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. ▇▇▇▇▇▇▇▇▇-▇▇▇▇▇ 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 ▇▇▇▇▇▇▇▇▇-▇▇▇▇▇ 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. 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. ▇▇▇▇▇▇▇▇▇-▇▇▇▇▇ 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 ▇▇▇▇▇▇▇▇▇-▇▇▇▇▇ 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. Maintain limited and controlled access to the Facility. X
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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. 13.2. Amgen will notify Insulet of any requested changes to the Specifications or Manufacturing of the Customized Insulet Device including without limitation changes required by Applicable Law or Government Authority and changes to the following: • Item #1 - Design Requirement Document; • Item #2 - Subsystem components (e.g., hardware, electrical, mechanical and software); • Item #3 - Manufacturing improvement (e.g., procedures, in line testing and equipment); • Item #4 - Lot qualification procedures; • Item #5 - Risk documents; • Item #6 - Shipping process and condition; and • Item #7 - Materials (e.g., packaging component and label artwork). * Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [*]. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. Within [*] calendar days for Items [*] and [*] calendar days for Items [*] after each such notification from Amgen, Insulet will submit to Amgen an assessment of cost and schedule for implementation of the changes. Insulet will implement the changes as agreed upon by the Parties, such agreement not to be unreasonably withheld, including those required by Governmental Authorities or Applicable Law. [*]
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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,
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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

  • Proposed Policies and Procedures Regarding New Online Content and Functionality By February 1, 2017, the Division will submit to OCR for its review and approval proposed policies and procedures (“the Plan for New Content”) to ensure that all new, newly-added, or modified online content and functionality will be accessible to people with disabilities as measured by conformance to the Benchmarks for Measuring Accessibility set forth above, except where doing so would impose a fundamental alteration or undue burden. a) When fundamental alteration or undue burden defenses apply, the Plan for New Content will require the Division to provide equally effective alternative access. The Plan for New Content will require the Division, in providing equally effective alternate access, to take any actions that do not result in a fundamental alteration or undue financial and administrative burdens, but nevertheless ensure that, to the maximum extent possible, individuals with disabilities receive the same benefits or services as their nondisabled peers. To provide equally effective alternate access, alternatives are not required to produce the identical result or level of achievement for persons with and without disabilities, but must afford persons with disabilities equal opportunity to obtain the same result, to gain the same benefit, or to reach the same level of achievement, in the most integrated setting appropriate to the person’s needs. b) The Plan for New Content must include sufficient quality assurance procedures, backed by adequate personnel and financial resources, for full implementation. This provision also applies to the Division online content and functionality developed by, maintained by, or offered through a third-party vendor or by using open sources. c) Within thirty (30) days of receiving OCR’s approval of the Plan for New Content, the Division will officially adopt and fully implement the amended policies and procedures.

  • Ordering Guidelines and Processes 1.13.1 For information regarding Ordering Guidelines and Processes for various Network Elements, Combinations and Other Services, AFN should refer to the “Guides” section of the BellSouth Interconnection Web site, which is incorporated herein by reference, as amended from time to time. The Web site address is: http//▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇▇▇▇▇▇▇.▇▇▇/. 1.13.2 Additional information may also be found in the individual CLEC Information Packages, which are incorporated herein by reference, as amended from time to time, located at the “CLEC UNE Products” Web site address: ▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇▇▇▇▇▇▇.▇▇▇/guides/html/unes.html. 1.13.3 The provisioning of Network Elements, Combinations and Other Services to AFN’s Collocation Space will require cross-connections within the central office to connect the Network Element, Combinations or Other Services to the demarcation point associated with AFN’s Collocation Space. These cross- connects are separate components that are not considered a part of the Network Element, Combinations or Other Services and, thus, have a separate charge pursuant to this Agreement.

  • Filing and Processing A. Filing

  • Jurisdiction and Process In any action between or among any of the parties, whether arising out of this Agreement or otherwise, (a) each of the parties irrevocably consents to the exclusive jurisdiction and venue of the federal and state courts located in the Commonwealth of Pennsylvania, (b) if any such action is commenced in a state court, then, subject to applicable law, no party shall object to the removal of such action to any federal court located in the Commonwealth of Pennsylvania, (c) each of the parties irrevocably waives the right to trial by jury, and (d) each of the parties irrevocably consents to service of process by first class certified mail, return receipt requested, postage prepaid, to the address at which such party is to receive notice in accordance with Section 12.5, and the prevailing parties shall be entitled to recover their reasonable attorneys' fees and court costs from the other parties.

  • CONTRACTOR NAME CHANGE An amendment is required to change the Contractor's name as listed on this Agreement. Upon receipt of legal documentation of the name change the State will process the amendment. Payment of invoices presented with a new name cannot be paid prior to approval of said amendment.