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.
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.
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. [*]
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.
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,
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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Production and Process Controls. Maintain limited and controlled access to the Facility. X

Related to Production and Process Controls

  • Proposed Policies and Procedures Regarding New Online Content and Functionality By October 31, 2017, the School 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 School to provide equally effective alternative access. The Plan for New Content will require the School, 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, alternates 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 School’s 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 School 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, PLI 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//xxx.xxxxxxxxxxxxxxx.xxxxxxxxx.xxx/. 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: xxxx://xxx.xxxxxxxxxxxxxxx.xxxxxxxxx.xxx/guides/html/unes.html. 1.13.3 The provisioning of Network Elements, Combinations and Other Services to PLI’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 PLI’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 (a) Each Credit Party irrevocably submits to the non-exclusive jurisdiction of any New York State or federal court sitting in the Borough of Manhattan, The City of New York, over any suit, action or proceeding arising out of or relating to this Agreement (including the Multiparty Guaranty) or the Notes. To the fullest extent permitted by applicable law, each Credit Party irrevocably waives and agrees not to assert, by way of motion, as a defense or otherwise, any claim that it is not subject to the jurisdiction of any such court, any objection that it may now or hereafter have to the laying of the venue of any such suit, action or proceeding brought in any such court and any claim that any such suit, action or proceeding brought in any such court has been brought in an inconvenient forum. (b) Each Credit Party consents to process being served by or on behalf of any holder of Notes in any suit, action or proceeding of the nature referred to in Section 22.8(a) by mailing a copy thereof by registered or certified mail (or any substantially similar form of mail), postage prepaid, return receipt requested, to it at its address specified in Section 18 or at such other address of which such holder shall then have been notified pursuant to said Section. Each Credit Party agrees that such service upon receipt (i) shall be deemed in every respect effective service of process upon it in any such suit, action or proceeding, and (ii) shall, to the fullest extent permitted by applicable law, be taken and held to be valid personal service upon and personal delivery to it. Notices hereunder shall be conclusively presumed received as evidenced by a delivery receipt furnished by the United States Postal Service or any reputable commercial delivery service. (c) Nothing in this Section 22.8 shall affect the right of any holder of a Note to serve process in any manner permitted by law, or limit any right that the holders of any of the Notes may have to bring proceedings against any Credit Party in the courts of any appropriate jurisdiction or to enforce in any lawful manner a judgment obtained in one jurisdiction in any other jurisdiction.

  • 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.

  • NONPAYMENT AND PROCEDURES FOR DISCONNECTION 12.1 If a Party is furnished Interconnection Services under the terms of this Agreement in more than one (1) state, Section 12.2 below through Section 12.19 below, inclusive, shall be applied separately for each such state. 12.2 Failure to pay charges shall be grounds for disconnection of Interconnection Services furnished under this Agreement. If a Party fails to pay any charges billed to it under this Agreement, including but not limited to any Late Payment Charges or Unpaid Charges, and any portion of such Unpaid Charges remain unpaid after the Bill Due Date, the Billing Party will send a Discontinuance Notice to such Non-Paying Party. The Non-Paying Party must remit all Unpaid Charges to the Billing Party within fifteen (15) calendar days of the Discontinuance Notice. 12.3 AT&T-21STATE will also provide any written notification to any Commission as required by any State Order or Rule. 12.4 If the Non-Paying Party desires to dispute any portion of the Unpaid Charges, the Non-Paying Party must complete all of the following actions not later than fifteen (15) calendar days following receipt of the Billing Party’s notice of Unpaid Charges: 12.4.1 notify the Billing Party in writing which portion(s) of the Unpaid Charges it disputes, including the total Disputed Amounts and the specific details listed in Section 13.4 below of this Agreement, together with the reasons for its dispute; and 12.4.2 pay all undisputed Unpaid Charges to the Billing Party; and 12.4.3 pay all Disputed Amounts (other than Disputed Amounts arising from Intercarrier Compensation) into an interest bearing escrow account that complies with the requirements set forth in Section 11.10 above; and 12.4.4 furnish written evidence to the Billing Party that the Non-Paying Party has established an interest bearing escrow account that complies with all of the terms set forth in Section 11.10 above and deposited a sum equal to the Disputed Amounts into that account (other than Disputed Amounts arising from Intercarrier Compensation). Until evidence that the full amount of the Disputed Charges (other than Disputed Amounts arising from Intercarrier Compensation) has been deposited into an escrow account that complies with Section

  • Policies and Procedures i) The policies and procedures of the designated employer apply to the employee while working at both sites. ii) Only the designated employer shall have exclusive authority over the employee in regard to discipline, reporting to the College of Nurses of Ontario and/or investigations of family/resident complaints. iii) The designated employer will ensure that the employee is covered by WSIB at all times, regardless of worksite, while in the employ of either home. iv) The designated employer will ensure that the employee is covered by liability insurance at all times, regardless of worksite, while in the employ of either home. v) The designated employer shall have exclusive authority over the employee’s personnel files and health records. These files will be maintained on the site of the designated employer.

  • Project Implementation The Borrower shall:

  • 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.

  • Performance of Services in Accordance with Regulatory Requirements; Furnishing of Books and Records In performing the services set forth in this Agreement, the Manager: A. shall conform with the 1940 Act and all rules and regulations thereunder, with all other applicable federal, state and foreign laws and regulations, with any applicable procedures adopted by the Trust’s Board of Trustees, and with the provisions of the Trust’s Registration Statement filed on Form N-1A as supplemented or amended from time to time; B. will make available to the Trust, promptly upon request, any of the Fund’s books and records as are maintained under this Agreement, and will furnish to regulatory authorities having the requisite authority any such books and records and any information or reports in connection with the Manager’s services under this Agreement that may be requested in order to ascertain whether the operations of the Trust are being conducted in a manner consistent with applicable laws and regulations.

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