Quality Assurance Audit Sample Clauses

Quality Assurance Audit. Inspection‌ To ensure compliance with GCP and all applicable regulatory requirements, Galderma Laboratories, L.P. may conduct a quality assurance audit of the site records, and the regulatory agencies may conduct a regulatory inspection at any time during or after completion of the study. The investigator must agree to grant the auditor(s) and inspector(s) direct access to all relevant documents and to allocate their time and the time of their staff to discuss any findings/relevant issues.
Sample 1Sample 2
AutoNDA by SimpleDocs
Quality Assurance Audit. Heska agrees that upon a minimum fifteen (15) days notice from i-STAT, representatives of i-STAT, during normal business hours, shall be permitted to visit all locations where Heska maintains inventory of Products to conduct a quality assurance audit of such facilities and/or an on-site surveillance of the inventory storage tracking. i-STAT shall have the right during reasonable business hours, to inspect the books and records of Heska relating to Product complaint documentation. In the event that an audit reveals items that i-STAT determines should be corrected by Heska, i-STAT shall provide, in writing, within thirty (30) days of such audit, a list of such items and any proposed corrective action to be taken by Heska. Heska shall respond within fifteen (15) days of receiving i-STAT's notification of the corrective action to be taken and an estimated completion date. If the parties disagree as to whether corrective action is necessary, the matter shall be resolved in accordance with the alternative dispute resolution procedures set forth in Section 11.9.
Sample 1
Quality Assurance Audit. Seller shall adhere to standard commercial practices in providing Goods. However, if there are any unique requirements, such as FFA or U.S. Government specifications required, the parties must mutually agree on such and specify on the face of an Order. With respect to quality, engineering, and manufacturing purposes only, Seller shall provide Buyer, Buyer’s customer, and U.S. Government or other regulatory agencies the right, upon reasonable written notice, to access and perform any inspection, test, audit, or investigation at Seller’s premises to verify compliance with the requirements of an Order. Notwithstanding the foregoing, Seller will not be required to provide any of the foregoing parties with any business or financial related data, records, or other information.
Sample 1
Quality Assurance Audit. 1.1 AVL agrees that a Quality Assurance (“QA”) auditor to be selected by Adherex will be granted reasonable access to AVL’s facilities to conduct a QA audit at Adherex’s sole expense to evaluate the suitability of the Published Data for submission to the U.S. Food and Drug Administration or other equivalent regulatory agencies worldwide (the “QA Audit”). 1.2 Adherex shall agree in good faith with Prof. dr A.J.M. Balm of AVL when the QA Audit will be performed. The QA Audit is not expected to last longer then three (3) working days. 1.3 Adherex shall not use any confidential or proprietary AVL data, know-how, or information, or any part of it, obtained as a result of the QA Audit (the “QA Results”) for any purpose other than the evaluation of whether Adherex wishes to obtain the exclusive license to use the Licensed Data hereunder, and Adherex agrees that it and its representatives, employees and agents will maintain in strict confidence all QA Results and not use such QA Results for any other purpose than the QA Audit unless and until Adherex has provided the Notice and has received a confirmation thereof from AVL as set forth in Article 1.5 below. For greater certainty, this provision will not in any way limit Adherex’s ability to refer to or use any data that have been previously published and which are in the public domain. 1.4 Adherex will ensure that the auditor selected for the QA Audit agrees to abide by the terms of confidentiality and non-use outlined in Article 1.3 above and that the QA Results will not be copied or taken from the AVL facilities unless otherwise approved in writing by AVL. 1.5 No later than [*] weeks after the completion of the QA Audit, Adherex will give AVL written notice stating whether Adherex wishes to obtain an exclusive license in accordance with the terms and conditions of this Agreement (the “Notice”). AVL shall confirm the receipt of such Notice without undue delay. The Notice shall be provided to: NKI-AVL Technology Transfer Office , Room DC208 Attn. Mr. J. van der Hel, legal Adviser Plesmanlaan 121 1066 CX Amsterdam [*] Confidential treatment requested; certain information omitted and filed separately with the SEC.
Sample 1
Quality Assurance Audit. Lumara, at its own expense, shall have the right to conduct quality assurance audits with respect to all facilities, operations, and laboratories where work under this Agreement is conducted by Antares, or on its behalf by subcontractors, (including, without limitation, work conducted by Antares related to the Device Development Plan) and to verify Antares' conformance with applicable cGMP, cGLP, cGCP, cQSRs and other regulatory requirements including, without limitation, verifying appropriate inventory control and material accountability systems with respect to the Device, Prefilled Syringes and Products. Such audits shall only be conducted upon reasonable notice during business hours. [***]. TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED
Sample 1
Quality Assurance Audit. Lilly, at its own expense, shall have the right to conduct quality assurance audits with respect to all facilities, operations, and laboratories where work under this Agreement is conducted by Antares, or on its behalf by subcontractors, (including, without limitation, work conducted by Antares related to the Device Development Plan) and to verify Antares’ conformance with applicable cGMP, cGLP, cGCP, cQSRs and other regulatory requirements including, without limitation, verifying appropriate inventory control and material accountability systems with respect to the Device. Such audits shall only be conducted upon reasonable notice during business hours. Antares shall make necessary changes as required by such audit based on an action plan agreed to by the Parties. ***-Denotes portions omitted pursuant to a request for confidentiality under Rule 24b-2 of the Securities Exchange Act of 1934. A copy of this agreement with the omitted information intact has been filed separately with the Securities and Exchange Commission.
Sample 1
Quality Assurance Audit. (a) ZGEN will have the right to conduct reasonable quality assurance audits with respect to all facilities, clinical sites, operations and laboratories (and any records related thereto) operated by Bayer or its Third Party subcontractors where Development or manufacturing activities for Licensed Product are conducted, including the right to audit activities that formed the basis of CMC documentation; provided, however, that such audits shall be conducted not more than once in any [ * ] ([ * ]) month period, other than “for cause” audits conducted in follow-up to findings of material deficiencies or critical observations made during previous audits, and such audits shall be limited to those portions of such facilities, clinical sites, operations, laboratories and records as are actually used for or related to Development or manufacturing activities for Licensed Product. All audits initiated by ZGEN will be conducted at ZGEN’s sole expense, upon reasonable prior notice to Bayer during regular business hours, and shall be subject to the confidentiality obligations of Article 14. (b) Bayer will have the right to conduct reasonable quality assurance audits with respect to all facilities, clinical sites, operations and laboratories (and any records related thereto) operated by ZGEN or its Third Party contractors where Development or manufacturing activities for Licensed Product are conducted, including the right to audit activities that formed the basis of CMC documentation; provided, however, that such audits shall be conducted not more than once in any [ * ] ([ * ]) month period, other than “for cause” audits conducted in follow-up to findings of material deficiencies or critical observations made during previous audits, and such audits shall be limited to those portions of such facilities, clinical sites, operations, laboratories and records as are actually used for or related to Development or manufacturing activities for Licensed Product. All audits initiated by Bayer will be conducted at Bayer’s sole expense, upon reasonable prior notice to ZGEN during regular business hours, and shall be subject to the confidentiality obligations of Article 14. (c) The Alliance Managers or JDC Team Leaders, as appropriate, shall facilitate and coordinate visits under this Section 6.4 and each Party shall use commercially reasonable efforts to accommodate such a visit by the other Party, including providing the individuals visiting with access to all relevant portions of t...
Sample 1
AutoNDA by SimpleDocs
Quality Assurance Audit. Evidence showing that the Pharmacy staff have appropriate skills, knowledge and that they are up to date must be provided to Solutions4Health. Entries on PharmOutcomes must be accurate and reflect the nature of the consultation held. Number of safeguarding referrals will be retained in the Pharmacy for monitoring purposes. If there are any quality issues regarding the service delivered, Herefordshire ISHS will work with the pharmacy to improve outcomes and performance. The Pharmacy will be able to refer to the specialist service for further management of sexual health needs, which will include pathways for young and vulnerable people. All pharmacies must record all EHC consultations and prescriptions, using PharmOutcomes, including: Date of Consultation Client’s Date of Birth Client’s Postcode Completed EHC Consultation Form Exclusion form where appropriate and onward referral Solutions 4 Health will agree a timetable for regular monitoring meetings with each pharmacy, in order to review the performance of the contract. In keeping with the audit requirements set out in the PGD, an audit will be carried out within the first year, with subsequent re-audits to be agreed. The audit should include at least 20 sets of patient notes or 50% (whichever is smaller). A summary of the audit should be sent to the appropriate person as per Solutions4Health/PGD policy.
Sample 1
Quality Assurance Audit. Nuvelo will have the right to conduct reasonable quality assurance audits with respect to all facilities, operations and laboratories (and any records related thereto) operated by Bayer or its Third Party subcontractors, where Development activities are conducted, as is reasonably necessary solely for the purpose of verifying Bayer’s conformance with applicable GMP, GLP, GCP and other regulatory requirements in each country in the Bayer Territory. All audits initiated by Nuvelo will be conducted at Nuvelo’s sole expense, upon reasonable prior notice to Bayer, and during regular business hours. Bayer will have the right to conduct reasonable quality assurance audits with respect to all facilities, operations and laboratories (and any records related thereto) operated by Nuvelo or its Third Party contractors where Development or manufacturing activities for Licensed Product are conducted, including the right to audit activities that formed the basis of CMC documentation, only to the extent reasonably necessary for Bayer to carry out its Development and Commercialization obligations hereunder and as is reasonably necessary solely for the purpose of verifying Nuvelo’s conformance with applicable GMP, GLP, GCP and other regulatory requirements in the Nuvelo Territory. All audits initiated by Bayer will be conducted at Bayer’s sole expense, upon reasonable prior notice to Nuvelo, and during regular business hours.
Sample 1

Related to Quality Assurance Audit

  • 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.

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

  • 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.

  • Compliance Audit LEA shall have the right but shall be under no obligation to conduct audit(s), from time to time, of Provider’s records concerning its compliance obligations as set forth in this Article V. Provider shall make such records and other documents available to LEA upon request.

  • Contractual and Operational Compliance Audits (a) ICANN may from time to time (not to exceed twice per calendar year) conduct, or engage a third party to conduct, contractual compliance audits to assess compliance by Registry Operator with its representations and warranties contained in Article 1 of this Agreement and its covenants contained in Article 2 of this Agreement. Such audits shall be tailored to achieve the purpose of assessing compliance, and ICANN will (a) give reasonable advance notice of any such audit, which notice shall specify in reasonable detail the categories of documents, data and other information requested by ICANN, and (b) use commercially reasonable efforts to conduct such audit during regular business hours and in such a manner as to not unreasonably disrupt the operations of Registry Operator. As part of such audit and upon request by ICANN, Registry Operator shall timely provide all responsive documents, data and any other information reasonably necessary to demonstrate Registry Operator’s compliance with this Agreement. Upon no less than ten (10) calendar days notice (unless otherwise agreed to by Registry Operator), ICANN may, as part of any contractual compliance audit, conduct site visits during regular business hours to assess compliance by Registry Operator with its representations and warranties contained in Article 1 of this Agreement and its covenants contained in Article 2 of this Agreement. ICANN will treat any information obtained in connection with such audits that is appropriately marked as confidential (as required by Section 7.15) as Confidential Information of Registry Operator in accordance with Section 7.15.

  • Compliance Audits D. 4.1 Compliance Audit(s). Without limiting the generality of section A.7.4 (Records Review), if requested by the Province from time to time, which request shall be at the Province’s sole discretion, the Recipient, at its own expense, will forthwith retain an independent third party auditor to conduct one or more compliance audits of the Recipient or any Project. The audit will be conducted in accordance with Canadian Generally Accepted Auditing Standards, as adopted by the Canadian Institute of Chartered Accountants, applicable as of the date on which a record is kept or required to be kept under such standards. In addition, the audit will assess the Recipient’s compliance with the terms of the Agreement and will address, with respect to each Project, without limitation, the following: (a) whether the Funds were spent in accordance with the Agreement and with due regard to economy, efficiency, and effectiveness; (b) the Project’s progress or state of completion; (c) whether the financial information the Recipient provided is complete, accurate, and timely, and in accordance with the Agreement; (d) whether the Recipient’s information and monitoring processes and systems are adequate to identify, capture, validate, and monitor the achievement of intended benefits of the Project; (e) the overall management and administration of the Project; (f) recommendations for improvement or redress; and (g) whether prompt and timely corrective action is taken on prior audit findings.

  • 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.

  • 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.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!