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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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The Ferer Group Training Services
Hardware and Software Validation
Description:
This course provides an introduction into Risk Based methods for the qualification of hardware and software systems in compliance with FDA 211 Part 11 as well as EU Annex 11. Participants collectively prepare risk assessments for sample systems and determine the appropriate qualification activities as well as the appropriate criteria for a successful and useful qualification study to demonstrate acceptability.
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:
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
“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
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