ORC Expert Advisory Services ORC International

  home    |    find an expert    |    request an expert    |    join our network    |    about us     expert login  
Expert Consulting and Expert Witness Services
  search tips 
Share this page:  Send to LinkedIn Send to Facebook Tweet This Email Print

 Expert  729259

Expert in Pharmaceutical QC, Contamination Control, Aseptic Processing, Nonsterile Manufacturing

Available for your Consulting and Expert Witness Needs

New York (NY)
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

Expert earned his B.S. in Genetics from the University of California at Davis, and his Masters and Ph.D. in Microbiology from the University of Rochester (Rochester, NY). After an NIH postdoctoral fellowship at the Medical College of Virginia (Richmond, VA), he went to work for Bausch and Lomb (Rochester, NY) until 1994 when he accepted a position at Alcon Laboratories (Fort Worth, TX). He left Alcon Laboratories in 2004 as a Director in the R&D division to accept a position as Pharma Consultant (Microbiology) with Vectech Pharmaceutical Consultants, Inc which he left in 2009 as Sr. Director, Microbiology Services. He is currently employed as a successful consultant and trainer.

Expert is the Principal of Microbiology Network, Inc a company he started in 1996 as a means to encourage training and communications within the microbiological community. He is a recognized consultant and trainer with emphasis in GMP, investigations, Environmental Monitoring and contamination control (both Aseptic manufacturing and non-sterile production facilities) and microbiology laboratory audits and operations. The Microbiology Network supplies consulting, training, webinars and Email discussion groups (PMFList, PSDGList and C-CEList) He is an active author and speaker for the industry, support PDA and have served with the USP Analytical Microbiology Committee of Experts since 1993.

He has assisted companies as varied as start-ups, generics, and established pharmaceutical innovators with laboratory management and compliance issues, process change opportunities, project management, aseptic facilities start-up, investigations, implementation of rapid microbiological methodologies, and sterility assurance issues.


applied microbiology


bio-clean room


industrial microbiology


microbial contamination


microbial contamination detection


microbiology laboratory


pharmaceutical quality control

Show Secondary and Basic Areas of Expertise
Expert may consult nationally and internationally, and is also local to the following cities: Buffalo, New York;  Rochester, New York;  Syracuse, New York;  and Niagara Falls, New York.

Year   Degree   Subject   Institution  
1987   Ph.D.   Microbiology   University of Rochester, Rochester, NY  
1984   M.S.   Microbiology   University of Rochester, Rochester, NY  
1978   B.S.   Genetics   University of California, Davis  

Work History:
Years   Employer   Department   Title   Responsibilities

2009 to







He is an independent consultant who also operates a network of allied consultants available for a range of projects in the healthcare and personal products manufacturing industries.

2006 to 2009


Vectech Pharmaceutical Consultants


Microbiology Support


Senior Director


Responsible for microbiology caliber of consultations handled by Vectech. Active consultant with demand from pharmaceutical, personal product and medical device industries. Active in client validation of alternate (rapid) microbiological methods (RMM).

1994 to 2004


Alcon Laboratories






Responsible for microbiological aspects of product development, CMC submissions and technology transfers. Rapid microbiological methods. Budgetary responsibilities

1987 to 1994


Bausch & Lomb,Inc.






Primary responsibility for research lab evaluating new antimicrobial compounds for use as disinfectants. Budgetary responsibilities.

Career Accomplishments:


Professional Appointments

Vice-chair USP Microbiology Subcommittee 2000-2005, 2005-2010.


PDA Distinguished Author 2008.

Medical/Professional Internships

NIH Postdoctoral Fellowship.

Publications and Patents Summary

He has over 50 articles, has authored one book and edited a second - both on topics of industrial microbiology.

Selected Publications and Publishers  
 - Journal of Validation Technology  
 - PDA/DHI Publishers  
 - Pharmaceutical Technology Magazine  
 - PDA Journal of Pharmaceutical Science and Technology  
 - PDA/DHI Publishers  

Consulting Services:
Selected Consulting Examples:
  • A company presented a process that had been developed in the 1960s that used a highly contaminated material as the initial raw material. This raw material (and it's large microbial load) was then pooled and treated with a toxic antimicrobial to reduce the bioburden before processing. The project involved developing a regulatory strategy to allow reduction or removal of the toxic compound from the approved process as disposal costs for the spent material was a significant component of the unit cost. Expert worked with corporate Regulatory Affairs on the strategy, and then collected the requisite data (this required a year's worth of data by internal expectations). The actual project required management of project tasks, evaluation of the microbiological data - both bioburden and identification, and design/review of laboratory scale models against the manufacturing process. An alternate method was qualified using temperature rather than chemicals to maintain bioburden control which resulted in significant reduction in unit production cost. This process change was approved by the relevant national regulatory agency and is currently implemented.
  • A company was building an aseptic manufacturing facility and was having a great deal of trouble with the microbiology laboratory and the testing performed in support of the aseptic EM program. Upon review, there were several procedural issues that required attention in the lab. This developed to the point where the lab was redesigned to provide greater separation of clean and dirty operations and several validation studies that were questionable. After purchase of more appropriate lab equipment in some cases, revision of procedures and retraining in others, persistent "bioburden" issues were resolved and the lab began functioning efficiently, providing dependable data. This allowed identification of several true problems in the aseptic facility which were eventually corrected resulting in the successful qualification of the facility for aseptic production.
  • A company brought him in as part of a facility qualification project, but needed training on GMP with a focus on contamination control. In working with Manufacturing/Operations, Regulatory Affairs and Quality Assurance he developed a three-day GMP course that was conducted over a three week period to great success.
  • A company was a contract testing laboratory who needed annual GMP training to fulfill GMP requirements. In working with the company he developed a half-day course based on 483 observations and warning letters to underscore the different aspects of the microbiology lab GMP requirements. The course was successful, and the next year it focused on lab audit criteria with the following year focusing on specific considerations in 21 CFR 211 of interest to the microbiology lab. This annual training program is now a popular one for several labs.
  • A law firm needed assistance with defense against a charge of patent infringement for a particular sterile product. The assistance required broad technical background in the pharmaceutical industry with specific expertise in FDA's GMP requirements and the information provided in USP.
Recent Client Requests:
  • Expert for consulting on Evaluation of contract medical device manufacturer.
  • Expert for consulting on aseptic review.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Expert Witness Experience Summary:
He has participated in three cases as of end of 2010. Two of these ended prior to trial, after preparation of expert reports and depositions. One still underway. Expert testimony looked to GMP, contamination control, compendial requirements, sterility assurance, Quality Control (QC) microbiology and lab operations and testing.
Recent Litigation Client Requests:
  • Expert drug contamination for consulting on Sprinkler discharge affecting pharmacopieal facility.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

International Experience:
Years   Country / Region   Summary
2008 to 2008   Switzerland   Company XXX, was concerned about preparation for an regulatory audit. In preparation for this visit they supplied procedures and validation studies which allowed preparation prior to the on-site visit. During the on-site audit there was opportunity to train technicians in audit protocol as well as to identify several areas of potential improvement for the QC microbiology lab, the sanitization and Environmental Monitoring program, and the manufacturing operators. The facility passed its audit.
2008 to 2008   Italy   Company XXX, was concerned about preparation for an pre-approval inspection audit gy FDA audit. In preparation for this visit they brought expert and several other consultants over to evaluate the CMC section of the submission and audit their facility for GMP compliance. Significant deviations were observed, and solutions recommended for evaluation.
to   Western Europe   Frequently invited speaker to conferences and training sessions. Recent events have occurred in Budapest, England, Ireland, Copenhagen, Amsterdam, Munich, Strasburg, Brussels

Language Skills:
Foreign Language   Description
English   He is a native speaker

Market Research:
He has been involved with the US Pharmacopeia in a volunteer capacity since 1993. This perspective affords a broad perspective on QC issues, FDA enforcement activities and regulatory trends for contamination control of manufacturing and finished dosage forms. He is active in professional societies, and operates Email discussion groups (PMFList, PSDGList, C-CEList) that are the recognized standards for communication within the industry.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:

Too many to list independently. These focus on GMP, QC procedures, aseptic processing, non-sterile QC of products, bioburden control, aseptic manufacture, QC microbiology and compendial issues in the pharmaceutical, OTC, personal product and medical device industries.

Supplier and Vendor Location and Selection

Extensive. The process begins with preparation of a clearly written "User Requirements Document" which then drives identification of suitable equipment and directs the qualification program once that equipment has been identified.

Other Skills and Services

Training via webinar or in-house presentations.


Need the right expert?  We can help!

home       find an expert       request an expert       join our network       about us

Intota is now ORC Expert Advisory Services