SUMMARY EXPERIENCE
Over thirty-five years hands on experience in Pharmaceutical, Device and Biologicals Manufacturing in the area of small and large volume injectables, sterile medical sets and devices, tablets and capsules, and home health care. Specific expertise in aseptic fill, terminal sterilization, validation, GMPs, quality systems, new product development, and pharmacy compounding. Created and renovated numerous quality systems to meet FDA requirements during consent decrees, and establishment of new manufacturing plants and new manufacturing lines.

CONSULTING EXPERIENCE EXAMPLES (1991-2000)
Unites States Surgical Corporation-manufacturer of surgical staples and surgical devices
Alcon Laboratories-manufacturer of ophthalmic solutions and devices
Lyphomed(Fugisawa Corp.)-manufacturer of generic and proprietary drugs
Puritan-Bennett-manufacturer of electronic monitoring devices
Telios Pharmaceuticals-manufacturer of wound healing systems
Novo Nordisk-world wide biotechnology company and major producer of insulin
Alza Corporation-pharmaceutical manufacturing corporation
Holister Stier Corporation- Small volume parenterals and biologicals
Centeon Corporation-biological manufacturing
Taylor/Acorn Pharmaceuticals-small volume parenteral contract manufacturer
Due diligence of small volume parenteral manufacturing plant for possible purchase by client
Due diligence of drug repackager in Russia for possible purchase by client
GMP audit of R&D organization of a medium size biotechnology company
Laboratory validation program for eye wash company

CONSULTING PROJECTS
-Rebuilt QA/QC system for medical devices
-Provided QA/QC input during consent decree and evaluated and provided summaries for
compliance issues. Evaluated validation system with proposed changes. Critiqued hundreds of
batch records with appropriate changes proposed.
-Trained QA/QC group in sterilization and GMP issues
-Rebuilt complaint system and product change and evaluation system for device manufacturer
-Responsible for validation of new large volume parenteral filling line for ophthalmic
manufacturer.
-Established QA/QC and validation system for several start-up corporations.
-Responsible for validation of aseptic filling line for international corporation.
-Auditing of laboratories, QA/QC systems and manufacturing facilities and systems.

EXPERIENCE

Biomedex (8/00 to 8/15/03)
-Responsible for creating the Quality System for a clinical injectable manufacturing and device
manufacturing company.
-Developed aseptic fill programs and parts cleaning and assembly programs for clients.
-Responsible for Quality Assurance, Quality Control, and Regulatory Compliance .
-Key technical liaison for customers and investors.
-Created FirstPharma, a compounding pharmacy

Lyphomed (1988-1991) VP of QA/QC
-Re-established FDA compliance and evaluated all ANDAs while under a consent decree.
-Standardized all QC operations between three manufacturing facilities.
-Managed a budget of 5-8 million dollars.
-Established a corporate QA group group for R&D new product evaluation and approval.
-Established a standard validation program for all facilities.

CONSULTING (1986-1988)

EXPERIENCE

Caremark, Inc.(1982-1986) Director level technical position
-Developed a patented aseptic fill manufacturing system for producing sterile customized TPN
solutions in nationwide pharmacies
-Responsible for a joint venture to produce sterile I.V. bags.
-Technical expert for the company in manufacturing, laboratories, quality control, and regulatory compliance.
-Developed and built a small R&D laboratory.
-Participated in sales growth of 4 million dollars to 180 million dollars during my four years of
employment.
-Responsible for 30 facilities nationwide. Director level position.

American McGaw Laboratories (1975-1982) Direct level QA/QC position
-Succeeeful in establishing FDA compliance at a large volume parenteral plant in Georgia after an
FDA initiated recall and shutdown.
-Relocated to Irvine, CA divisional headquarters to takeover and reorganize the divisional quality
assurance group.
-Responsible for for direct approval of all manufacturing , engineering, and R&D programs.

Abbott Laboratories (1968-1975)-Manager level QA/QC position
-Was one of the key individuals in a plant start-up effort after an FDA initiated recall and
shutdown .
- Was involved in new plant start-ups in Rocky Mount, N.C.,(LVPs and SVPs)Laurinburg,
N.C.(sterile disposable set manufacturer), and Alta Vista, VA(producer of sterile irrigating
solutions).
-Worked as QA troubleshooter for all Abbott divisions-hospital products, chemicals,
pharmaceutical products, and diagnostics.
Education
M.S. and B.S. in microbiology with a minor in chemistry. Have completed numerous courses in business and management. Have taught general microbiology, sterilization, and aseptic fill courses. Have given numerous papers at professional seminars.

Schedule of Fees for Expert #12394

Expert Designation Fee------------------$1000.00 (amount charged to use expert's name,applied
to case)
Retainer Policy-------------------------$4000.00 (applied toward last invoice)
Non-Testimonial-------------------------$300.00 per hour (Consulting and Analysis)
Testimonial-----------------------------$300.00 per hour (Deposition and in Court; Waiting to
Testify)
Travel Policy---------------------------$300.00 per hour for U.S.travel one way
Misc------------------------------------At cost and as needed