David A. Porter Consulting
[Consultation Services, Resume, Publications, and Presentations are described in detail below]
Common Concerns
- Do you find yourself facing an audit by a regulatory agency?
- Are you certain that you have validated/verified compendial-related procedures?
- Are you sure you have performed the validation of your alternative methods with correct statistics?
- Is you GLP laboratory fully compliant?
- Do you find yourself in need of a custom training program, but you don't have a training department at your company?
- Have you encountered strange results/problems of a microbiological nature?
- Are your laboratory SOPs as good as they can be?
- Do you find yourself in a constant state of firefighting instead of productive research and development?
- Do you feel as though you are part of a fully interactive team, or does your company behave as though you are in your individual departmental silos?
If any of the concerns above apply to you and your company, David Porter may be able to help. He has been involved in achieving successful resolutions to each of the issues raised above.
If you would like to contact David Porter regarding possible consultation about any of the issues, please click the link below.
Consultation Services
Dr. Porter is at heart an educator. At one time, he was a certified public school teacher, and taught for two years before returning to school to earn his Ph.D.
He has employed his educator nature throughout all of his industrial work and on into his consulting career. What this means to those he works with is:
- He strives not merely to impart knowledge, but to teach others how to teach themselves
- He uses any of a number of approaches, separately or in combination, to accomplish the teaching goals
- He treats each person with respect, because we can also serve as each other's teachers and students
- He views learning as a cooperative venture, with two-way information exchange between student and teacher essential
- He accomplishes his teaching goals efficiently with both the student's goals and the student's institutional goals in mind
What this all translates to is regardless of the issue at hand, those he works with will come to better understand how to resolve their current issue, how to deal with similar issues, and how to teach themselves more effectively in the future. This will translate into better trained individuals who will also work better as team members because the interactiveness of the learning process will be emphasized through word and deed.
Summary of Qualifications
Proven change agent and leader in technical
problem solving with over 18 years experience in compendial
activities, medical device, consumer product and pharmaceutical
industry research, development and management.
Combining a broad technical background in life sciences,
biostatistics, and computer acumen, with an innate ability to
recognize and develop strengths in people, I help develop and
strengthen individuals and organizations.
Professional Experience
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Pre-regulatory inspection audits
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Microbiological trouble shooting
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GMP/compendial compliance audits
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Statistical analysis
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Training material development and presentation
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For all of my clients, I have brought my education-based approach into play. I do not consider myself to be the font of all knowledge. Rather, I believe that by working with the client together we will arrive at the resolution of your issue(s).
Director General Policies
and Requirements Division -
- As Director of the General Policies and Requirements division at USP, I oversaw the activities of 9 scientific liaisons responsible for 10 Expert Committees. These committees were in turn responsible for the vast majority of the general chapters within the USP/NF. There were also a number of monographs within the domain of some of the Expert Committees.
- As Director of the division, I was also responsible for the development of the divisional annual budget, tracking activities of all division members, giving presentations to numerous groups outside of USP, coauthoring journal articles and book chapters, setting up divisional meetings, report preparation, etc.
- I was the team leader for an interdepartmental team that developed a new process facilitating the generation of more general chapters at a faster rate with higher quality.
- I served as the Project Manager for the development of software that incorporated a large database and presented an attractive graphical user interface encompassing Information and Standards Development (ISD), Sales and Marketing, and Reference Standards information. The project entailed interaction with Information Technology, Sales and Marketing, ISD, and Reference Standards personnel. The database developed as part of this project served as the core database for a new infrastructure project (in which I also participated) that impacts the standards revision process. I was also a co-project manager for the development of a new electronic workflow system for use by the Drug Standards Division and the Publication group at USP.
- I served as an instructor in the USP Training program with emphasis on the development and teaching of courses related to microbiology/biology as related to the USP. I was the lead developer of the course content for the Fundamentals of Microbiology course. When requested, I also participate in the teaching of the introductory courses (USP 100 and 101). I also participated in the development of the course material for those two courses,
- My leadership experience includes the management of numerous industrial life science and biostatistics groups, including up to 25 individuals ranging from technical to senior scientist levels. I effectively developed individuals and teams within the various departments, and assured that the departmental financial aspects were well planned and tracked.\
- Trained in Total Quality Management, Targeted Management, Managing Quality Improvement, Team Dynamics, cGLP, cGMP, cGCP, ISO 9001. Served as an in-house ISO auditor, and performed outside GLP audits of contract facilities.
- Designed statistical protocols for numerous clinical studies as required for medical device studies. Protocols ensured that sample sizes were adequate, randomization assured, appropriate statistical methods included, and data properly collected and entered into the database. Wrote reports of clinical outcomes, and made presentations to both technical and non-technical people.
- Developed computerized databases (programmed in Java) for use in tracking activities related to USP Expert Committees and associated documentation.
- Created united department with uniform SOP's/systems from four pre-existing sections (in compliance with cGLP, ISO 9001).
- Participated on cross-functional
teams that successfully registered flagship products internationally
(
- Performed nonparametric analysis of historical clinical data leading to new claim for duration of skin moisturization for marketed product. Taught in-house regulatory people as to the basis of the statistical approach.
Manager of Biochemistry and Life
Sciences -
Manager, Microbiology, Toxicology, Biostatistics (separate groups) - Bausch & Lomb, Inc
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Restructured microbiology functions to coincide with the industrial organization’s changing strategic plans. Created uniform departmental SOP's/systems from four pre-existing sections (in compliance with cGLP, ISO 9001).
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Strengthened interaction/communication between the biology departments and all others within R&D and the divisional marketing groups for the industrial organization.
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Built and developed an industrial department that created and statistically validated a rapid, reproducible, high throughput multiparameter cytotoxicity test battery (3 new procedures published). Numerous products were developed, and technical issues resolved (pharmaceutical and medical device products) using these methods.
Education
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Post-doctoral fellow,
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Ph.D. Zoology,
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MS Biology,
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- Dabbah, R. and Porter, D.A. (2004). The role of USP in the Microbiological Assessment of Parenteral Manufacturing. In Microbial Contamination Control in Parenteral Manufacturing (Kevin L. Williams, Ed.), Marcel Dekker, Inc.
- Fivizzani, A.J. and Porter, D.A.
(1984). Seasonal
variation in the effect of thermal stimulation on reproduction in
two species of Fundulus.
In Chronobiology 1982-1983.
15th International Conference of the International
Society for Chronobiology
(E. Haus and H.F. Kabat, Eds.), S. Karger Publishers, Inc.
- Foster, D.N.,
Galehouse, D., Giordano, T., Min, B., Lamb, I.C., Porter,
D.A., Intehar, K.J. and Bacon, W.L.
(1992). Nucleotide sequence of the cDNA encoding the common
a subunit of the chicken pituitary glycoprotein
hormones. J. Mole.
Endocrinol. 8: 21-27.
- Gracia-Navarro, F., Gracia-Navarro
S., Porter, D.A. and Licht, P.
(1989). Immunocytochemical and ultrastructural study of the frog (Rana
pipiens) pars distalis with special reference to folliculo-stellate
cell function during in
vitro superfusion. Cell
and Tissue Res. 256: 623-630.
- Gracia-Navarro, F., Porter, D.,
Malag”n, MM and Licht, P. (1990).
Stereological study of gonadotropes in the frog Rana pipiens
after GnRH stimulation in vitro.
Cell and Tissue Res. 262: 171-176.
- Hamberger, J.F., Porter, D.A. and
Jessee, C.B. (1995).
Monitoring cellular metabolism in L929 mouse fibroblasts
using a D-Glucose consumption assay.
In Vit. Toxicol. 8: 239-246.
- Hamberger, J.F., Root, C.A and
Porter, D.A. (1992).
The relative toxicity of five common disinfecting/preserving
agents as determined by a modified neutral red dye release assay and
the agar overlay technique.
ICLC 19: 130-135.
- Licht, P, Khorrami-Yaghoobi, P. and
Porter, D.A. (1985). Effects of gonadectomy and steroid treatment on plasma gonadotropins
and the response of superfused pituitaries to gonadotropin releasing
hormone (GnRH) in the turtle Sternotherus odoratus.
Gen. Comp. Endocrinol. 60: 441-449.
- Licht, P. and Porter, D.A.
(1985). LH
secretion in response to gonadotropin releasing hormone (GnRH) by
superfused pituitaries from two species of turtles.
Gen. Comp. Endocrinol. 59: 442-448.
- Licht, P. and Porter, D.A.
(1985). In vivo
and in vitro responses to gonadotropin releasing hormone in the
turtle, Chrysemys picta, in relation to sex and reproductive stage.
Gen. Comp. Endocrinol. 60: 75-85.
- Licht, P. and Porter, D.A.
(1986). Role of
gonadotropin-releasing hormone in regulation of gonadotropin
secretion from amphibian and reptilian pituitaries.
In: Hormones and Reproduction in Fishes, Amphibians and
Reptiles (D. Norris and R.E. Jones, Eds.).
Plenum Press,
- Licht, P., Porter, D.A. and Millar,
R.P. (1987).
Specificity of amphibian and reptilian pituitaries for
various forms of gonadotropin-releasing hormones in vitro.
Gen. Comp. Endocrinol. 66: 248-255.
- Pappa, H., Porter, D.A., and Russo,
K.A. (2006).
Development of a New USP General Information Chapter:
Validation of Compendial Procedures.
Pharm. Tech. 30(3): 164-169.
- Porter, D.A. (1985). The effects of cycloheximide on in vitro response of Rana pipiens pituitaries to continuously superfused gonadotropin-releasing hormone. Biol. Reprod. 33: 393-400.
- Porter, D.A. (2007). Review of USP microbiology chapters. PDA Letter XLIII(2): pp 1, 13-16.
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- Porter, D.A. (co-inventor, Methods
for treating skin with 3-hydroxy benzoic acid and related
compositions.
- Porter, D.A. and Fivizzani, A.J.
(1983). Spontaneous occurrence of a synchronous hermaphrodite in the banded
killifish, Fundulus diaphanus (Lesueur).
J. Fish. Biol. 22: 671-675.
- Porter, D.A. and Licht, P.
(1985). Pituitary responsiveness to superfused GnRH in two species of ranid
frogs. Gen. Comp.
Endocrinol. 59: 308-315.
- Porter, D.A. and Licht, P.
(1986). Effects
of temperature and mode of delivery on responses to gonadotropin-releasing
hormone by superfused frog pituitaries.
Gen. Comp. Endocrinol. 63: 236-244.
- Porter, D.A. and Licht, P.
(1986). Dependence of GnRH action on Na+, K+, and Ca++
in the frog, Rana pipiens, pituitary.
J. Exp. Zool. 239: 379-391.
- Porter, D.A. and Licht, P. (1986). The cellular basis of the calcium dependence of GnRH-stimulated gonadotropin release from frog, Rana pipiens, pituitaries. J. Exp. Zool. 240: 353-361
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Porter, D.A., Sutton, S.V.W, Dabbah,
R. and Knapp, J.E. (2002).
Developing an
information chapter in the USP to demonstrate equivalency in
microbiological methods.
Amer. Pharm. Rev. 5(2): 14-19.
- Schepper-Vaughan, J. and Porter, D.A.
(1993). A new in
vitro method for assessing the potential toxicity of soft contact
lens care solutions. The CLAO Journal 19: 54-57.
- Sutton, S.V.W., Franco, R.J., Porter,
D.A., Mowrey-McKee, M.F.,
- Sutton, S.V.W., Kn
- Sutton, S.V.W. and Porter,
D.A. (2003). Development of the Antimicrobial Effectiveness Test
as USP Chapter <51>. PDA J. Sci. Tech. 56(6): 300-311.
- Sutton, S.V.W.
and Porter, D.A. (2007).
- Tirumalai, R. and Porter, D. (2005). Terminal Sterilization and Potential for Parametric Release. American Pharmaceutical Review 8(4): 26-31.
Oral Presentations
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Current Initiatives of the USP Analytical Microbiology
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Harmonization of Pharmacopeial Biotechnology Products Testing - AAPS, Denver 2001
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Current Initiatives of the USP Analytical Microbiology
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Current Initiatives of the USP Analytical Microbiology
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Equivalency of Microbiology Methods -
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Highlights of the May 2002 PDA/USP Joint Conference on Sterile Product Manufacturing -
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Highlights of the May 2002 PDA/USP Joint Conference on Sterile Product Manufacturing - PDA audioconference, 2002
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Sterility Assurance-The USP Perspective - American Association of Tissue Banks, 2002
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USP Standards for Biotech Drugs - National Association of Boards of Pharmacy, 2002
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Validation of Microbiological Methods - PDA meeting,
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Microbiological Controls: Compendial Tests and Harmonization - AAPS workshop, 2003
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Proposed USP Chapter <1072> “Disinfectants and Antiseptics” - DMPQ, 2003
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Regulatory and Pharmacopeial Issues for Rapid Microbiological Methods - A3P
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Validation of Alternative Microbiological Methods - Barnett meeting, 2003
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Validation of Microbiological Methods - RMUG, 2003
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Harmonization Status of Microbiology-Related Chapters -
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Method Validations. What Happens When It’s not Equivalent, and Concerns with Method Validations RMUG presentation, 2004
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Presentation for Microbiology Laboratory Controls Seminar addressing USP <1072. FDA, 2004
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Recent Initiatives of the USP Analytical Microbiology Expert Committee. Presentation for High Peaks Associates workshop, 2004
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USP Microbiology Update – January 2004. Elite Microsource Corporation,
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USP Microbiology Update – October 2004 - Presentation for Microrite course
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USP Microbiology Update - Microbiology Seminar, CDER, FDA, 2004
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USP Microbiology Update - Micro Users Group, Wyeth, (after dinner presentation), 2004
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Rapid Microbiological Methods - a USP Perspective - PDA-Milan, 2005
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USP Issues and Updates - NJPQCA, 2005
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Utility of Chapters <87> and <88> in USP 28 - PDA Forum, 2005
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