This module covers the requirements for specifications that must be in place to ensure compliance with 21 CFR 111 and provides guidance on how to establish them. Specifications for components, ingredients and in-process control points are critical in ensuring that finished product specifications are met. This module also covers the responsibilities of quality control, the requirements for laboratories and provides guidance for conducting a root cause analysis and implementing effective corrective actions. The following subparts of 21 CFR 111 are reviewed:
o Subpart E – Production and Process Control
o Subpart K – Manufacturing Process Control
o Subpart F – Quality Control
o Subpart J – Laboratory Operations
At the end of this module you should be able to:
- Recognize where specifications are required and how to establish them
- Identify how to determine if specification requirements are met
- List the content required for a certificate of analysis (COA)
- Explain how to address out of specification raw materials and finished products
- Recognize how to prevent contamination
- Explain how to determine the root cause of a problem
By completing/passing this course, you will attain the certificate DS Certificate
Terms and Conditions Agreement
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- Links to Other Websites. A Course may contain links to third party websites. Access to any other website linked to the Course is at the user's own risk and NSF is not responsible for the accuracy or reliability of any information, data, opinions, advice or statements found on those websites, and NSF does not exert any editorial or other control over those other sites. NSF provides these links merely as a convenience to You and the inclusion of such links does not imply an endorsement by NSF of any such third party sites or their content.
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- Entire Agreement. This Agreement, its terms and conditions, as well as such other agreements or documents referenced herein, as each may be amended from time to time, constitute the entire agreement between You and NSF with respect to the subject matter of this Agreement and Your use of the Course, and they supersede all previous communications, representations or agreements, whether oral, written or electronic, between the parties with respect to said subject matter. A printed version of this Agreement and of any notice given in electronic form shall be admissible in judicial or administrative proceedings based upon or relating to the terms and conditions of this Agreement to the same extent and subject to the same conditions as other business documents and records originally generated and maintained in printed form.
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