SPECIALIZING IN:

QUALITY: Auditing, CGMP/GLP Compliance, Systems, Technical Writing, Workflow Analysis, and Life-Cycle Validation [Design/Build/Operate/Evaluate/Maintain/Close]

CGMP-COMPLIANT CONTROL SYSTEMS: Define, Design, Construct, Equip, Staff, Train, Revise, Audit and Direct

METHODS, PROCESSES AND PRODUCTS: Define, Design, Develop, Deploy and Qualify

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AREAS OF EXPERTISE:

  1. Technical Documents: Dietary Substance and Supplement Issues, Mission Statements, Methods, SOPs, Formal Reports, Publications, Compendial Inquires, Letters to the FDA and the USP, DMFs, CMC documentation for NDAs and ANDAs, and Guidelines for GMPs for API as well as written responses to Agency Form 483 observations and other technical correspondence from the FDA.
  2. FDA Aware: Understand FDA's intent/bent/direction, and the reasons behind them, as well as aware of current FDA GMP enforcement approaches and initiatives. More...
  3. Quality Aware: An ASQC Trained Quality Auditor with an in-depth knowledge of, and understanding of, GMP, GLP, ISO 9000:2000, ISO 11001, ISO 17025, Taguchi target orientation toward quality, Simple Charting and SPC, and Validation. More...
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MISSION STATEMENT:

Our mission is to assist you in finding and implementing quality solutions that:

An experienced professional having broad analytical, facilities and systems, GMP, and management experience with a record of high-level responsibility and proven accomplishment in pharmaceuticals chemicals, and biocides. Analytical perspective, technically current, and results oriented. Key strengths:

Leader and manager of people, change, organizational units and projects from inception to completion to meet customer, quality, regulatory and business expectations.

Innovative scientist who finds or invents and develops cost-effective methodologies and procedures.

Problem solver/innovator with the ability to comprehend, and to successfully interpret, the complex interrelationships among customers, quality, regulations, processes, operations, and technologies.

Analytical chemist with excellent written and verbal skills as well as in-depth understanding of chemistry, pharmaceutics and all facets of the industry {CGMP; GLP; GAMP; ISO 9000; TQM; Commissioning; Qualification; Validation; mission, vision and values statements; general policies; standard operating procedures (SOPs); design, development and validation of test methods, equipment, processes, and supplies; scheduling; staffing and training; materials definition; methods; and systems management}.
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PROFESSIONAL EXPERIENCE:

FAME Systems, Lake Hiawatha, NJ 2001 - Present
CONSULTANT Details...

R & D Scientific Corporation, Flanders, NJ 2000 - 2001
VP of QUALITY MANAGEMENT Details...

Paul G. King Consulting, Lake Hiawatha, NJ 1995 - 2000
CONSULTANT Details...

Nutro Laboratories, Inc., South Plainfield, NJ 1995 - 1996
DIRECTOR OF QUALITY Details...

Sidmak Laboratories, Inc., East Hanover, NJ 1992 - 1994
DIRECTOR OF QUALITY CONTROL Details...

Biocraft Laboratories, Inc., Fair Lawn, NJ 1986 - 1992
DIRECTOR LABORATORY QUALITY ASSURANCE- 5.5+ years Details...

MANAGER OF QUALITY CONTROL LABORATORY - 0.5 year Details...

At-Sea Incineration, Parsippany, NJ 1985 - 1986
MANAGER OF LABORATORY OPERATIONS Details...

Berlex Laboratories, Cedar Knolls, NJ 1983 - 1984
SENIOR SCIENTIST Details...

BASF Wyandotte, Fairfield, NJ 1981 - 1983
SENIOR RESEARCH SCIENTIST Details...

American Cyanamid, West Windsor, NJ 1976 - 1981
RESEARCH SCIENTIST Details...

United States Army, Walter Reed General Hospital, Washington, DC 1969 - 1971
PHYSICAL SCIENCE ASSISTANT MOS: 01F20 Details...

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EDUCATION:

Postdoctoral Fellow and Assistant Professor at THE UNIVERSITY OF GEORGIA, Athens, GA where I worked for L. B. Rogers and helped develop an SCF system, an Enzyme Analysis System and improved the operation of a Laboratory Data Acquisition System.

Ph.D., ANALYTICAL CHEMISTRY, EMORY UNIVERSITY, Atlanta, GA. [In 1974, my dissertation, "The Automated Development of Analytical Methods", won Sigma Xi award for excellence.]

M. S., INORGANIC CHEMISTRY, EMORY UNIVERSITY, Atlanta, GA. [My 1969 thesis dealt with the synthesis of Tantalum (V) chloro-alkoxide coordination compounds containing β-di-ketone ligands.]

B.A., CHEMISTRY (ACS Certified), VANDERBILT UNIVERSITY, Nashville, TN, 1967.

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TECHNICAL TRAINING:

TECHNICAL DEGREE in Computer Programming and Systems Analysis. [A 1971 honor graduate from COMPUTER LEARNING CENTERS, INC., Rockville, MD.]

Technical Courses on:

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PROFESSIONAL AFFILIATIONS AND ACTIVITIES:

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DR. KING'S UNIVERSITY EDUCATION:

FROM September of 1974 until the end of 1975, Dr. King worked at THE UNIVERSITY OF GEORGIA in Athens, Georgia as a Graham Perdue Postdoctoral Fellow and Assistant Professor to Dr. L. B. (Buck) Rogers, Graham Perdue Professor. There he was, among other things, the System Manager, Systems Analyst, and Programmer for a Multi-User Hewlett Packard Minicomputer. Research efforts included the design and the construction of a computer-controlled system for constant-temperature (± 0.01 °C) comparative study of enzymatic reaction rates of immobilized enzymes to the rates using the soluble enzyme.

From mid-May of 1971 through: August of 1973, Dr. King attended EMORY UNIVERSITY in Atlanta, Georgia in a Ph.D. program under Dr. Stan Deming (who is currently at The University of Houston) that awarded him a Ph.D. in December of 1974 that was officially conferred upon him in June of 1975. Dr. King's major field of endeavor was Analytical Chemistry with minors in Inorganic Chemistry and Physical Chemistry. In Dr. King's Ph.D. program, he:

  1. Partially designed and then constructed, installed, debugged, and validated a full bi-directional parallel multiplexed external interface to a PDP-9 Minicomputer.
  2. Designed, constructed, installed, debugged, and validated a remote interface to PDP-9 for the robot, MADAM (Machine for the Automated Development of Analytical Methods).
  3. Designed and constructed the power systems, controls and critical components for MADAM.
  4. Debugged the operation of MADAM and validated that MADAM met or exceeded its hardware design specifications.
  5. Working from a version of FOCAL (a DEC interactive, interpretative language similar to BASIC) written for a PDP-15 (FOCAL.LAL), Dr. King researched this computer's machine language; dissected the core coding needed for his project; and generated his own version of FOCAL (FOCAL.PGK, version 1).
  6. Wrote, debugged, and validated key machine-code patches to his FOCAL.PGK (Version 1A) for the required data acquisition and control subroutines that provided real-time control and data acquisition capabilities for MADAM.
  7. Generated, programmed, debugged, and verified the performance of his own SIMPLEX direct-search algorithms that were used by the robot to adaptively search for an Optimum as defined by Dr. King.
  8. Selected a simple colorimetric analysis method for the determination of formaldehyde for his initial study; prepared the reagents needed by the robot, primed the eight (8) reagent delivery pumps and checked that the robotís component systems for acquisition (1) and system control (8) were operating as designed.
  9. Generated a simple optimum (Absorptivity of the colored reaction product); started the robot's search for the optimum greatest Absorptivity using EXPLEX, his modified SIMPLEX search algorithm; and monitored the performance of MADAM as the robot first found the region of optimum Absorptivity and then tracked it.
  10. Following mapping, he reviewed and verified all of the data and generated the appropriate reports.
  11. Then, selected a more complicated colorimetric test having more variables and repeated steps G through J.
  12. Finally, wrote his dissertation summarizing his research and findings, submitted the final document for review by the department, and defended his dissertation and findings in an open discussion that included faculty from all divisions of the Chemistry Department. [Note: In recognition of Dr. King's contribution to science in chemistry, automation, and process control, his copyrighted dissertation, Automated Development of Analytical Methods, (ADAM) received a SIGMA XI's annual award for scientific excellence.

From September of 1967 through April of 1969, Dr. King attended EMORY UNIVERSITY in Atlanta, Georgia in a Ph.D. program under Dr. Ronald C. Johnson that admitted him to Ph.D. candidacy and, in March 1969, awarded him an M.S. in Inorganic Chemistry. In Dr. King's original Ph.D. program, he:

  1. Studied Inorganic, Analytical, Physical and Organic Chemistry.
  2. Prepared, characterized and studied several novel Tantalum (V) chloro-alkoxide complexes with β-di-ketone ligands.
  3. Worked as a laboratory teaching assistant and tutor.
  4. Wrote his thesis on "The Coordination Chemistry of Tantalum (V)."

In addition, Dr. King holds an ACS Certified B.A. in Chemistry with a minor in Physics from Vanderbilt University, Nashville, Tennessee (awarded in June 1967).

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DR. KING'S ON-GOING TECHNICAL TRAINING:

  1. Dr. King is an ASQ-Trained Quality Auditor ([1995]), with competence certified by passing the formal ASQ written examination for Certified Quality Auditor.
  2. The numerous formal Technical Courses that Dr. King has successfully completed include:
    1. ASQ Certified Quality Manager Course (2001)
    2. 13th Annual ASQ Quality Management Conference (2001) including:
      1. Quality in a Lean Organization,
      2. Tools of Six Sigma,
      3. Navigating Your Organization Through the ISO 9000:2000 Transition,
      4. Using the Theory of Constraints to Resolve the Quality Dilemma,
      5. Using Quality Tools to Improve Performance Excellence in the Day-to-Day Operations, and
      6. Certification: The Next Step for Quality Managers
    3. 25th International GMP Conference and Aseptic Processing Tutorial (2001)
    4. How To Prepare For Your FDA Inspection: A Practical Approach (1999);
    5. FDA-sponsored training on 21 CFR 11 (1999);
    6. FDA Global Inspections (1998);
    7. Current FDA Views on Pharmaceutical Laboratory Operations and CGMPs (1998);
    8. Computer Validation & Aspects of Process and Equipment Validation (1997);
    9. Interfacing with the FDA (1997);
    10. Pre-Approval Inspection (1996);
    11. Quality Auditing (1995);
    12. Pharmaceutical Validation (1995);
    13. Software Audits (1993), TESTING COMPUTER SYSTEMS IN PHARMACEUTICAL APPLICATIONS, given by Confidence in Software. The 3-day course covered:
      1. FDA Requirements,
      2. Planning Validation,
      3. Validation Preparation,
      4. Testing Modules,
      5. Testing Interfaces,
      6. Challenging Functions,
      7. Challenging the System,
      8. Conducting the Challenge, and
      9. Acceptance Testing.
    14. Various Aspects of the Pharmaceutical Industry (1991);
    15. Quality Assurance for Laboratories (1989);
    16. Perkin-Elmer LIMS/CLAS System Management and Operation (1984) (Laboratory Information Management System [LIMS] and Computerized Laboratory Acquisition System [CLAS]);
    17. Laboratory Automation and Quality Control (1984);
    18. Personnel Supervision (1981); and
    19. General Management (1978).
  3. From September 1970 through March 1971, he studied:
    1. The formalized process by which software is defined, stated, written, debugged, tested and verified in a controlled documented manner,
    2. Programming in several IBM System 360 languages (including Basis Assembly Language [BAL], FORTRAN 66, COBOL, and PL/1), and
    3. The Fundamentals of Systems Analysis (including project planning, PERT charting, project auditing and review, and systems standards).
    4. In 1971, COMPUTER LEARNING CENTERS, INC. of Rockville, Maryland awarded him an honors diploma in Computer Programming and Systems Analysis. Dr. King went on to apply it when he completed his active duty military service in 1971 and returned to Emory University to successfully pursue his Ph.D.

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