Speaker Biographies

2008 PMF Workshop on Microbial Validation

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Robert Ferer

President, The Ferer Group, Inc.

Bob Ferer earned his Bachelor of Science in Engineering Chemistry from the State University of New York (SUNY) Stony Brook.  Having worked exclusively in the pharmaceutical and biopharmaceutical industry, Bob’s responsibilities have included analytical testing, validation study preparation and execution, quality assurance, operations management, facility layout and process planning; and turn-key project management (design, construction, procurement, start-up, qualification, and licensure).  Bob has over 19 years of experience in the industry, the majority working with Aseptic Manufacturing operations.  He has worked in all areas of manufacturing including formulation, component preparation / sterilizing, filling, inspection, labeling, and packaging.

The Ferer Group, Inc.
Collingwood
ON, L9Y 3Z2 Canada
(215) 896-5491
bob.ferer@theferergroup.com 

Courtland Imel

CEO, Ceutical Labs

Courtland Imel is CEO of Ceutical Laboratories, Inc.  Ceutical Laboratories, Inc. is a full service organization providing services to the pharmaceutical, medical device, dietary supplement, vet, and cosmetic industries.  Courtland has served as Director of Analytical Development, Quality Assurance, Quality Control, Document Control, Regulatory Affairs, Project Management, and Marketing for several major companies.  Courtland has 25 years experience in FDA regulated industries and 20 years in the medical device, pharmaceutical, cosmetic, food, and dietary supplement industries.  He has held key positions with M&M Mars, Allergan, Inc., ILEX Oncology, Aronex Pharmaceuticals, Mills Biopharmaceuticals, International Isotopes, Avail Medical Products, and Carrington Laboratories, Inc.

Ceutical Labs
3820 Burr Oak
Bedford, Texas 76021
+1 817-247-7513 
cimel@ceuticallabs.com

TC Soli, Ph.D.

Principal Consultant and President of Soli Pharma Solutions, Inc.

Dr. T. C. Soli, Principal Consultant and President of Soli Pharma Solutions, Inc. (SPS), has acquired considerable knowledge of pharmaceutical water systems through his 25 years of involvement with 5 pharmaceutical operating companies and career-long memberships on numerous industry-wide working committees related to water, including his current participation in the USP Pharmaceutical Water Expert Committee. 

His expertise also extends into all aspects of sterilization, aseptic and contamination control processes and the disciplines related to their quality control and testing, validation, and regulatory compliance.  During his career with operating companies, he has managed personnel and processes in various departments including microbiology and chemistry development laboratories, QC laboratories, regulatory affairs, project management, business development, and QA departments ranging from validation to complaint investigation. 

Using vacation time from his operating company jobs, Dr. Soli has been consulting part-time since 1995 for small and large pharmaceutical companies and related instrument manufacturers, and has served as an expert witness in two litigations.  He has also conducted numerous informational and training sessions related to pharmaceutical water microbiology and chemistry and written numerous articles and USP chapters, including the famous USP Informational Chapter <1231> Water for Pharmaceutical Purposes.  His consulting endeavors are now full time with SPS.

Soli Pharma Solutions
3520 Post Oak Road
Stokes, NC 27884
+1 (252) 795-4779
solipharmasol@earthlink.net

Scott Sutton, Ph.D.

Senior Director of Microbiologic Services, Vectech

Dr. Sutton earned his Masters and PhD in Microbiology from the University of Rochester (NY). With over 20 years of laboratory leadership experience in the microbiology arena of the pharmaceutical and personal products industries, he now consults through Vectech Pharmaceutical Consultants, Inc.  Clients have included startups, generics, established Fortune 500 companies, law firms and investment broker houses. Laboratory management, training, GMP, testing methodologies and microbiology-related project management are areas of special interest.  He has worked with the USP Microbiology Committee of Experts since 1993, serving as vice-chair since 2000.   He operates the Pharmaceutical Microbiology Forum with its monthly newsletter (http://www.microbiologyforum.org) and serves as a reviewer for several peer-reviewed journals.  Dr. Sutton also operates an information source on the internet – The Microbiology Network (http://www.microbiol.org) that provides services to microbiology related user’s groups.  This service also supports two Email lists, the first devoted to pharmaceutical microbiology (http://www.microbiol.org/pmflist.htm) and the second devoted to pharmaceutical stability (http://www.microbiol.org/psdglist.htm).