-
Home - About Bob Ferer
- Consulting Services
- Training Services
- Pharmaceutical Utility Systems
- Clean Room Design
- The Contamination Control Plan
- Preparing for Systems-based Inspection
- Implementing an Effective Change Control System
- Assuring Confidence in Laboratory Data
- Hardware and Software Validation
- Design of HVAC Systems for Aseptic Facilities
- Using Spreadsheets in the Laboratory
- Sterile Filtration and Integrity Testing
- Managing Startup Project Teams
- Validation
- Keeping Equipment in a Validated State
- Regulatory Resources
- Contact
The Ferer Group Consulting Services
Operations Management
Prior to entering the consulting field, I was the Sterile Facility Manager for a generic parenteral manufacturer. I use this experience to assist clients needing facility management support. I’m a ‘hands on’ manager, and as such, I prefer to work in the field throughout the operation, including component preparation and sterilizing, formulation, filling, inspection, labeling and packaging.
My managerial experience includes a project where the successful completion of Phase III clinical trial material was driven by my leadership capabilities. In this particular project, I assumed responsibility for production start-up and day-to-day operations. I led the development of all the required manufacturing and operations procedures, performed the required training and qualification activities, maintained the facility under a state of environmental control, and worked hand in hand with the engineers and operators.
At the end of this project, we successfully manufactured and delivered the clinical trial material on time.
Consulting Services
- Project Management
- Operations Management
- Design Review
- Validation Consultation
- Validation & Quality Master Project Plans
- Quality Assurance & cGMP Compliance
- Mock / Pre-Approval Inspection Audits
- Supplier / Vendor Audits
- SOP / SWI Preparation
- Expert Witness
Testimonial
“I worked with Bob Ferer on several projects over a period of several years. He was always very adept at getting to the heart of the matter and addressing the needs of the client that were truly consequential. This approach kept costs low and results high. Bob was always and remains well spoken, precise and pragmatic. I will always consider him one of the most intelligent and knowledgable professionals I have worked with, and one of the best friends I have come to know.” March 27, 2009
-David Porter, Senior Director, Training, Vectech Pharmaceutical Consultants, Inc. worked indirectly for Robert at The Ferer Group
