Dr. Sutton has over 25 years of experience in the GMP pharmaceutical, medical device, cosmetics and personal products industries with extensive publications and presentations. Consulting and training in Quality Assurance, GMP, contamination control, investigations of MDD (OOS), laboratory management and microbiology-related project management are areas of special interest. Clients have included startups, generics, established Fortune 500 companies, law firms and investment broker houses.
Most of our clients are interested in finding dependable consultants in CGMP, Quality Assurance, contamination control, cleanrooms, non-sterile manufacturing control of bioburden or microbiology laboratory operations (audit, design and review). The Microbiology Network was established in 1996 to improve compliance and science in the GMP regulated industries and focus on real-world, scientifically-based solutions to compliance issues.
Winner of the 2008 PDA Distinguished Author Award
Areas of Interest
- 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
Rapid Microbiological Methods
Journal of Validation Technology; Journal of GXP
- 6/09—present: responsible for a column on “Microbiology Topics” in each issue of these quarterly journals
The Microbiology Network, Inc., 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 [ link to Publications page ]
- Presentations [ link to Presentations page ]
- In-house Courses [ link to In-house courses ]
- 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
- 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
- 1/86—7/88: NIH Postdoctoral Fellowship under Dr. Francis Macrina in the Department of Microbiology
Ph.D., Microbiology, University of Rochester (1987)
- Advisor: Dr. Robert E. Marquis
- Thesis: Proton-translocating, Fluoride sensitive ATPases of Streptococcus mutans, Streptococcus sanguis, and Lactobacillus casei.
M.S., Microbiology, University of Rochester (1984)
B.S., Genetics, University of California at Davis (1978)