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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
Engineering Design and Design Review
I’ve designed and sized critical utility systems, including USP Purified Water, Clean Steam, Compressed Gases, and Water for Injection systems. In addition, I participated in team efforts to design and lay-out both new and renovated pharmaceutical manufacturing facilities.
I have ‘started up’ and commissioned systems in which I was also involved in the design, as well as, managing the engineering review and construction quality control of new facilities to assure that the design complied with the cGMPs and the user’s requirements.
For one specific project, I led a team of engineers to perform a design review on an environmentally classified manufacturing facility. We were performing our review prior to developing qualification protocols. We discovered a significant issue in the design of the HVAC that required redesign. Had we not discovered this issue, the client would have experienced a significant delay and reconstruction cost associated with the remediation.
The end result was a facility that was inspected and licensed to manufacture their product with minimal observations.
Consulting Services
- Project Management
- Operations Management
- Engineering Design and 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
