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Home - About Bob Ferer
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- 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
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The Ferer Group Training Services
Validation
Description:
This course provides an overview of the regulatory requirements for the qualification activities for manufacturing equipment and processes. Participants design a risk assessment process to establish the appropriate acceptance criteria as well as to develop the framework of a qualification protocol. Lessons learned from previous qualification activities are discussed through examples supplied by the participants and case studies. These are designed to help participants avoid costly pitfalls.
- Computer Networks and Automation Systems
- Critical Utilities
- Sterilization
- Depyrogenation
- CIP / SIP
- Compressed Gas systems (Cryogenic liquid, compressors, dryers)
- Fillers
- Cappers
- Vial and stopper washers
- Compounding / Manufacturing
- HVAC and BAS
- Inspection
- Labeling
- Packaging
Most likely to benefit:
This course is intended for persons who are directly involved with the manufacturing of sterile drugs and medical devices, as well as other products that are required to be free of certain objectionable organisms. It is recommended for:
- Production Managers
- QC/QA Managers
- Process Design/Engineering Personnel
- Qualification / Validation Personnel
Duration:
1.5 hours per subject
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
