Production and Process Controls Sample Clauses

Production and Process Controls. Flextronics shall develop, conduct, control and monitor product processes to ensure that the Product(s) conform to the Specifications and were produced in substantial compliance with the QSR and ISO 13485.
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Production and Process Controls. Supplying Party shall develop, conduct, control, validate (where process results cannot be fully verified by inspection and testing) in accordance with 21 CFR 820.75 (Process Validation) and 820.70 (g) (Equipment Qualification) and conduct a documented risk analysis for the complete process of manufacturing (such as Process Failure Modes and Effects Analysis (“pFMEA”) or Control Plans, and monitor production processes to ensure that the Product conforms to Product Specifications.
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Production and Process Controls. Supplier shall develop, conduct, control and monitor production processes to ensure that the Product conforms to Specifications. Supplier shall assure that production equipment and quality measurement equipment, including mechanical, electronic, automated, chemical or other equipment, are: (i) suitable for the intended use; (ii) capable of producing valid results; (iii) operated by trained personnel; and, (iv) properly calibrated to the appropriate and suitable standard. If the output of a Supplier’s process is not fully verified by subsequent inspection or test, the Supplier shall validate the process. The Supplier shall create a validation protocol (describing the planned activities) and a validation report (documenting the outcome of the planned activities). A change or a deviation from a validated process shall be reviewed and if appropriate revalidated. Supplier shall keep records of the validation and revalidated activities and make them available to CCI upon request. If requested by CCI, Supplier shall create and maintain a process map, process failure modes and effects analysis (pFMEA), and process control plans for all steps from receiving through shipping.
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Production and Process Controls. 13.1. Insulet will maintain written procedures for production and process control of the Customized Insulet Device. Insulet will sterilize the Customized Insulet Device in accordance with the Insulet Product Definition Document INSPR020-PDD, Amgen Delivery Device ADD specifications. Sterilization results will be provided on the Certificate of Conformance.
Sample 1
Production and Process Controls. Xxxxxxxxx-Xxxxx shall generate the master batch production record, labeling and packaging procedures for the Manufacture of the Product based on the information supplied by Auxilium. The master batch production record(s) and subsequent revisions shall be subject to the approval of Xxxxxxxxx-Xxxxx and Auxilium, and will contain a summary of any change(s) with appropriate justification(s) for change(s). Each batch shall be Manufactured in accordance with a batch production record, which is a uniquely identified copy of the master batch production record.
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Production and Process Controls. Xxxxxxxxx-Xxxxx shall generate the master batch production record, labeling and packaging procedures for the Manufacture of the Product based on the information supplied by Dyax. Both Dyax and Xxxxxxxxx-Xxxxx must approve the master batch production record. Each batch shall be Manufactured in accordance with a batch production record, which is a uniquely identified copy of the master batch production record.
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Production and Process Controls. 11.1 Maintain limited and controlled access to the Facility. X
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Production and Process Controls. Supplier shall establish procedures to develop, conduct, monitor, control, validate processes (where process results cannot be fully verified by subsequent inspection and testing) and qualify equipment. Validation activities, process changes and deviations shall be documented. Supplier shall establish and maintain procedures for monitoring and control of production processes to ensure that the Product conforms to Product Requirements, i.e. ISO 13485 7.1 (Planning of Product Realization). The monitoring and control methods, data, date performed, individual(s) performing the process and the major equipment used shall be documented.
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Related to Production and Process Controls

  • Access Controls a. Authorized Access - DST shall have controls that are designed to maintain the logical separation such that access to systems hosting Fund Data and/or being used to provide services to Fund will uniquely identify each individual requiring access, grant access only to authorized personnel based on the principle of least privileges, and prevent unauthorized access to Fund Data.

  • Production of Witnesses; Records; Cooperation (a) After the Effective Time, except in the case of a Dispute between Parent and SpinCo, or any members of their respective Groups, each Party shall use its commercially reasonable efforts to make available to the other Party, upon written request, the former, current and future directors, officers, employees, other personnel and agents of the members of its respective Group as witnesses and any books, records or other documents within its control or which it otherwise has the ability to make available without undue burden, to the extent that any such person (giving consideration to business demands of such directors, officers, employees, other personnel and agents) or books, records or other documents may reasonably be required in connection with any Action in which the requesting Party (or member of its Group) may from time to time be involved, regardless of whether such Action is a matter with respect to which indemnification may be sought hereunder. The requesting Party shall bear all costs and expenses in connection therewith.

  • Policies and Procedures i) The policies and procedures of the designated employer apply to the employee while working at both sites.

  • Accounting Policies and Procedures Permit any change in the accounting policies and procedures of the Company or any Guarantor, including a change in fiscal year, provided, however, that any policy or procedure required to be changed by the Financial Accounting Standards Board (or other board or committee thereof) in order to comply with Generally Accepted Accounting Principles may be so changed.

  • Review and Procedure Limitations The Asset Representations Reviewer will have no obligation (i) to determine whether a Delinquency Trigger has occurred, (ii) to determine whether the required percentage of Noteholders has voted to direct a Review, (iii) to determine which Receivables are subject to a Review, (iv) to obtain or confirm the validity of the Review Materials, (v) to obtain missing or insufficient Review Materials (except to the extent set forth in Section 3.04), or (vi) to take any action or cause any other party to take any action under any of the Basic Documents to enforce any remedies for breaches of any Eligible Representations. The Asset Representations Reviewer will only be required to perform the Tests provided in Exhibit A and will have no obligation to perform additional testing procedures on any ARR Receivables or to consider any additional information provided by any party. The Asset Representations Reviewer will have no obligation to provide reporting or information in addition to that described in Section 3.07. However, the Asset Representations Reviewer may review and report on additional information that it determines in good faith to be material to its performance under this ARR Agreement and may re-perform a Review with respect to an ARR Receivable as contemplated by Section 3.09. The Issuing Entity expressly agrees that the Asset Representations Reviewer is not advising the Issuing Entity or any Noteholder or any investor or future investor concerning the suitability of the Notes or any investment strategy. The Issuing Entity expressly acknowledges and agrees that the Asset Representations Reviewer is not an expert in accounting, tax, regulatory, or legal matters, and that the Asset Representations Reviewer is not providing legal advice as to any matter.

  • Xxxxxxxx-Xxxxx; Disclosure Controls The Company is in compliance in all material respects with all of the provisions of the Xxxxxxxx-Xxxxx Act of 2002 which are applicable to it. The Company maintains disclosure controls and procedures (as such term is defined in Rule 13a-15(e) and 15d-15(e) under the Exchange Act), and such disclosure controls and procedures are effective.

  • Quality Agreement Concurrently with execution of this Agreement, the Parties will enter into an agreement that details the quality assurance obligations of each Party with respect to the Manufacture and supply of Supplied Products under this Agreement (the “Quality Agreement”). Each Party shall perform its obligations under the Quality Agreement in accordance with the terms and conditions thereof. In the event of a conflict between the terms of the Quality Agreement and the terms of this Agreement, the provisions of the Quality Agreement shall govern.

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