RALPH W. DONNELLY
President

R. Donnelly and Associates Inc. provides consulting services to FDA regulated food and medical products industries. Mr. Donnelly has provided the guidance and management expertise to develop RDA from concept to reality. He has provided the quality and technical leadership for the success of RDA since 1990 and is a frequent course leader and speaker for industry organizations.

Typical Projects

Mr. Donnelly has managed the expansion initial plant design and construction of Cook Pharmaceutical Solutions (currently Baxter Pharmaceutical Solutions) and the recently completed expansion (1998-2001) of the facility using both modular and conventional construction methods. This project was the first of its type in the United States. It saved the client a minimum of six months in construction, start-up and validation time. Mr. Donnelly supervised and consulted on the design, construction, start-up and validation of the first Cook Imaging Corp. parenteral facility. Mr. Donnelly has also managed the upgrades, validation and plant approval of a veterinary products facility that was under a FDA Regulatory Letter. In addition, he has consulted and provided advice on corrective action for a device manufacturer after the company had received a Regulatory Warning Letter, and participated in various cGMP inspections of pharmaceutical and medical device manufacturing facilities.

Current Professional Activities

Member of Sterling Who’s Who Executive Edition
Member of the Parenteral Drug Association
Charter Member International Society of Pharmaceutical Engineering (ISPE)
Currently serving on the Editorial Committee (ISPE)
ISPE Course Leader and Speaker
Sterilization Seminar
Biotechnology Facility Design Seminar
Biotechnology Facility Design and Maintenance Career Development Workshop
Plant Engineering Seminar
HVAC Design I and II Outsourcing in the Pharmaceutical Industry
IAT Course Leader: HVAC System Design in the Pharmaceutical Industry, London, England
Institute for Validation Technology
HVAC – “Designing Dynamic Air Pressure Controls That Work” (Brussels Belgium and San Francisco)
PROJECT MANAGEMENT –“Sterile Facility Design to Validation in 18 Months”

Articles Published

Pharmaceutical Engineering - May/June 1989 “The Design and Construction of One of the First Large Scale Biopharmaceutical Mammalian Cell Culture Facilities"
The Validator - November 1994 “Validation in the Medical Products Industry”
ISPEAK Magazine - March 2003 “Developing Quality Systems for the Pharmaceutical Industry”
ISPEAK Magazine - May 2003 “Quality Systems Manual an Organizational Structure”

Education

Bachelor of Science Mechanical Engineering, Industrial Engineering Minor - LeTourneau University