Quality Assurance Control

CARL MILLER

Phone 281-***-****

*************@*****.***

SPECIALIZED IN:

Systems Validation

Quality Assurance

GLP, GMP, and 21 CFR Part 11

Pharmaceutical Work Experience Schering-Plough

. Bioassay Laboratory Inc.

. Orpharm Inc.

. Animal Reference Laboratories

. Veterinary Analytical Laboratory

PROFESSIONAL EXPERIENCE:

Client: I T & E International April 2005 to Present

My current position is as a senior technical assessment auditor at Schering-

Plough International. In that position, it is my responsibility to review

and audit the validation in progress or completed for compliance with FDA

and corporate regulations. My primary responsibility is that of advisor

and trainer. I review validation in progress and then travel to the sites

to correct errors and train the validation personnel to prevent inspection

errors during an FDA audit or an internal QA/QC audit. I am also working

on developing the process for a Global System Inventory. This includes the

complete nomenclature and standardization of system naming and

identification

Client: I T & E International Feb 2003 to Mar

2005

My current position is as a senior validation consultant at Schering-

Plough in NJ, in the packaging and manufacturing equipment CSV (Computer

System Validation) Remediation Team. In that position, I review and

evaluate the legacy computer systems. This involves evaluation of the

complete formulation and dosage preparation for packaging. I review the

equipment used in the various areas of dosage formulation (aerosols,

tabletting, and liquid fill.). I also review the complete validation

process of all equipment used in the process including autoclaves,

solution sterilizers, and mixing equipment. In the tabletting section, I

review the tablet presses, coating, and packaging equipment. In the

liquid fill and aerosol sections, I reviewed the mixing tanks, piping,

filling units, capping units, labeling, and cartoning processes.

Client: Bioassay Laboratory Inc., Houston, TX Jul

2001 to Feb 2003

This company is a testing laboratory. The company does testing for

pharmaceutical manufacturers. They perform H.P.L.C. and LC/MS procedures

to determine the bioavailability and bio-equivalence. As the QAU (Quality

Assurance Unit), I inspect the analytical process and all phases of the

process up to completion and make a final report to management. I am also

responsible for teaching the GLP classes to all employees and the annual

company revue. The company is currently installing a LIMS system and I am

involved in validating the procedure. I am involved with the review and

validation of the LIMS system including the IQ, OQ and PQ. The LIMS

system requires the compliance with 21 CFR Part 11. I am currently

editing and updating all the company SOP's.

Orpharm Inc., Houston, TX Jan 1990 to Jul 2001

Since the company was in a startup position, all of the SOP's and

analytical methods had to be developed. I contributed to the development

and writing of each analytical method for quality control. I developed

methods for validation procedures. This included all the procedures for

the Lab Instrumentation G.L.C., H.P.L.C., I.R., optical rotation, melting

point procedure, and other miscellaneous wet chemistry procedures. In

addition to the Quality Control method development, I participated in the

documentation of production processes. I participated in writing the batch

sheets (the "how to" instructions for each process). As the processes

changed, I was involved in the correction and development of changes in the

process batch sheets. During the initial months of manufacturing, it was

required under GMP that each piece of equipment used in production be

validated and certified that it complied with the manufacturing process.

As Quality Control and Quality Assurance Director, it was my job to perform

these validations. I have been actively involved in the implementation,

documentation, certification, and inspection (by government agencies) of

the manufacturing of a Schedule II "API".

Mount Carmel High School, Houston, TX Jul 1992 to 1993

Position: Biology Teacher [This was done during a period of FDA review of

our initial NDA]

Animal Reference Laboratories Inc., Houston, TX

1987-1990

Animal Reference Laboratories, Inc. was merged with my own Veterinary

Analytical Laboratory in 1983. I returned in 1987 to act as the Technical

Director of the laboratory. As Technical Director, it was my

responsibility to insure that the technical employees performed their job

and that the quality of the results complied with standards set by the

American Veterinary Association. I was responsible for the Human

Resources of all of the technical personnel. I was also responsible for

the validating of the equipment before it was placed in operation. In

1988, we installed a laboratory information system. This system was

purchased from Computer Associates. I worked with the supplier to

interface all our equipment to the new system. In 1990, we changed to a

new system. This also required the interface with all the existing

equipment, some of which required a "black box device." I also reviewed

test results before being reported to the clients. I scheduled all of the

personnel. I dealt with the clients, resolving their problems and

concerns. The laboratory handled veterinary laboratory testing for all 50

states and some foreign countries.

Various Law Enforcement Agencies in the Harris County area

1979-1999

Position: Special Investigator Animal Cruelty Division Forensic

Specialist

Veterinary Analytical Laboratory, Houston, TX

1975-1983

In 1975, I started the first private veterinarian clinical laboratory in

the United States, specifically for the veterinary community of Houston.

I investigated the feasibility of setting up this type of laboratory. I

developed micro techniques because of the limited amount of blood supplied

by the veterinarians. I developed a set of normal values for

veterinarians unique to this region. In 1983, I elected to sell my

laboratory and return to school

Memorial Baptist Hospital, Houston, TX 1967-1972

Third Shift lab technician

I was the over night emergency lab technician performing hematology,

chemistries and Urinalysis plus blood bank procedures

Texas children's Hospital, Houston, tx

1972-1973

Third shift LAB TECHNICIAN

I was the over night emergency lab technician performing hematology,

chemistries and Urinalysis plus blood bank procedures

US army base hospital, Taipei - Taipei

1955-1958

As a dependent and having experience in clinical Lab work I worked as a

Lab assistant.

EDUCATION:

Masters Degree, University of Houston 1985 - 1987

Bachelor of Science, University of Houston 1974 - 1985

Associate of Science University of Houston, downtown 1967 -1971

MEMBERSHIP IN PROFESSIONAL ORGANIZATIONS:

American Society of Clinical Pathologists (CLA) (1954)

American Society of Quality

American Chemical Society

Texas Commission on Law Enforcement Officers Standards and Education

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