The Ferer Group Training Services
Keeping Equipment in a Validated State: Recertification and Rational Revalidation
Description:
This course discusses the various quality elements and systems required to ensure that equipment and utilities remain in a qualified or validated state. While touching on each individual system (e.g., change control, PM, calibration, etc.), it also covers how these systems must work together to minimize the duplication of paperwork.
Most likely to benefit
This course is intended for managers, supervisors, engineers, chemists, scientists, technicians, and formulators. This course is also valuable to documentation specialists, auditors, and those in regulatory affairs. Personnel from the following departments will find the course beneficial:
- Research and Development
- Quality Assurance and Control
- Manufacturing/Operations
- Facilities
- Audit
- Training
- Technical Support
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 am relatively new to being a consultant. What I learned from Bob about how to be an excellent consultant was priceless. This learning came less from what he actually told me (although this in itself was invaluable), but much for from watching him in his role as a consultant. He was absolutely dedicated to the client, but would never compromise his quality approach just to satisfy the client. This meant that at times he would need to confront the client, but this was always done in a highly professional and productive manner. At the end of the day, everyone was the better for it, especially the client. I would not hesitate to work with or for Bob in the future.” January 16, 2009
-David Porter, Senior Director, Training, Vectech Pharmaceutical Consultants, Inc. worked indirectly for Robert at The Ferer Group