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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 and Quality Master Project Plans
The primary way to ensure success on any project is to develop a strong plan with a detailed road map to enable the project team to meet defined goals and objectives. Without a strong plan, there is too much discussion and debate during the critical execution phases surrounding the qualification and/or regulatory requirements (especially when a facility will supply material to various countries). I have developed strong, well defined, Validation and Quality Master Project Plans to identify the required criteria against which to measure the qualification activities. This avoids arduous meetings when dozens of qualification activities are occurring simultaneously.
For one particular project after developing the master planning documents, I lead the team to qualify the facility and selected pieces of equipment.
The final result was the facility was brought on-line to manufacture their product after the successful review and licensure by the regulatory authorities.
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
