-
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 Training Services
Clean Room Design
Contamination Control, and Environmental Monitoring for Controlled Environments
Description:
This course explains the regulatory requirements for designing a clean room, from both a US and EU perspective. Participants review facility layouts and understand common design issues that need to be incorporated to facilitate proper flows in their facility. Design of HVAC systems, including pressurization schemes and air flows, is included.
Most likely to benefit:
This course is intended for all personnel involved with the following areas of pharmaceutical and medical device sterile facilities:
• Design
• Construction
• Validation
• Operations
• Monitoring
• Quality
This course will be of interest to Operational staff, Regulatory Affairs, QA/QC and Maintenance.
Duration:
3 hours or 6 hours
Training Services
- Pharmaceutical Utility Systems
- Clean Room Design
- The Contamination Control Plan
- Preparing for Systems-based Inspection
- Implementing a Change Control System
- Assuring Confidence in Laboratory Data
- Hardware and Software Validation
- 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
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
