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- 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
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The Ferer Group Training Services
Design of HVAC Systems for Aseptic Facilities
Description:
This course illustrates the regulatory basis for HVAC design in aseptic facilities in both the US FDA Aseptic Processing Guidelines as well as the EU Annex 1. It covers specific design elements of filtration, airflow, and pressurization as well as equipment specialized to provide localized clean zones within the processing area.
Most likely to benefit:
This course is intended for all personnel involved with the following areas of pharmaceutical and medical device facilities:
- Design
- Construction
- Validation
- Operations
- QA/Q
Duration:
3 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
“Bob is a very knowledgeable consultant in most aspects of engineering and Quality Assurance in the pharmaceutical and biotech arenas. He offers pragmatic but compliant solutions to problems and is acutely aware of cost management and added-value concepts. Bob can communicate lucidly at all levels within an organisation and offers great mentoring and tutoring skills in all he touches.” April 9, 2009
-John Brooks
Hired Robert as a QA Consultant in 2007
Top qualities: Great Results, Personable , High Integrity
