.) and medical oriented

sciences(Jefferson Medical College), Very Diversified General

Background, including electronic training, tool and die

apprenticeship, mechanical training and manufacturing

background (ISO 9000).

. Worked as a consultant for the last ten years for many major

consulting firms and also as an independent contractor for

myself (1099).

. During that time, performed a variety of duties worldwide in

validation, quality assurance, auditing and compliance for

biotech, pharmaceutical and medical device manufacturers.

. Have an extremely diversified background and skill set in the

areas of Pharmaceutical / Biotech manufacturing, Medical

Device manufacturing, and analytical instrumentation for

laboratory and process applications.

EDUCATION:

B.S. Degree in Biology Major, Chemistry Minor, Honors in Biology.

Rutgers University, New Brunswick, NJ, Five Publications

PhD Program in Developmental Neuro Embryology.

Thomas Jefferson University, Department of Anatomy/Jefferson Medical

School, Philadelphia, PA.

Full First Two Years of Medical School Course Work as Graduate

student

Research Activity, Three Publications.

Business Courses in MBA and Accounting.

University of Pennsylvania and Rider University

Graduate Courses in Biology. And Other Training

Rutgers University, Cell and Tissue Culture, Cell Bio, Cell Ultra

Structure,

TECHNICAL SKILLS:

Auditing: I typically will perform audits for all Medical

Device, Pharmaceutical and BioTech Facilities as required per

contract. Most short audits are not listed on my resume because

of space considerations and run 2-7 days. In the last six

months, I have audited for Cardinal Health, Wyeth, Response

Genetics, and Ambu. Two of these audits were computer

infrastructure audits, for a software manufacture and server

farm audits.

Pharmaceutical: GMP, ICH, ISO, OECD, Auditing, Validation, Solid

Dose, Parenterals, Sterile Fill, Pharmaceutical Manufacturing

and Auditing, Medical Device Manufacturing and Auditing: GMP

Compliance, QC/QA & Quality System Design and Implementation, QA

Analysis, Gap Analysis, Risk Analysis, HACCP Analysis and

Implementation.

Regulator Affairs: FDA Applications Such as: NDA, ANDA, 510K,

PMA, CMC, yearly updates, Other Regulatory Submissions & Issues,

excellent knowledge of requirements for regulator submissions.

Medical Device: FDA inspections, QSR, Medical Device

Manufacturing and Auditing, FEMA, CAPA, HACCP Analysis, Design

inspections, Packaging.

Biotech and Pharmaceutical:

Most Manufacturing Equipment: Fermentors, Chromatography,

Lyophilization, Autoclaves, Calibration, Analytical Instruments.

All Process Instruments and Controls: Computer Software, CIP,

Equipment and Systems, IQ, OQ, PQ, Experience in inspections

involving GLP, CLP, GCP, Analytical Instrumentation: UV, IR,

NIR, GC, GCMS, ICP, AA, HPLC, LCMS, and DNA sequencers. Process

Instrumentation: PLC, Scada, AOTF NIR, Mass Flow, and Analytic

Instruments.

Other Associated Areas: US Pharmacopia Liaison, Medical Device

Design, Sales and Management, Instrumentation Service/Repair,

Instrument Design, Marketing /Promotions, Technical Product

Knowledge, Computer Skills, Seminars / Technical Paper

Presentations, Training Seminars, Trade Shows / Logistics,

Research Lab Experience, Chemical Applications and Development

Experience, Formal Electronics Training, Tool and Die Maker.

Educational: Research and Phd Courses at Jefferson Medical

College in Pharmacology, Neuro-Biology, Toxicology,

Teratology,, Biochemistry, Structure & Function,

Electronmicroscopy, and Anatomy.

Present Project:

SQA Services

8/10 to Present: Johnson & Johnson, Consumer Products Div., Skillman, NJ,

Quality Systems Auditor, External & Internal

. Responsibilities: Performed outside audits for Johnson

and Johnson suppliers. Initiated CAPA, procedures,

compliance and follow-up activities. Utilized J & J

databases to monitor project management.

. Accomplishments: Have performed and completed audits

as part of FDA-requested J & J compliance. Completed

training, records and investigations.

CimQuest Vantage

10/09 to 8/10 STRYKER INSTRUMENTS, Kalamazoo, MI, Quality Systems Auditor,

External & Internal

. Responsibilities: Performed outside audits for Stryker

suppliers. Initiated CAPA, procedures and compliance and

follow-up activities. Utilized Stryker Trackwise,

Sharepoint, and Windchill databases to monitor project

management.

. Accomplishments: Completed many audits for critical

Stryker suppliers as part of FDA-requested Stryker

compliance. Completed training, records and

investigations.

5/09 to 9/09 MAC MEDICAL, Millstadt, IL, Auditor, Compliance Quality

Director, QSR set up

. Responsibilities: Developed, wrote, indexed and

established ground up QSR System for small medical

device manufacturer, after FDA inspection (483).

. Accomplishments: Established and implemented Quality

System Requirements for small medical device

manufacturer. Wrote and established 20 GMP Control areas

from CAPA to computer systems and document control

systems. Trained personnel and implemented many GMP

areas SOP for control of Quality System.

Validation Inc.

6/2008 to ORASURE TECHNOLOGIES, Bethlehem, PA., Cleaning

Validation Specialist / Manager

4/2009

. Responsibilities: Wrote VMP, SOPs, and protocols

for cleaning validation of production lines used for

HIV and Hepatitis testing devices. Validated product

manufacturing and packaging operations. Reviewed,

developed, modified and corrected Cleaning Validation

methods for production, storage, and transfer

facilities to packaging areas. Developed CAPA related

efforts to enhance Cleaning Validation and Production

methods.

. Accomplishments: Completed Cleaning Validation

Protocols for (21) pieces of equipment for production

lines. Performed all phases of cleaning validations

for difficult consumer products production areas.

Included the preparation or clean hold time protocol,

SOPs, analysis documents, performed validations and

assembled testing results and reports. Completed

documentation for cleaning validation and

presentation in 510K.

3/2008 to JOHNSON & JOHNSONS / MCNEIL, Lititz, PA., Cleaning Validation

Specialist for New Manufacturing Installation at Site.

6/2008

. Responsibilities: Performed and validated cleaning for

consumer products manufacturing and packaging operations

transferred to Lititz from Parsippany, NJ. Reviewed,

developed, modified and corrected CIP and Cleaning

Validation methods for production, storage, and transfer

facilities to packaging areas.

. Accomplishments: Completed Cleaning (CIP) Validations for

(17) 10,000 Kg. tanks on three production lines. Performed

all phases of cleaning validations for difficult consumer

products production areas as per rapid and rigid timeline

for completion, established by customer. Developed CAPA

related efforts to enhance Cleaning Validation and

Production methods. In addition preparation or SOPs, gap

analysis documents, performed validations and assembled

testing results. All products required re-validation per

FDA at new product site.

9/2007 to NOVARTIS PHARMACEUTICAL, East Hanover, NJ, Validation / IT

Quality Remediation

12/2007 Project,

. Responsibilities: Review, IT infra structure documents,

write and perform validation/qualification protocols for

IT Infrastructure and support services across US LAN

System for all business units. Upgrade the Master

Validation Plan, Site Master Plan to reflect current

Novartis IT status and methods.

. Accomplishments: Prepared gap analysis documents,

performed /Qualifications/ Validations and assembled

testing results. Upgraded SMP, LAN Qual. and all LAN

support departments SOPs and IOQs.

1/2008 to

3/2008 ACTAVIS PHARMACEUTICALS, Elizabeth, NJ, Validation /

Commissioning Engineering

. Responsibilities: Commissoning and Validation for new

production suites for Actavis. Suites included Glatt Fluid

Bed Dryer, USP water, solvent addition, AHU, chillers and

all other utilities.

. Accomplishments: Executed commissioning and validation

documents for Glatt Fluid Bed. Prepared checklists and gap

analysis documents, performed /Qualifications/ Validations

and assembled testing results.

2/2005 to

9/2007: SELF EMPLOYED CONSULTANT/CONTRACTOR, 1099

Sr. Consultant, Auditing, Validation and Compliance

CONTRACT POSITIONS BELOW:

. Responsibilities: Performed outside audits for Stryker

suppliers. Initiated CAPA, procedures and compliance and

follow-up activities. Utilized Stryker Trakwise,

Sharepoint, and Windchill databases to monitor project

management.

. Accomplishments: Completed over a dozen audits as part

of FDA-requested Stryker compliance. Completed training,

records and investigations.

5/2007 to

7/2007 BECTON DICKINSON COMPANY, Baltimore, MD, Validation / Quality

Remediation Project

. Responsibilities: Write and perform validation

protocols for sterile and aseptic parts of the

manufacturing process for test kits. Upgrade the Master

Validation Protocol to reflect current status and methods.

. Accomplishments: Prepared analysis documents, performed

validations and assembled testing results. Upgraded MVP.

Incorporated CAPA findings and documents into new methods

and status for MVP.

4/2007 to

5/2007 CONFIDENTIAL AUDIT, CONSENT DECREE, Dallas, TX.

Performed initial consent decree audit as part of five person

team for generic pharmaceutical plant. (Customer requested

Confidentiality)

. Responsibilities: Perform GMP audit of all production

facilities and quality records for generic firm. Review,

evaluate and perform gap analysis of control functions and

identify areas of deviation from GMP control and

documentation. Provide formal reports as part of audit team.

. Accomplishments: Prepared analysis documents for audit of

facility, and gap analysis for facility to avoid FDA Consent

Decree.

8/2006 to

4/2007 BOSTON SCIENTIFIC CORP., Maple Grove, MN (Project for ITE /

Alverion /2006-2007), Quality Systems Auditor / Quality

Remediation Project (Trackwise, Sparta Systems)

. Responsibilities: Review, evaluate and perform gap analysis

of control, instructional, and training documentation for

GSC2 (Trackwise Systems) Complaint Handling System.

Remediation and review of 8,500 MDR records as part of

quality systems evaluation for FDA review. Perform training

and presentations as part of project. Review associated CAPAs

and CARs as part of quality system evaluation. Document in

Excel results and remediate MDR database from Trackwise

Files.

. Accomplishments: Prepared analysis documents for basis of

SIRs, and SOP modifications to GSC2 System for Quality

Systems upgrades. Reviewed and remediated 8,500 MDRs as part

of Horizon Project at BSC. Prepared training and

instructional materials and presented training to 40 person

department.

3/2006 to AMGEN, - Thousand Oaks, CA. (Project for ITE / Alverion

/2006-2007),

8/2006 Validation / Compliance / Risk Analysis Audit Methods and

Equipment

. Responsibilities: Review and evaluate validation requirements

for production facilities. Review and evaluate current

compliance requirements procedures for GXP and EU regulations

vs. cost and risk analysis. Review and evaluate Quality

Systems.

. Protocols evaluated included quality systems, production and

release testing protocols for all products.

. Accomplishments: Prepared reports for management business

assessment of costs and reductions for current compliance

methods. Incorporated Risk and Hazards involved with

compliance streamlining costs.

6/2005 to MEDIMMUNE, INC. - Frederick, MD

4/2006 Validation/Compliance Analytical Methods and Equipment (

Project for Darwin Partners Boston, MA)

. Responsibilities: Review and evaluate validation requirements

for transfer of production laboratories and audit current

testing methods protocols for compliance to the Frederick

Manufacturing site from company Analytical Dev. Labs and

outside contract labs.

. Protocols evaluated included raw materials testing and

release testing protocols for monoclonals.

. Accomplishments: Prepared method transfer protocols for 9

analytical methods. IQ/OQ validations for DNA sequencer,

polarimeter, HPLC methods for proteins and bio assay

equipment. Reviewed other methods and validation

documentation for compliance to MedImmune Quality Systems.

2/05 to CARDINAL HEALTH - Albuquerque, NM

6/2005 Commissioning / Validation Sterile Fill Line

. Responsibilities: Preparation of URS, FAT, commissioning and

validation protocols for new sterile fill line / new

construction for commercial repacker. Equipment included:

Steriline tunnel, ICOS closure washer, Federgari autoclave,

cappers, vial washers and fillers.

. Accomplishments: Supervisor for small group working on the

validation of the Steriline tunnel, ICOS closure washer, and

Federgari autoclave. Prepared and executed protocols

(Comm./IQ/OQ/PQ) for that equipment. Prepared URS and FATs

for PennTech Vial washers, and other equipment.

12/01 to IPS Direct Employee: Projects Below

02/05 Sr. Consultant, Validation and Compliance, IPS is a medium

size construction engineering firm, with a compliance and

validation dept.

. Various major pharmaceutical and biotech companies, Schering-

Plough API audit, Wyeth-Ayerst Consent Decree as GMP /

Quantic FDA Auditor Dec. 2001-June 2004, Eli Lilly Bldg. 105

Renovation Project, QC Auditor, May 2004-Sept.2004.

. Many other small projects as GMP consultant and auditor.

. Supervised validation and commissioning projects worldwide.

10/2004 to IPSEN / BIOMEASURE - Milford MA.

2/ 2005 Commissioning / Validation New BioTech Facility

. Validation and commissioning of new biotech facility, 79 GMP

Systems protocols for all equipment, utilities and

facilities, including chromatography, purification, and

process equipment.

6/2004 to ELI LILLY AND COMPANY - Indianapolis, IN

10/2004 Auditing / QA / Commissioning / Validation

. Major Renovation Insulin Production Facility (Bldg. 105)

. Complete redesign of Lilly's major insulin production

facility.

. Involved in QA / management oversite of all equipment,

utilities and facilities.

. Commissioning and Validation protocols for all Facilities and

Equipment, Freeze Dryers, Autoclaves, 64 Fume Hoods and all

other production, packaging and environmental equipment.

2000 to WYETH - Pearl River, NY, and four other locations.

2005 Consent Decree Verification Auditor- Auditing / Compliance

. On site AUDITOR - Compliance auditor of Wyeth Facilities as

part of FDA CD compliance.

. Project involved review and discussion of Wyeth planning for

cGMP corrections to GMP audit of all facilities. Validation

documentation, quality systems, SOPs and all development and

planning procedures.

. Reviewing and on-site-auditing for each of the response items

(Twenty-Five GMP areas) prepared for cGMP deficiencies at

Wyeth Facilities (continuing four year project).

. Oversite, approval of corrective actions and monitoring as

onsite auditor. Corrective action packages were reviewed,

reported, approved and then sent to FDA for review.

. Had overall responsibility to review all Root Cause and CAPA

documents associated with consent decree activity.

2000 to SHIRE LABORATORIES - Montreal & Quebec City, Canada

2001 & Process Validation Specialist- Auditing / Compliance /

Validation

2003 to 2004

. Audit, review, preparation, planning, validation,

commissioning and implementation of two full facilities for

Influenza vaccine production facilities.

2000 to CENTOCOR - Malvern, PA

2001 & Process Validation Specialist

2003 to 2004

. Validation preparation and implementation for process

validation areas for monoclonal antibody production and

purification such as: chromatography, purification, elution.

2003 to SCHWERING - PLOUGH - Manati, PR.

2004 Senior Compliance Specialist- Auditing / Compliance /

Validation

. Audit of the Maintenance and Calibration Department, for GMP

compliance and procedures.

. Audit and GMP mock inspection of two separate API facilities

at the site. Writing of audit requirements for sterile

packaging facility on site.

. Review of all CAPA documents relative to API facilities.

2000 to CENTOCOR - Springhouse, PA, Johnson & Johnson Company

2001 & Validation Specialist- Validation

2003 to 2004 Validation of process packaging equipment, encapsulator,

validation areas for monoclonal antibody

production and purification.

2001 to FMC BIOTECH FACILITY

2001 Process Validation Specialist- Validation / Audit /

Commissioning

. FMC Biotech Facility, Validations of process areas for

pharmaceutical excipients production. Preparation of

equipment and process validation Protocols.

11/99 to PHOENIX IMPERATIVE, INC. Direct Employee: Projects Below

12/01 Sr. Consultant, Validation and Compliance, Phoenix was a

medium size construction engineering firm, with a compliance and

validation dept.

. Consultant for various major pharmaceutical and biotech

companies.

. Preparation of validation protocols and compliance documents,

execution of protocols, engineering projects and all phases

of contract pharmaceutical work.

. Technology transfer, project management, design and

validation of facilities including: DOD Vaccine Stockpile

Evaluation Project 2001.

. Netherlands Project Centocor (J&J). Worked as project manager

for Beckon Dickson biotech transfer project.

2001 to BARD BIOTECH

2002 Process Validation Specialist-Validation / Compliance

. Validation of equipment used for production in biotech areas

of production and research facilities.

4/2001 to DOD, DEPARTMENT OF DEFENSE - Ft. Detrick, and Dynaport,

Frederick, MD.

11/2001 Production Auditor /Compliance / Release Evaluation and

Development

. DOD Vaccine Stockpile Evaluation Project

. Project involved investigation, review, analysis of

production, release, and testing methods, including safety

and efficacy of stockpiled vaccine products for all branches

of the US military.

. This included some 30-40 years of vaccine production records

for DOD.

. Recommendations and reporting of deficiencies and comparison

to current production and release methods for inventoried

products.

7/2000 to CENTOCOR, JOHNSON & JOHNSON - Leiden, Netherlands.

6/2001 Process Validation Specialist

. Validation preparation and implementation for critical "Gap

Analysis" process validation areas, chromatography,

purification, elution, etc., vital to "New facility" license

and commissioning for monoclonal antibody production and

purification.

. Worked with computer validation for chromography control

systems for facility

2000 LEE LABORATORIES, A BECTON DICKINSON COMPANY - Atlanta, GA.

Project Manager for Technology Transfer

. BioTech Product Transfer of diagnostic restriction

endonuclease.

. Project involved Management of timeline (accelerated),

Personnel supervision, Documentation control, Validation of

all process and production equipment: fermentation vessels,

chromatography systems, instrumentation and cleaning methods

involved in the transfer of Biotech product.

. Oversight and validation of new isolation facilities as part

of production development.

2000 SCHWERING - PLOUGH - Kenilworth and Union, NJ

Senior Validation Specialist

. Validation of low temperature storage warehouses, computer

controlers and facilities for Interferon, monoclonal and

BioTech Products. Evaluation, redesign and verification of

monitoring and control systems for these storage areas.

. Storage facilities contained over $100 M in products.

Compliance work on logistics and shipping activities for low

temp storage products for cGMP compliance.

. Preparation of CAPA Documents for storage and handling

facilities related to renovation and control of monoclonal

storage areas.

DIRECT EMPLOYEE POSITIONS / Not Consultant:

10/97 to IMPAX LABORATORIES

11/99 QA Manager & Engineering Coordinator

. Manager of four person department answering to the QA/QC

Director. Responsiblities included: Validations, QA Audits of

the Facility & Laboratory, Regulatory Submissions, Annuals,

CMC Sectionals and Supplements. Hired as laboratory

troubleshooter by former FDA drug expert who was VP of

Quality at the firm.

. Investigated and prepared CAPA documents for site upgrades.

. Validations of Process, Product, Cleaning, Equipment,

Packaging, Computers and Instrumentation for Generic Drug

Firm. Also, served as QA/QE Engineering Coordinator -

Process Control of major systems for the manufacturing area:

Purified Water, Waste, Stability Chambers and Environmental

Systems, Supervision of QE personnel. Regulatory Submissions,

Annuals and Supplements, CMCs

10/93 to US FOOD AND DRUG ADMINISTRATION

10/97 Investigator

. Inspections of Pharmaceutical and Medical Device

Manufacturers for Compliance with US Food and Drug Act, cGMP

and QSR Regulations.

. Inspections of Commercial Sterility Companies using Gamma and

ETOX Sterilization, and Food Inspections (Cocoa Expert),

Candidate Team Biologics, assisted in HACCP inspections.

04/88 to TEKMAR-DOHRMANN INSTRUMENTS DIV, / FISHER-ROSEMOUNT CORP.,

10/93 DIV. EMERSON ELECTRIC CORP.

Analytical Instrument Sales Representative

. Responsible for Sales of GC/GC-MS accessories for Purge &

Trap, Thermal Desorption, Headspace Analysis, Elementary

Analyzers including: Total Organic Carbon, NIR Systems, Total

Organic Halogen, Nitrogen and Microcoulometric titration

systems and specific process instrumentation.

06/84 to HEWLETT-PACKARD INSTRUMENT DIV.

04/88 Analytical Instrument Sales Rep

. Responsible for Sales of GC/GC-MS, HPLC systems, UV Vis

products to pharmaceutical, research, manufacturing and

educational institutions.

06/77 to SARGENT-WELCH SCIENTIFIC COMPANY

06/84 Analytical Instrument Sales

. Pye-Unicam Div. / Phillips, N.A. Analytical Instruments

including AA, IR, UV/VIS, HPLC, and GC.

. Electrochemical / Polarographic Instruments including

titrators.

. Special Account Representative: Princeton University, Mobil

Oil Corp., Squibb and FMC Corp.

. Responsible for sales of analytical instruments and

scientific equipment to pharmaceutical, research,

manufacturing and educational institutions.

US FDA TRAINING:

. CSO Training Program, FDA Law

. Quality Auditing Course

. FDA Drug School and Advanced Drug School.

. Quality Auditing Program

. Medical Device Certification Program Enrolled.

. Basic Medical Devices Course.

. FDA Law School.

. Basic Investigator School.

. Part 11 Training

. Software Auditing Course

. QSR Training

. Registered Medical Device Investigator Training

. Many Other Training Courses

OTHER TRAINING:

. PDA, CTA, ASQC. IVH, and other training courses covering

many aspects of QC, audits, validation and systems training.

Resume Frederick J.

Gass

Employment History, Education, and Experience

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