Quality Assurance Audits. Vendor shall cooperate with the Board in conducting quality assurance audits as determined appropriate by the Board. Scheduled audits will be planned at least thirty (30) days in advance and Vendor shall ensure that all vehicles are available for inspection. Vendor’s failure to have a vehicle available on the scheduled audit date shall result in the vehicle immediately being removed from servicing Board’s runs. Vehicles will not be returned to service until one of the two following requirements is met:
Quality Assurance Audits. Permittee shall perform quality assurance audits on itself on at least a quarterly basis, as described on attached Exhibit “14”. Port reserves the right to prescribe and revise the audit criteria at any time. The purpose of said audits shall be to ensure consistent standards of Permittee’s customer service and quality.
Quality Assurance Audits. Concessionaire shall perform quality assurance audits with respect to the operations at each Unit and the Premises and compliance with the terms of this Agreement on at least a quarterly basis. CEO reserves the right to prescribe and revise audit criteria at any time and from time to time and to publish guidelines to be used in connection with such audits. The purpose of such audits shall be to ensure consistent high standards of customer service and quality among concessionaires at the Airport. In addition, Concessionaire hereby agrees to participate in and to comply with the requirements and recommendations of City- implemented 'mystery shopper' and other quality assurance programs. At CEO's request, but no more often than once per quarter, Concessionaire shall (a) meet with City, (b) make available for inspection all customer survey results, mystery shopper reports, health department reports, product pricing, and such quality assurance audits, (c) review the results of any City- implemented 'mystery shopper' and other quality assurance programs, and (d) review and develop a plan to implement recommendations for corrective action if such information shows corrective action is needed. If such information discloses any issue, in the sole discretion of CEO, then, upon CEO's written request, Concessionaire shall submit for CEO's approval an outline of planned corrective action and the implementation of any additional reports or procedures to document compliance and implementation of such planned corrective action. Once approved, Concessionaire shall implement such planned corrective action and deliver reasonably satisfactory evidence of such compliance to City in accordance with such corrective action plan.
Quality Assurance Audits. The quality assurance organization shall establish and maintain a quality control audit program. Records of this program shall be subject to review by the TRIPS.
Quality Assurance Audits. ISIS will perform inspections of its facilities to review its manufacturing operations and assess its compliance with cGMP. In addition, upon LILLY's written request and at mutually agreeable times during normal business hours, ISIS will permit representatives of LILLY to review ISIS' manufacturing operations and records and assess its compliance with cGMP and quality assurance standards and to discuss any manufacturing issues with ISIS' manufacturing and management personnel. Under the Production and Delivery Plan, LILLY will have notice of how many production runs ISIS may conduct in a given Calendar Year, which will permit LILLY personnel to observe any such production run, if LILLY so chooses, after providing notice to ISIS (and at its own expense). In the event of a regulatory inspection that directly involves the API, ISIS will immediately inform LILLY of the issuance of the Notice of Inspection (or an equivalent notice from a non-U.S. Regulatory Authority) will provide LILLY with copies of all communications relating thereto and LILLY will be allowed to participate.
Quality Assurance Audits. (a) DO, at its own expense and at its sole discretion, shall have reasonable access during regular business hours, upon prior written notice of not less than ten (10) business days, to the Product Inspection and Acceptance Location(s) where the Products are being manufactured in order to monitor and audit the manufacturing practices for the Products as necessary to ensure satisfaction of the regulatory compliance provisions of this Agreement including FDA QSR and GMP requirements, and, in accordance with paragraph 10 of Section III, to inspect and accept the Products prior to shipping. During such audit or inspection for acceptance, CCSI agrees that either CCSI or its third-party manufacturer of the Products shall, upon written request from DO, promptly make available to DO, for its review but not for copying, the entire DMR documents, including the master document (as amended from time to time) redacted to exclude proprietary information of CCSI and of its third-party manufacturer not needed for such audit or inspection, as follows: the exclusion of the detailed description of parts specifications for Light Emitting Diodes, * for Light Emitting Diodes, optical filters, light sources, calibration color standards, verification color standards and integrated circuit boards, and the specific description in all software documentation (including the Technical File and Design Control documentation) of the algorithms, mathematical formulas or equations, or any other computations or specific descriptions of software code where the specific descriptions are related to the color measurement, the skin color * the adjustments for skin coloration (including under phototherapy) baseline skin coloration, measurement of proprietary standards, computation of spectral data, computation of * data, conversion formulas for spectral and * data, equations for power source, * equations, site computations, * signals and * parameters. CCSI agrees to provide DO with prior written notice of any change in CCSI's third-party manufacturer of the Products, which notice shall identify the name and location of any such manufacturer.
Quality Assurance Audits. Each Party shall be responsible for establishing audit plans for each Clinical Study assigned to it in the GDPs according to its internal SOPs. The JDC (or its chosen Subteam) shall review and provide comments on the audit plans established by Licensee and Genmab’s quality assurance personnel. Licensee and Genmab’s quality assurance personnel will each consider in good faith all such comments submitted by the Joint Regulatory Subteam, but Licensee and [*] = Certain information contained in this document, marked by brackets, has been omitted because it is both not material and is the type of information that we treat as private or confidential. Genmab’s quality assurance personnel shall each have final decision-making authority with respect to the audit plans it develops.
Quality Assurance Audits. Licensee’s quality assurance department will be responsible for establishing audit plans for the Development activities assigned to Licensee with respect to any Shared Clinical Trial, and Post-Approval Marketing Studies according to Licensee’s internal SOP. Licensor’s quality assurance department will be responsible for establishing audit plans for the Development activities assigned to Licensor with respect to any Shared Clinical Trial, ongoing Clinical Trials and Post-Approval Marketing Studies according to Licensor’s internal SOP. The JSC shall form a joint Oversight/Quality Working Group (the “Oversight/Quality Working Group”) and such Oversight/Quality Working Group may review and provide comments on the audit plans established by Licensee’s and Licensor’s quality assurance personnel. Licensee’s and Licensor’s quality assurance personnel will each consider in good faith all such comments submitted by the Oversight/Quality Working Group, but Licensee’s and Licensor’s quality assurance personnel shall each have final decision-making authority with respect to the audit plans it develops.
Quality Assurance Audits. During the Project Term, Lilly retains the right at reasonable times and upon reasonable prior written notice to conduct quality assurance audits on SIBIA's research and development facilities, as well as the facilities of any subcontractors of SIBIA performing subcontracts, where work on the Project is conducted, as reasonably deemed necessary by Lilly in order to ensure that such facilities meet Lilly and regulatory authority standards. SIBIA hereby agrees to cooperate with Lilly and take such other acts as may be reasonably necessary or appropriate to carry out the purpose and intent of this Section 3.4 of this Agreement.
Quality Assurance Audits. Contractor shall cooperate with the School in conducting quality assurance audits as determined appropriate by the School. Quality Assurance Audits will be scheduled at least one week in advance. Unscheduled audits and inspections shall be conducted by the School as the need warrants. Inspection of vehicles by the School shall be an integral part of the audits.
