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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
Purchase the Reference Guide to Pharmaceutical Manufacturing Change Control titled “Change Control Combo” for $178.95 online from IndustryMatter.com. This resource guide is comprised of 2 Handbooks and a CD-ROM.
Experts and regulatory representatives who understand change control processes from the laboratory through manufacturing prepared this pharmaceutical manufacturing change control guide. It is an outstanding learning tool that can be used for change control management at pharmaceutical manufacturing plants.
Change control is important for the profitability of pharmaceutical companies and for safeguarding the quality of the drugs produced. Pharmaceutical quality assurance procedures and effectively managing change control issues are two key topics covered in this pharmaceutical production guide. The FDA published an excellent reference guide titled "Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations" which is also worth reading.
The materials in this resource guide were compiled form reference materials supplied by the Institute of Validation Technology.
Through timely conferences, educational publications, and other training products, the Institute of Validation Technology (IVT) continually advances validation technology and practice, as well as helping pharmaceutical companies comply FDA regulations. The IVT is a validation and compliance reference library featuring a database of technical journals, magazines, and articles.
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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PJA
(Unknown)
5/16/2008 6:05 AM
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