Corrective and Preventive Action. A corrective and preventive action system will be managed and maintained by Seller as necessary to meet the requirements of the QSR and ISO 13485 or otherwise as a Seller of Products to Buyer in accordance with Section 5.1.
Corrective and Preventive Action. Actions taken in response to an incident or Deviation with intent to correct or eliminate the root cause for the occurrence and to prevent reoccurrence.
Corrective and Preventive Action. Supplier shall submit a corrective and preventive actions are submitted to Xxxxx quality team within 14 working days after receipt of complaint. Supplier can use 8D process approach to solve the problem or any other method approved by Xxxxx. Supplier shall take approval from Xxxxx quality team on the submitted corrective action report with the proof. Supplier shall provide traceability of improved lot once the corrective actions are implemented. If required supplier shall allow Xxxxx quality team to verify the implemented corrective actions. Xxxxx shall assist supplier in training on 8D process or any other as part of vendor development. For these supplier can contact Xxxxx sourcing team.
Corrective and Preventive Action. 5.13.1 KMC Systems Documents 5.13.1.1 781-03021: Request for Corrective and Preventive Action 5.13.1.2 781-03022: Customer Complaint Process 5.
Corrective and Preventive Action. If in our verifying and inspecting we do find something wrong with the product, we record the problem, and take appropriate action to correct it. We identify the root cause of the problem and take action to prevent it from happening again.
Corrective and Preventive Action. SDIX shall have written procedures in place to document and investigate all related quality issues to include identification of root cause with corresponding corrective/preventive action.
Corrective and Preventive Action. 17.1. Insulet will establish and maintain a corrective and preventive action (CAPA) program in accordance and compliance with applicable requirements of Regulatory Authorities.
17.2. Trending and analysis of all non-conformances will be performed by Insulet to verify the effectiveness of corrective and/or preventive actions and such trending and analyses will be reviewed with Amgen during the quarterly Quality and Compliance Review.
17.3. After each Non-Conforming Lot and after completing the obligations set forth in Section 16.1 and 16.2 of the Quality Agreement, Insulet and Amgen (through its [*]) shall mutually agree on corrective action to resolve the cause of Non-Conformance, prior to conducting another production run.
Corrective and Preventive Action. Should any audit pursuant to Article 8.1 by CG reveal any deficiencies concerning the performance by the audited Party, the Parties shall without undue delay discuss and agree upon in good faith how to redress such deficiencies and appropriate corrective and preventive action to be taken, and the relevant Party shall undertake commercially reasonable efforts to redress such deficiencies and implement such corrective action. In case audit right is granted to CA, same provisions will apply vice versa.
Corrective and Preventive Action. CAPA System: A corrective and preventive action as defined in 21 CFR 210 and 211. Certificate of Analysis (COA): A listing of all results for tests conducted on samples of the lot of the Product compared to the specifications and listed in regulatory applications. Certificate of Compliance (COC): A statement that the lot of Product was manufactured, packaged and tested in accordance with cGMPs. Contractee: The facility/organization responsible for defining expectations of the contractor. Contractor: The facility/organization responsible for the manufactured Product and the associated services. Corrective Action: action taken to correct an immediate problem and prevent reoccurence of an undesirable event or deviation. Deviation: Unexpected, unplanned or unforeseeable event, departure from normal processing or operation, or departure from normal or expected values (i.e. out of limits). Investigational New Drug Application (IND): An application submitted to the FDA relative to Investigational New Drug clinical trials. Lot: A Batch, or a specific identified portion of a batch, having uniform composition and quality according to specified requirements.
Corrective and Preventive Action. A corrective and preventive action system will be managed and maintained by Minnetronix as necessary to meet the requirements of the QSR (21 CFR 820) and ISO 13485 or otherwise as a seller of products to Client in accordance with Section 5.1.
