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- 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
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- Keeping Equipment in a Validated State
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The Ferer Group Training Services
Understanding and Preparing for Systems-based Inspection
Description:
There are 6 parts to a systems-based inspection: Quality System, Facilities and Equipment System, Materials System, Production System, Packaging and Labeling System, and Laboratory System. This course explains how the FDA conducts systems-based inspections and reviews examples of FDA 483 observations to prepare your facility for your PAI. Group discussions of actual FDA findings are designed to highlight common compliance gaps.
Most likely to benefit:
This course is intended for persons who are directly involved with the manufacturing or testing of sterile drugs and medical devices. It is recommended for:
• Production Managers
• QC/QA Managers
• Environmental Monitoring Personnel
• QC/QA Lab Personnel
Duration:
1.5 hours or 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 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
