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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
Assuring Confidence in Laboratory Data - Part 11 Compliance
Description:
This course provides an overview of the qualification requirements to ensure that laboratory data is reported and stored in a manner compliant with Part 11 requirements (as well as EU Annex 11). Elements of IQ and OQ are covered, as well as Excel tools required to view data.
Most likely to benefit:
This course is intended for persons who are directly involved with the manufacturing and testing of drugs and medical devices. It is recommended for:
• Production Managers
• QC/QA Managers
• Environmental Monitoring Personnel
• QC/QA Lab Personnel
• Process Design/Engineering Personnel
• Maintenance Managers
Duration:
1.5 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
-David Porter, Senior Director, Training, Vectech Pharmaceutical Consultants, Inc. worked indirectly for Robert at The Ferer Group
