The Ferer Group Training Services
Implementing an Effective Change Control System
Description:
This course provides information on how to establish and maintain a compliant change control program. It covers relevant FDA requirements and regulatory requirements for change control. Specific examples of audit strategies and metrics to determine the status of your system are discussed.
Most likely to benefit:
This course will be of utmost interest to:
• Quality Control
• Regulatory Affairs
• Manufacturing
• Quality Assurance
Duration:
3 hours or 6 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