Jim Agalloco

“Jim was a consultant in a FDA project. I learned a lot from him; his experience in FDA inspections, aseptic tecniques and sterile manufacturing is huge!”

“Jim is one of the few Uberexperts in pharmaceutical sciences and in particular in sterile manufacturing. His area of expertise covers all activities from facility design, through entire manufacturing cycles ending up with controls and regulatory expertise. He is so great because he knows so much and therefore can manage the great areas instead of just saying "no, in cannot be done". He published many specialized books in this field however in an understandable way, again proving, the complicated matter can to be explain in a simple way. In summary, I am highly recommending as the great scientist having a great deal of common sense and as a great person. Michael W. Major”

“Jim is the total package. Jim has always been the source of reasonable regulatory and compliance along with solving the current problems of the industry”

“I have known Mr. Agalloco, while I was working with a book. I had requested Mr. Jim Agallaco for a chapter, he has provided me without any hesitation. Mr. Agalloco, is always my mentor whose ideas are always based on reliance on sound science rather than inclination to regulatory obfuscation. He is a living legend and most respected expert due to his commanding presence in the field of Aseptic process validations. When ever I need a solution that I couldn't find in his books, I always post a mail. Mr. Agalloco used to give a solution immediately, though he was ever busy person. I know that Iam not eligible to recommend such a great person, but Iam taking my chance to have this honor of recommending him.”

“I have always enjoyed hearing Jim speak at conferences and seminars, and have had the opportunity to use his consulting services with great results. Very knowledgeable with hands-on experience. And, a fun person to travel with.”

“Jim has been a consultant to some of our clients and I have worked with him directly/indirectly on several projects since 2006. I have found Jim very knowledgable, pragmatic, creative, forthright and a responsive expert who has demonstarted skills in problem-solving and resolving regulaory matters & documentation for new, generic or marketed drug products especially parenterals.”

“Whenever peers in the industry discuss successfully executed Validation projects, it is not uncommon to hear the name Jim Agalloco. Before becoming President of the PDA and a consultant, Jim had already established himself as an industry leader in validation. While serving as Director at BMS, Jim built a Validation Team that was second to none in the industry. His pragmatic approach in combining scientific soundness and common sense are strengths that have served everyone who has had the pleasure of working with him.”

“I have used Jim as a resource numerous times. His involvement with GE Healthcare has been during Isolator Technology design, technology transfer and creation a sterility assurance package . Jim is always outspoken, always informative, and always highly recomended.”

“Jim came in very early on our project to build an aseptic pilot plant, and was instrumental in convincing our senior management on taking the plunge into isolation technology. He brought together a lot of great experience and knowledge and gave us what became a very sound and adaptable facility concept and specifications. The results were excellent.”

“Jim impressed me with his attention to detail, his thorough knowledge of the issues, his objectivity, his friendliness, and his willingness to discuss the science underlying the projects on which we worked together. As a Project Leader and Group Leader in the QC Development Labs, I respected Jim and was pleased to count him as a colleague.”

“One of the legends in the business whose contributions and technical skills have established key practices and principles. Jim remains a leader and his work and writing/teaching continue to challenge and educate arising from his extremely solid science and risk - based expertise.”

“Having worked with Jim over the past 25 years, he is the subject matter expert I go to related to isolators in particular and in finding creative ways to improve quality/compliance while containing costs in general. He has an eclectic knowledge and knows how to balance GMP Compliance with the P&L and Balance Sheet without ever compromising his own professional standards of excellence.”

“I have worked with Jim on several occasions. He is extremely knowledgeable of microbiology issues pertaining to aseptic processing and sterilization of pharmaceuticals. He is the best I have worked with in terms of applying his knowledge to rapidly create scientifically sound and practical plans for process design, remediation, or validation activities.”

“I worked for Jim when he was the Dir. of Worldwide Validation at BMS. Jim was a pioneer in the field of Validation and at the time he helped establish many of the standards still in use today. It was a great honor to have worked for Jim who treated all of his employees as part of a team. He facilitated a powerful collaborative approach to resolving the numerous challenges that existed.”

“A science & engineering based, fact-driven approach is the foundation for Jim’s sound advice as we pursue novel processing approaches. Jim has provided in-house training and consulting on sterilization and processing approaches for our projects. Dedication to the pharma industry and serving our ultimate client, the patient, are Jim’s prime motivators.”

“Jim is a true leader in the industry. His views are always scientifically sound and devoid of the baseless dogma that surrounds compliance-based consulting. I have worked as both a colleague and a client and would put my trust in Jim without reservation.”

“Jim is a well known in the pharmaceutical manufacturing industry. He is recognized as an expert in advanced aseptic processing. He has shown excellent leadership qualities both as a team leader on projects and as an industry spokesperson. His leaership ability was seen during his tenure as the President of the Parenteral Drug Association. Jim is extremely helpful to his clients”

“When I don't find answers in Jim's book i.e "Validation of Pharmaceutical Processes", I have called on Jim to discuss Validation/Facility issues. His simplistic approach and breadth of knowledge have more than often helped us move ahead. We also brought Jim for on-site training and he was extremly effective in aligning validation-think across various departments.”

“I came to know James Agalloco as the European Director of PDA (2002 to 2005). He is highly respected in Europe in the area of sterile manufacture. He is one of the few opinion leaders in this area worldwide.”