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Change Control Combo
List Price: $298.00
Price: $178.95
You Save: $119.05 (40 %)
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Item Number: CCCombo
Special Edition - Change Control Implementation
Topics in these nine information-packed articles include:
- Validation and Change Control
- The Training Side of Change Control
- Considerations in Effectively Managing Change Control Issues
- Characterizing Design Changes Throughout the Product Lifecycle
- The Management of Change Control or Some Facsimile Thereof
- Change Control FD-483 Citations ? What Went Wrong?
- Change Control: Seven Pharmaceutical Manufacturers Share Their Experiences
- Implementing a Medical Device Change Control Program for Computer Validation Documentation
- Designing the Perfect Change Control System
A Practical Guide to Change Control System Management
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This 42 page Technical Guide provides a step-by-step approach to implementing effective change control procedures. This exclusive Technical Guide reviews such topics as:
- cGMP Regulations and change control
- Change control management
Possible changes encountered in Pharmaceutical Manufacturing including:
- Product development phase
- Facility changes
- Utilities changes
- Equipment changes
- Component changes
Process Changes
Change Control management tools including how to address:
- Deviations
- Nonconforming materials control
- Hold for release issues
- Out-of-specifications investigations
- Validation Change Control issues
- Quality failure/incident investigation
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Product Reviews
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PJA
(Unknown)
5/16/2008 6:05 AM
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