Quality Assurance, Etc Sample Clauses

Quality Assurance, Etc. (a) ORTHO shall have day to day responsibility for commercial manufacturing and formulation issues related to product safety and regulatory compliance. ERGO shall provide technical support reasonably required by ORTHO or Third Parties for the manufacture of Collaboration Products. The costs of providing on-going post-launch technical support shall be an Allowable Expense under Post- Launch Product R & D Expense as defined in Exhibit A. Regardless of the parties selected to manufacture the Collaboration Products for the Profit/Loss Sharing Territory, each of the Parties shall have rights of inspection and audit as set forth in the contract with such Third Party to enable it to comply with its internal quality assurance and reporting obligations, including those imposed by regulatory authorities. In addition, before a final commitment is made to any Party or Parties or to any Third Party regarding manufacturing plant decisions for the supply of Collaboration Products to the Profit/Loss Sharing Territory, both Parties shall have the right to perform plant quality assurance audits. (b) All Collaboration Compounds and Products used in clinical and commercial supplies will be manufactured, tested, and released according to current CGMP's. It is expected that the manufacturer will be responsible for maintaining their facilities and procedures, including those of Third Parties, in compliance with CGMP's. ORTHO has the right to perform periodic assessments of CGMP compliance by inspection of facilities for the manufacture of Collaboration Compounds for use in clinical and commercial supplies, for the manufacture of Collaboration products and active ingredients for use in clinical and commercial supplies, and review of compliance related documents. If CGMP deficiencies should be identified by ORTHO, the manufacturer will receive written notification from ORTHO describing the specific compliance issues identified. The manufacturer has an obligation to establish a corrective action plan within 30 days of receiving notice of such deficiencies from ORTHO. The corrective action plan will establish clear goals and timing for improvement of specific compliance issues and must be agreed to by ORTHO. Any expenses incurred in improving compliance will be the full responsibility of the manufacture. In the event that ORTHO's compliance assessment challenges the suitability of any particular batch of clinical or commercial materials intended for clinical or commercial use, ORTHO...
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Related to Quality Assurance, Etc

  • Quality Assurance The parties endorse the underlying principles of the Company’s Quality Management System, which seeks to ensure that its services are provided in a manner which best conforms to the requirements of the contract with its customer. This requires the Company to establish and maintain, implement, train and continuously improve its procedures and processes, and the employees to follow the procedures, document their compliance and participate in the improvement process. In particular, this will require employees to regularly and reliably fill out documentation and checklists to signify that work has been carried out in accordance with the customer’s specific requirements. Where necessary, training will be provided in these activities.

  • Quality Assurance Program An employee shall be entitled to leave of absence without loss of earnings from her or his regularly scheduled working hours for the purpose of writing examinations required by the College of Nurses of Ontario arising out of the Quality Assurance Program.

  • Quality Assurance/Quality Control Contractor shall establish and maintain a quality assurance/quality control program which shall include procedures for continuous control of all construction and comprehensive inspection and testing of all items of Work, including any Work performed by Subcontractors, so as to ensure complete conformance to the Contract with respect to materials, workmanship, construction, finish, functional performance, and identification. The program established by Contractor shall comply with any quality assurance/quality control requirements incorporated in the Contract.

  • COUNTY’S QUALITY ASSURANCE PLAN The County or its agent will evaluate the Contractor’s performance under this Contract on not less than an annual basis. Such evaluation will include assessing the Contractor’s compliance with all Contract terms and conditions and performance standards. Contractor deficiencies which the County determines are severe or continuing and that may place performance of the Contract in jeopardy if not corrected will be reported to the Board of Supervisors. The report will include improvement/corrective action measures taken by the County and the Contractor. If improvement does not occur consistent with the corrective action measures, the County may terminate this Contract or impose other penalties as specified in this Contract.

  • Quality Assurance Requirements There are no special Quality Assurance requirements under this Agreement.

  • Quality Management Grantee will: 1. comply with quality management requirements as directed by the System Agency. 2. develop and implement a Quality Management Plan (QMP) that conforms with 25 TAC § 448.504 and make the QMP available to System Agency upon request. The QMP must be developed no later than the end of the first quarter of the Contract term. 3. update and revise the QMP each biennium or sooner, if necessary. Xxxxxxx’s governing body will review and approve the initial QMP, within the first quarter of the Contract term, and each updated and revised QMP thereafter. The QMP must describe Xxxxxxx’s methods to measure, assess, and improve - i. Implementation of evidence-based practices, programs and research-based approaches to service delivery; ii. Client/participant satisfaction with the services provided by Xxxxxxx; iii. Service capacity and access to services; iv. Client/participant continuum of care; and v. Accuracy of data reported to the state. 4. participate in continuous quality improvement (CQI) activities as defined and scheduled by the state including, but not limited to data verification, performing self-reviews; submitting self-review results and supporting documentation for the state’s desk reviews; and participating in the state’s onsite or desk reviews. 5. submit plan of improvement or corrective action plan and supporting documentation as requested by System Agency. 6. participate in and actively pursue CQI activities that support performance and outcomes improvement. 7. respond to consultation recommendations by System Agency, which may include, but are not limited to the following: i. Staff training; ii. Self-monitoring activities guided by System Agency, including use of quality management tools to self-identify compliance issues; and iii. Monitoring of performance reports in the System Agency electronic clinical management system.

  • Quality Management System Supplier hereby undertakes, warrants and confirms, and will ensue same for its subcontractors, to remain certified in accordance with ISO 9001 standard or equivalent. At any time during the term of this Agreement, the Supplier shall, if so instructed by ISR, provide evidence of such certifications. In any event, Supplier must notify ISR, in writing, in the event said certification is suspended and/or canceled and/or not continued.

  • Evaluation, Testing, and Monitoring 1. The System Agency may review, test, evaluate and monitor Grantee’s Products and services, as well as associated documentation and technical support for compliance with the Accessibility Standards. Review, testing, evaluation and monitoring may be conducted before and after the award of a contract. Testing and monitoring may include user acceptance testing. Neither the review, testing (including acceptance testing), evaluation or monitoring of any Product or service, nor the absence of review, testing, evaluation or monitoring, will result in a waiver of the State’s right to contest the Grantee’s assertion of compliance with the Accessibility Standards. 2. Grantee agrees to cooperate fully and provide the System Agency and its representatives timely access to Products, records, and other items and information needed to conduct such review, evaluation, testing, and monitoring.

  • Research Analyst Independence The Company acknowledges that the Underwriters’ research analysts and research departments are required to be independent from their respective investment banking divisions and are subject to certain regulations and internal policies, and that such Underwriters’ research analysts may hold views and make statements or investment recommendations and/or publish research reports with respect to the Company and/or the offering that differ from the views of their respective investment banking divisions. The Company hereby waives and releases, to the fullest extent permitted by law, any claims that the Company may have against the Underwriters with respect to any conflict of interest that may arise from the fact that the views expressed by their independent research analysts and research departments may be different from or inconsistent with the views or advice communicated to the Company by such Underwriters’ investment banking divisions. The Company acknowledges that each of the Underwriters is a full service securities firm and as such from time to time, subject to applicable securities laws, may effect transactions for its own account or the account of its customers and hold long or short positions in debt or equity securities of the companies that may be the subject of the transactions contemplated by this Agreement.

  • Money Market Fund Compliance Testing and Reporting Services Subject to the authorization and direction of the Trust and, in each case where appropriate, the review and comment by the Trust’s independent accountants and legal counsel, and in accordance with procedures that may be established from time to time between the Trust and the Administrator, the Administrator will:

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