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Group MD400 - PRODUCTION AND PROCESS CONTROLS
Medical Device Group - Consists of MD40, MD41, MD42, MD46, MD47 and MD48 |
| $555.00 |
Qty. |
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MD40 - CALIBRATION AND PREVENTIVE MAINTENANCE
To describe
the procedures for ensuring that inspection, measuring,
test and process equipment are routinely calibrated,
inspected, checked, and maintained to ensure fitness for use. |
| $189.00 |
Qty. |
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MD41 - BUILDING/FACILITY SANITIZATION
To describe the general
procedures for cleaning and sanitizing buildings and facilities
used in the manufacture, processing, packaging or
holding of the product in order to control and prevent product contamination. |
| $189.00 |
Qty. |
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MD42 - PEST CONTROL PROGRAM
To describe the procedures for
use of suitable rodenticides, insecticides, fungicides or fumigating
agents to prevent pest infestations of facilities used in
the manufacture, processing, packaging and holding of the
product. |
| $189.00 |
Qty. |
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MD46 - PROCESS VALIDATION
To describe and document the policies and procedures for validation activities related
to facilities, utilities, processes, equipment, tooling, test
methods, and equipment which directly or indirectly affect
manufacture of the product. (Software
validation is covered in MD48 below.) |
| $189.00 |
Qty. |
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MD47 - FINISHED PRODUCT RELEASE
To describe the procedures
to assure that all finished products are tested and
released for distribution only after verification of conformance
to all applicable manufacturing, quality, and regulatory
requirements. |
| $189.00 |
Qty. |
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MD48 - SOFTWARE VALIDATION
To describe software validation activities to ensure that software complies
with established software requirements and satisfies its intended use. |
| $189.00 |
Qty. |
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