Dr. Sutton's Areas of Interest:

• cGMP

  • Manufacturing Issues

    • Aseptic Production

    • Environmental Monitoring of Controlled Environments

    • Non-sterile Manufacturing Operations

    • API Production

  • Laboratory Issues

    • Lab Practice vs Regulatory Expectations (International Guidances and FDA 483 observations)

    • Lab Audits

      • Preparation for regulatory audits

      • Qualification of external contract labs

      • Training exercises

    • Test Method Validation

• Laboratory Design and Leadership

  • Lab design review to minimize laboratory-induced OOS

  • SOP review and consultation

  • Lab Practices training

  • Management consultation on Best Practices and metrics to assure efficient operation

  • Training and proficiency documentation

• Project Management

• Rapid Microbiological Methods

• Expert Witness

• In-house training

Contact Scott Sutton for Consultation

Review White Papers on Topics of Interest

Details Below

Consultation Services Resume Publications Presentations In-house Courses

Also see our White Papers and the QC Microbiology Bibliography

Services

cGMP - Manufacturing

• Guidance and assistance in meeting the new requirements of FDA's Aseptic Processing Guidance.
• Consulting on manufacture of non-sterile product dosage forms and API with particular emphasis on the requirements of the newly harmonized Microbial Limits Tests.
• Consultation on modernizing, or on "greening" established API production processes.
• Assistance in responding effectively to FDA observations and warning letters.
• cGMP audits of facilities and associated control systems for both sterile and non-sterile finished dosage forms.
• Project management services.
• Process development for contamination control
• Sterilization sciences

Training

• Manufacturing Focus
  • GMP for Manufacturing
  •  Environmental Monitoring (both for sterile and non-sterile processes)
  • Aseptic Processing
  • Contamination Control
  • Microbiology for Aseptic Manufacturing
  • Microbiology for cosmetics and non-sterile manufacturing
  • What is the FDA and its role?
  • PAT and Rapid Microbiological Methods in Manufacturing Support
•  Microbiology Lab Focus
  • The United States Pharmacopeia & Microbiology
  • Auditing the Microbiology Lab (contract lab or QC support)
  • GMP for the QC Microbiology Lab (suitable for annual training requirement)
  • Understanding the USP Tests
  • Investigations of Microbiological Data Deviations (OOS)
  • USP Chapter <1117> Best Microbiological Lab Practices
  • Validation of Alternate Microbiological Methods

cGMP - Laboratory

• Design of microbial identification strategy to assist in investigations while maintaining operating expenses.
• Review of documentation and assistance in compliance.
• Management of change to establish and maintain a compliant laboratory culture.
• Design and evaluation of a SOP system to support compliance and training.
• Auditing of Pharmaceutical laboratories in preparation for regulatory inspections and also as an aid to benchmarking and training.
• Laboratory investigation support, e.g., sterility test failure and media fill failure investigations, evaluation of aseptic processing procedures
• Training on critical knowledge and skills brought to your site from recognized and experienced experts in the field. Courses can be developed to meet your needs, or can be chosen from a selection of prepared units including:
  • Microbiology and the USP
  • Validation of microbiological methods
  • Microbiology validation - theory and practice
  • Auditing a Microbiology Lab (and preparing for the audit)
  • Techniques in effective laboratory organization, leadership and management
• Project management services.

Lab Management

• Design of the laboratory to assist in workflow and efficiency
• Assistance in equipment acquisition, documentation and validation to maximize efficiency.
• Training in all aspects of microbiology in the pharmaceutical, medical device and consumer products industries.
• Optimization of laboratory operations and procedures.
• Development of environmental control procedures
• Quality engineering and quality management evaluation of your laboratory
• Laboratory automation.
• Project management services.

Project Management

• Assistance in developing project strategy for process change, product development where circumstances require significant microbiological expertise
• Assistance in technical documentation to support NDA/ANDA/CTD filing.
• Skilled manager in all aspects of microbiological testing to meet product development or process change needs.
• Assistance with regulatory submissions and interactions.
• Assistance in development of metrics to reflect laboratory operations

Rapid Microbiological Methods and PAT

• Application of Rapid Microbiological Methods to support manufacturing within the Process Analytical Technology Initiative.
• Recommendation and validation of appropriate alternate microbiological technology to maximize efficiency.
• Evaluation of your current manual growth-based systems with recommendations and implementation of a rapid system that suits your user requirements.
• Comprehensive Installation Qualification, Operational Qualification, and Performance Qualification validation protocols and execution, as well as process development and validation study services for the new rapid technology.

Expert Witness

• Aseptic manufacturing and environmental monitoring
• Microbiological control
• Product adulteration through contamination
• Contact Lens Care Products

Winner of the 2008 PDA Distinguished Author award

Contact Scott Sutton for Consultation

Consultation Services Resume Publications Presentations In-house Courses

Resume: Scott V.W. Sutton

Education:

• Ph.D. (microbiology) 1987 University of Rochester
  • Advisor: Dr. Robert E. Marquis
  • Thesis: Proton-translocating, Fluoride sensitive ATPases of Streptococcus mutans, Streptococcus sanguis, and Lactobacillus casei.
• M.S. (microbiology) 1984 University of Rochester; Rochester, NY
• B.S. (genetics) 1978 University of California at Davis

• The Microbiology Network, Inc. (http://www.microbiol.org) 2/95 to present

  • Independent Consultancy

  • Own, operate and maintain the Internet information service for microbiologists. This service provides information, links, mail lists, and web pages for individuals and user's groups in microbiology.

  • Own and Moderate the PMFList since 7/95 – an Email list devoted to pharmaceutical microbiology.

  • Own and Moderate the PSDGList since 9/2005 - an Email list devoted to pharmaceutical stability programs.

  • Publications
  • Presentations
  • In-house Courses

• The Pharmaceutical Microbiology Forum (http://www.microbiologyforum.org)

  • 5/05 – Present: President; Editor - PMF Newsletter; this newsletter designed to provide a source of information and training for the professional microbiologist in regulated industries.  Archives available at http://www.microbiologyforum.org/news.htm.

• Scientific Advisory Boards

  • Genomic Profiling Systems 4/02 – Present

  • MODA Technology Partners 12/06 – Present

• Editorial Boards

  • Controlled Environments Magazine 10/05 – Present

  • PDA Letter 12/05 – Present

  • PMF Newsletter 1/06 – Present

• Vectech Pharmaceutical Consultants
  • 3/06 - 11/09: Senior Director, Microbiology Services
  • 3/04 – 3/06: Pharma Consultant, Microbiology
    Recent Projects:
    • Many training programs for international pharmaceutical, medical device and personal products companies
    • Expert Witness for FDA in legal action involving a Medical Device Manufacturer
    • Redesign and re-equipped a microbiology laboratory to eliminate persistent contamination issues. Job involved training, rewriting the entire SOP system, re-hiring technicians and lab management, and facility redesign to optimize work-flow. This laboratory supported environmental monitoring for an aseptic manufacturing facility and conducted finished product testing.
    • Market review of available rapid microbiological methods with focus on consumer Return on Investment (ROI). Study conducted for vendor.
    • Laboratory review for start-up focusing on microbiology laboratory control and data integrity. Included training, SOP generation and benchmarking studies as well as input on product design.
    • Project management for changes to legacy API manufacturing process to "green" the process and eliminate costs associated with toxic preservative in raw material. Project planning, project management (coordination of work at three separate locations during the 12 month project) and regulatory submission.
    • Generation of technology benchmarking reports for microbiology in pharmaceutical and personal care industries.

• Alcon Laboratories, Inc., Fort Worth, TX

  • 3/01 – 3/04: Director, R&D Microbiology

  • 1/98 – 3/01: Associate Director of R&D Microbiology

  • 6/94 – 12/97: Assistant Director of R&D Microbiology

• Bausch & Lomb Research Center, Rochester, NY

  • 9/92 - 6/94: R&D Manager, Product Development Microbiology

  • 10/91 – 9/92: R&D Manager, Healthcare Products

  • 9/88-10/91: Senior Research Specialist; Lab Leader, Microbiology Research

• Monroe Community College, Rochester, NY

  • 1992 - 6/94: Adjunct Faculty, Dept. of Biology Taught course (lecture and lab) "Medical Microbiology for Nurses" for four semesters.

• Medical College of Virginia, Richmond, VA

  • NIH Postdoctoral Fellowship under Dr. Francis Macrina in the Department of Microbiology, 1/86 - 7/88.

• United States Pharmacopeia (USP)
  • 1993 - Named to advisory panel (Preservation Efficacy and Aseptic Processing) to Microbiology Subcommittee of USP
  • Elected to serve the 1995-2000 revision cycle on the USP Subcommittee of Revision, Microbiology
  • Elected Vice-chairman of the USP Committee of Experts, Analytical Microbiology, for the 2000-2005 revision cycle
  • Elected Vice-chairman of the USP Committee of Experts, Microbiology and Sterility Assurance, for the 2005-2010 revision cycle
  • Member Project Team 18 (PAT); Working Group 6 (Rapid Microbiology Methods) from 2003 to present
• Association for the Advancement of Medical Instrumentation (AAMI)
  • USP representative to the Association for the Advancement of Medical Instrumentation (AAMI) 1995-2000.
  • Alcon representative to WG 8-Microbiological Methods; and WG 4-Biological Indicators, from 1999 to 2004.
• Parenteral Drug Association (PDA)
  • Member of Task Force on “Microbiological Data Deviations”
  • Member of Task Force on “Validation of Alternate Microbiological Test Methods” 1998 – 2000 (completion)
  • Member of Task Force on “Isolator Technologies”
  • Served on Conference Planning Boards:
    • 1997 Annual Conference (3/97 in Philadephia, PA)
    • Basel 2000 Meeting (2/00 in Basel, Switzerland)
    • 2001 Spring Conference (3/01 in Las Vegas, NV)
    • 2009 PDA Microbiology Meeting (10/09 in Baltimore, MD)
  • Program Chair of “BSE/TSE Issues Forum” (December 5-6, 2001 in Washington, DC)
  • Faculty for TRI (Training Research Institute) 2004 to present
  • Editorial Board for PDA Newsletter 2006 to present
• American Society for Microbiology (ASM)
  • Board of Education and Training
    • Auditor/Reviewer for Workshops
    • Faculty and convener in national workshops 1990, 1992, 1994, 2004
  • Vice President of Central NY chapter 1991-1993
  • President of Central New York Chapter 1993-1994
  • Planning Committee, Texas Branch Fall Meeting, 1999

Consultation Services Resume Publications Presentations In-house Courses

Presentations not listed due to space considerations - over 300 presentations to international audiences to date.

Publications

1. Correlation of the Genetic Map and the Endonuclease Site Map of Bacillus subtilis Bacteriophage SPO2; with S. Graham, Y. Yoneda, and F.E. Young. Journal of Virology 42:131 134 1982.

2. Acid Tolerance, Proton Permeabilities, and Membrane ATPases of Oral Streptococci; with G.R. Bender and R.E. Marquis. Infection and Immunity 53:331 338 1986.

3. Membrane associated and Solubilized ATPases of Streptococcus mutans and Streptococcus sanguis; with R.E. Marquis. Journal of Dental Research 66:1095 1098 1987.

4. Fluoride Inhibition of Proton Translocating ATPases of Oral Bacteria; with Gary R. Bender and Robert E. Marquis. Infection and Immunity 55:2597-2603 1987.

5. A Spreadsheet for the Quantitative Validation of Direct Transfer Sterility Testing. Binary: Computers in Microbiology. 2:191-194. 1990.

6. Neutralization Efficacy of Dey-Engley Media in Testing of Contact Lens Disinfecting Solutions; with Thomas Wrzosek and David W. Proud. Journal of Applied Bacteriology 70:351-354. 1991.

7. D-value Determinations Are an Inappropriate Measure of Disinfecting Activity of Common Contact Lens Disinfecting Solutions; with R.J. Franco, M.F. Mowrey McKee, S.C. Busschaert, J. Hamberger, and D.W. Proud. Applied and Environmental Microbiology 57:2021-2026. 1991.

8. Ophthalmological Preparations; with T.M. Dolak, O.W. Lever, D. Marsh, and I. Moran. IN Ullman's Encyclopedia of Industrial Chemistry vol. A 18 VCH Publ, Germany. pp. 127-151 1991.

9. Development of a Universal Diluting Fluid for Membrane Filtration Sterility Testing; with David W. Proud. Applied and Environmental Microbiology. 58:1035-1038. 1992.

10. A Critical Evaluation of the Multi-item Microbial Challenge Test in Ophthalmic Disinfectant Testing; with D.W. Proud, H. Proskin and D.A. Keister. The CLAO Journal. 18:155-160. 1992.

11. The Importance of Neutralizer Evaluations in the Microbicidal Testing of Preservatives and Disinfecting Solutions. International Contact Lens Clinics. 19:167-173. 1992.

12. The Relation Between Oral Pain and Ethanol Concentration in Mouthrinses; with S.J. Bolanowski and G.A. Gerscheider. Journal of Periodontal Research 30:192-197. 1995.

13. Neutralizer Evaluations as Control Experiments for Biocidal Efficacy Tests IN Handbook of Disinfectants and Antiseptics, J.M. Ascenzi (ed.) Marcel Dekker, Inc., NY. pp. 43 - 62. 1996.

14. Antimicrobial Effects of Hydrogen Peroxide as an Antiseptic and Disinfectant; with Andrea Lance, IN Handbook of Disinfectants and Antiseptics, J.M. Ascenzi (ed.) Marcel Dekker, Inc., NY. pp159 - 176. 1996.

15. Preservative Efficacy, Microbial Content, and Disinfectant Testing; with Mary Anne Magee and Daniel K. Brannan, IN Cosmetic Microbiology, D.K. Brannan (ed.) Marcel Dekker, Inc., NY. 1997. p.95.

16. In-use Shelf-Life Testing – What Data are Required and When?; with Brian Matthews and Danny Dunn. Regulatory Affairs Journal 9:728-733. 1998.

17. Activities of the USP Microbiology Subcommittee of Revision During the 1995 – 2000 Revision Cycle; with Joseph E. Knapp and Roger Dabbah PDA Journal of Science and Technology 55(1):33-48. 2001

18. The Role of USP in the Assessment of Microbiological Quality of Pharmaceuticals: A Five-Year Retrospective Leading to the Future; with Roger Dabbah and Joseph E. Knapp Pharmaceutical Technology North America 25(7):54-61 2001

19. Review of Standard for Evaluating the Effectiveness of Contact Lens Disinfectants with Ruth A. Rosenthal and Barry A. Schlech. PDA Journal of Science and Technology 56(1):37-52. 2002

20. Developing an Information Chapter in the USP to Demonstrate Equivalency in Microbiological Methods with Joseph Knapp, Roger Dabbah and David Porter American Pharmaceutical Review 5(2):14-19 2002

21. Validation of Microbial Recovery from Disinfectants; with David W. Proud, Stephen Rachui, and Daniel K. Brannan PDA J of Science and Technology 56(5):255-266. 2002

22. Development of the Antimicrobial Effectiveness Test as USP Chapter <51>; with David Porter. PDA J of Science and Technology. 56(6):300-311. 2002

23. The USP Perspective to Minimize the Potential Risk of TSE-infectivity in Bovine-derived Articles Used in the Manufacture of Medical Products; with Ian DeVeau and Roger Dabbah. Pharmacopeial Forum. 30(5):1911-1921. 2004

24. Microbial Identification in the Pharmaceutical Industry; with Anthony Cundell. Pharmacopeial Forum. 30(5):1884-1894. 2004

25. Towards an Improved Sterility Test; with Jeanne Moldenhauer. PDA J of Science and Technology 58(6):284-286. 2004

26. Validation of Alternate Microbiology Methods for Product Testing - Quantitative and Qualitative Assays. Pharmaceutical Technology. 29(4):118-122 Jan/Feb 2005.

27. Activities of the USP Analytical Microbiology Committee of Experts During the 2000 - 2005 Revision Cycle; with Joseph E. Knapp and David Porter PDA Journal of Science and Technology 59(3):157-176. 2005.

28. Disinfectant Rotation – A Microbiologist’s View. Controlled Environments (formerly A2C2). 8(7):9-14. July, 2005

29. Cleanroom Microbiology. IN Environmental Monitoring: A Comprehensive Handbook - Volume 1, J Moldenhauer (ed.) DHI Publications, Washington, DC. pp 97-118. 2005

30. Opportunities for the Pharmaceutical Industry. IN Encyclopedia of Rapid Microbiological Methods - Volume 1, M. Miller (ed.) DHI Publications, Washington, DC. pp 123-156. 2005

31. Microbial Identification Systems; with J. Moldenhauer. IN Environmental Monitoring: A Comprehensive Handbook - Volume 2, J. Moldenhauer (ed.) DHI Publications, Washington, DC. pp 281-296. 2006

32. Preservative Efficacy Testing and Microbial Content Testing. IN Cosmetic Microbiology 2nd Ed, P. Geiss (ed.) Marcel Dekker, Inc., NY. pp. 111-145. 2006.

33. Compendial Requirements for Automated Microbiological Method Validation: The Role of USP Chapter <16> “Automated Methods of Analysis” and the Proposed Chapter <1058> “Analytical Instrument Qualification” with David Jones PDA Newsletter 42(6):23-26 2006.

34. Microbial Surface Monitoring; IN Environmental Monitoring Anne Marie Dixon (ed) Informa Healthcare. 2006.

35. The Harmonization of the Microbial Limits Tests; Pharmaceutical Technology 30(12):66-73 2006.

36. Is Real-Time-Release Through PAT Compatible with the Ideal of "Science-Based Regulation?” Pharmaceutical Technology 31(2):97-98. 2007

37. Disinfectant Rotation in a Cleaning/Disinfection Program for Clean Rooms and Controlled Environments; IN Disinfection and Decontamination: Principles, Applications and Related Issues Gurusamy Manivannan (ed) Taylor and Francis 2007.

38. Articles of Interest to the Microbiologist; PDA Letter 18(2):7-10.  2007

39. Compounding of Sterile Medications in the Pharmacy - USP Chapter <797> Provides Guidance with David Porter Controlled Environments 10(6):11-13.  2007

40. Pharmaceutical Quality Control Microbiology: A Guidebook to the Basics DHI Publishers, Inc.  2007 
    Awarded PDA's "Distinguished Author" for 2008

41. Microbiology and  the Internet IN Microbiology in Pharmaceutical Manifacturing 2nd Ed Richard Prince (ed)  DHI Publ  2008

42. Global Harmonization of Microbiology-Related Compendial Chapters IN Microbiology in Pharmaceutical Manufacturing 2nd Ed Richard Prince (ed)  DHI Publ  2008

43. USP <1211>: The Compendial Informational Chapter on Sterility Assurance - Origins and Future Direction Pharmaceutical Technology Ster Manufact Suppl:s16-s21   2009

44. Does International Harmonization of the USP Microbial Limits Tests Require Re-Validation of Finished Product Tests? J Val Technol  15(3):10-16.  2009

45. Hand Washing - A Critical Aspect of Personal Hygiene in Pharma J Val Technol 15(4):50-55.  2009

46. The International Harmonization of the Compendial Microbial Limits Tests- A Cautionary Tale of Compendial Participation J GXP Compliance 13(4):8-15  2009

47. Limiting Avoidable Microbiological Variability J Val Technol 16(1):50-56   2010

48. Hand Washing, Hygiene, CGMP and Science J GXP Compliance 14(1):62-69   2010

49. Qualification of an Environmental Monitoring Program J Val Technol 16(2):78-82   2010

50. The Importance of a Strong SOP System in the QC Microbiology Lab J GXP Compliance 14(2):44-52  2010

51. The Most Probable Number Method and Its Uses in Enumeration, Qualification and Validation J Val Technol 16(3): in press

52. Microbiology Laboratory Design:  Quality and Facility Considerations  published by DHI Press   in press

53. Sterility Testing; IN Pharmaceutical Dosage Forms: Parenteral Medications, Third Edition  Sandeep Nema and John D. Ludwig, (ed) in press

Consultation Services Resume Publications Presentations In-house Courses