James J. Farley
Cardinal Consulting and Training
F D A Regulatory
101 Captain John's Drive
Savannah, GA 31410
Phone:
(912) 898-8505
Fax:
(912) 898-1270
E-mail: Jim Farley
Web Page: Cardinal Consulting and Training
Specialties:
- Pharmaceutical
- Analytical
- Food & Drug Administration, Regulatory
- Management Training
- Subject Matter Expert for Attorneys
Services:
Cardinal Consulting and Training provides individuals or teams of experts to help you deliver new products to the marketplace by assisting in Regulatory, Technical, and Management areas such as the following, thereby avoiding regulatory and other delays.
- Food and Drug Administration Compliance
- Quality Audits and Implementation of Changes
- Establish/Review Quality Assurance Procedures and compliance with GMPs, including GLPs
- Prepare the Chemistry, Manufacturing, and Controls section of a New Drug Application (CMC section of NDA)
- Prepare Drug Master Files (DMFs)
- Prepare for Pre-Approval Inspections (PAIs)
- Process Validation
- Establish program for Corrective Action; Preventive Action (CAPA) including Root Cause Analysis (RCA)
- Establish system for Out of Specification (OOS) results and for Deviations
- Consult/assist in responses to FDA Warning Letters
- Consult/assist in responses to FDA "483"s
- Technical
- Laboratory Procedures - Development and Validation
- Package/Product Compatibility
- Selection and Testing of Rubber Stoppers and Plastic and Glass Components
- Management
- Laboratory Management
- Work Flow Design
- Strategic Planning
- Establish responsibilities and performance criteria for contractor organizations
- Establish goals, responsibilities, and performance criteria for departments to eliminate errors and unnecessary redundancies and to ensure maximum efficiency
- Training - Design and present training programs in the following:
- CAPA
- GMPs
- Leadership skills for new managers
- Project planning and management to include:
- Acquisitions
- Affiliations
- New facility establishment (site selection to first product shipped or first test conducted)
- Direct a department and effectively interact with other departments
- Preparation for an FDA inspection - GMP or Pre-Approval
- Public Speaking skills for your personnel. All other things being equal, the person who speaks better in public is the more believable.
How We Work:
Our philosophy and our methods are different from those of many larger consulting firms.
The difference - we do not imply that you need a large group of consultants who will remain at your locations for extended periods of time. That may be necessary at certain times, such as when recovering from a consent decree. However, many compliance problems are not of that magnitude and can be corrected more readily.
Instead, we send one consultant - sometimes two, depending on the nature of the situation - for a predetermined short period of time, anywhere from days to a week or more, to identify the problem specifically and propose a solution to it.
When we all agree on the nature of the problem and the proposed solution we will present a realistic time frame to completion. Then, upon your approval, we "fix the situation" and bring you into compliance.
This manner of identification and solution has been proven to be the most cost effective for you, our client.
Bio:
James J. Farley has 35 years experience in the Pharmaceutical and Pharmaceutical Packaging industries with extensive experience in the areas of Laboratory Management and Food and Drug Administration Regulations.
Before starting Cardinal Consulting and Training, he spent 8 years with the FDA. As Director of the Science Branch of the Philadelphia District, whose Laboratory was involved in evaluating the procedures of the Pharmaceutical firms in the states of Pennsylvania, Delaware and New Jersey, he sent chemists on domestic and international inspections. Before that, he was employed as a Research Chemist at major Philadelphia area pharmaceutical firms.
Jim holds a B.A. in Chemistry from LaSalle College, an M.S. in Physical Chemistry from St. Joseph's College, and an MBA in Marketing and Finance from Temple University. He has taught in the MBA program of Penn State University and in the Temple University School of Pharmacy's Master of Science in Quality Assurance Regulatory Affairs program where he instructed professionals at the graduate level.
Jim likes to explore and instruct "the business end of science" as detailed in his books, Effective Financial Tools for Scientific Managers and most recently The Executive MBA for Engineers and Scientists, both published by CRC press.
This combination of Industry, FDA, and Academic experience has served the needs of many clients in the United States and Internationally.
