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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
Validation Consultation
I have experience with the full spectrum of validation activities from validation master planning through performing the hands-on qualification. My managerial experience in this area includes the on-site management of employees during validation projects, particularly for facility, critical utility, production equipment, and process validation. I typically employ Microsoft Project to budget cost and schedule/coordinate activities.
My experience ranges from developing validation strategies for critical manufacturing processes to the writing and execution of utilities, equipment, and system validation protocols.
In this capacity there are many examples dealing with both small and large scale complicated efforts. One of the most memorable was a project where the project was fast-tracked to beat a competitor to market. This involved working around the clock to qualify the equipment, facility, utilities, and environment to meet the client’s schedule.
By the end of the project, all the required qualification activities were successfully completed to the client’s satisfaction
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
-Mark Donohue,
Validation Contractor, PharmTech, Inc. (Vectech)
Was with another company when working with Robert at Vectech Pharmaceutical Consultants
