“Mr. Guarnacci was successful in obtaining College of American Pathology (CAP) laboratory accreditation for the clinical laboratories supporting the upcoming HIV-1 phase III vaccine trial. This is the first and only CAP certified laboratory in Thailand and Southeast Asia! This was a major accomplishment requiring great initiative, incredible attention to detail, and well developed interpersonal skills.
I strongly recommend Mr. Guarnacci for any Clinical Quality Assurance or Regulatory Affairs endeavors requiring initiative, independence and competence.”
Carl J. Mason, MD, MPH
“During his tenure, Mr. Guarnacci supported the development and implementation of clinical quality assurance infrastructure which resulted in securing the first International College of American Pathologist accreditation of laboratories in Thailand in 2002.
His accomplishments required an intimate understanding of Thai cultural norms and Thai language skills; the ability to orchestrate activities between both the US and Thai components and a high level of regulatory competency.
I recommend Mr. Guarnacci to support any clinical quality assurance activities that require a complete understanding and ability to apply regulatory requirements and first hand knowledge of how to conduct clinical research in the Asia Pacific arena.”
Sorachai Nitayapan, MD, PhD
Deputy Director General, Royal Thai Army
“I have known Tobin since 2004, and have found him be a consummate Clinical Quality professional. He has effectively applied his skills and knowledge to resolve difficult problems under challenging conditions for Clients in the Medical Device, Pharmaceutical and Biotechnology industries. Tobin is both personable and articulate, and I would highly recommend him to any Client requiring expertise in the aforementioned areas.”
Jan L. Dorfman, P.E., President
FPC Denver, Inc.
“Tobin is a pleasure to work with. He is extremely conscientious in doing thorough and quality work, knowledgeable in the subject matter and passionate about the work he does. This results in output of an effective and high-quality product.”
Top qualities: Expert, Good Value, High Integrity
Dalal Murgai, President
Regulatory Outsource Consulting
“Mr. Guarnacci participated in the expansion of a Contract Research Organization’s Quality Assurance Department. His knowledge and application of GCP and GCLP regulation were instrumental in supporting continued growth of the department, facilitating process improvement, and securing critical regulatory compliance of top management.
He remains unwaivering in his passion for quality assurance and its benefit to the industry. I would strongly recommend utilizing his expertise to advance your quality program.”
Jeffrey Kanters, RN, CCRA, RAC (US)
Quality Assurance and Regulatory Compliance Associate
Duke Clinical Research Institute
“I have had the great pleasure of working with Tobin on a 21 CFR Part 806 project involving 4 other team members. Tobin brought key clinical skills and understanding to the team and his involvement was instrumental in allowing us to achieve our goals on time. If we are ever in need of clinical expertise again, Tobin would be my first choice.”
Rob Teeter, Regulatory Affairs Specialist
“Tobin is an expert in the area of Clinical Laboratories and knows CAP/CLIA regulations extensively. Tobin also has a sound working knowledge of cGCPs and has experience auditing vendors and clinical sites for GCP compliance. Post-audit, Tobin writes comprehensive and accurate audit summaries and reports.”
Top qualities: Personable, Expert, Good Value
Nancy Schukraft, Senior Manager – Regulatory Compliance
Ono Pharma USA, Inc. _____________________________________________________________________________________________________________
“Tobin impresses me with his high integrity, solid work ethic and significant depth of knowledge and experience in GCP auditing. Tobin is high energy, enthusiastic and has a great sense of humor. When I need a GCP subject matter expert I call Tobin.”
Maureen Clancy, Senior Recruiter
“Tobin is very passionate about Clinical Quality and Compliance! At Abbott Vascular he was instrumental in developing and driving Clinical Quality where before it was not necessarily at the forefront. Tobin was able to communicate strategy; concise procedural concepts and introduce training up to the highest level of management very effectively. Due to Tobin’s efforts we passed a Regulatory audit with no observations, whereas before, most were doubtful we would pass at all. We came together as a very efficient team! I personally gained better comprehension and awareness that I’ve taken with me to other companies. His knowledge and understanding of regulatory requirements and domestic and international standards are unsurpassed. I highly recommend Tobin!”
Deb Switkowski, Group Leader Clinical Documentation
Abbott Vascular Devices
“Tobin is a very knowledgeable professional in the field of regulatory compliance. He was commissioned to assist my company in retrospective auditing capacity. He ended up being a key facilitator in the work group, which included a wide variety of personalities and skill sets. Even when things were tense, Tobin maintained his professional attitude, sense of humor and enthusiasm for the project. I would request Tobin back for future projects.”
Top qualities: Great Results, Personable, Expert
Leanne Gallison, Senior Clinical Research Manager
“Tobin has the perfect mind-set and skills to be successful as a clinical quality auditor. His attention to detail, his knowledge (from both a clinical and regulatory perspective),sense of humor and his understaning of the “big picture” make him uniquely qualified for any assignment.“
Russell Haber, Senior Clinical Project Manager