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 |
| Group PH300 - Consists of PH30, PH32, PH34, PH35 and PH36 |
| $465.00 |
Qty. |
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PH30 - CORRECTIVE AND PREVENTIVE ACTION
To describe
the systematic approach for establishing a corrective and
preventive action (CAPA) system to capture non conformances,
their related quality investigations and trends to
prevent recurrence. This procedure discusses the communication
and documentation activities associated with
the CAPA system. |
| $189.00 |
Qty. |
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PH32 - PRODUCT RECALLS
To describe the requirements and process
for determining whether a product recall, field correction or removal
is reportable to FDA and to define the
reporting requirements for such actions. |
| $189.00 |
Qty. |
|
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PH34 - COMPLAINT HANDLING
To describe the process for
receiving, reviewing and evaluating complaints, and
describe the responsibilities associated with the complaint
handling process. This procedure also describes some
elements of the customer communication and feedback
process. |
| $189.00 |
Qty. |
|
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PH35 - QUALITY INVESTIGATIONS
To describe the procedures for
conducting and documenting investigations of
non conformances which are a failure to meet predetermined material,
product, process, facilities, equipment or system requirements,
or observations or trends that could potentially
affect product quality. |
| $189.00 |
Qty. |
|
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|
PH36 - ANNUAL PRODUCT REVIEWS
To describe the procedures
for performing an annual product review (APR) of all product
lots and related documentation. |
| $189.00 |
Qty. |
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