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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
Project Management
I have managed project teams that included engineering and design, construction, equipment procurements, installation, commissioning, and validation.
In a recent project, I was responsible for the start-up of a new Aseptic processing division encompassing a three building campus. Processes were being transferred from Europe, Australia, Japan and US facilities to a newly designed facility that I was accountable for in the US. In this role, I was responsible for all aspects of design, construction, validation and quality as well as interfacing with regulatory agencies.
By the end of the project, I successfully achieved licensure for the products in the EU.
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
“Bob is a detail professional who combines expert knowledge in his field with the ability to help an organization solve difficult problems with creative and practical solutions. Bob is a great communicator to all levels of the organization and adopts a company's culture to ensure he is able to help move associates along a path to success.” March 29, 2009
-Tom Leonardi
Hired Robert as a Engineering, Regulatory, Pharma in 2001
Top qualities: Great Results, Expert , High Integrity
