Deviations, Corrective and Preventive Action Systems Sample Clauses

Deviations, Corrective and Preventive Action Systems. 4.4.1. Deviation/failure investigations are handled by GW according to the corresponding Standard Operation Procedures (SOPs). 4.4.2. As GW is responsible for QP release of the product in its primary pack, following testing to the registered Finished Product Specification, GW undertakes to close out satisfactorily all Out of Specification investigations, Deviations and Failures which impact on the batch of Product prior to release. In the case where an OOS, Deviation or Failure cannot be resolved prior to batch release, and has an impact on the Supply Chain forecast, Critical and Major items will be brought to the attention of the QA Department at NOVARTIS within twenty-four (24) hours of identifying that the issue will not be resolved. 4.4.3. Critical and Major deviations - deviations may adversely impact product compliance, product specifications, safety, identity, strength, purity and/or violate GMPs or the product licence shall be reported to NOVARTIS by MANUFACTURER without delay (maximum within twenty-four (24), hours upon discovery or within one business day) and shall include the draft investigation report. Final investigation report shall include a description of the deviation, the results of the investigation on the effect to quality and of the cause, and the corrective action and the preventative action. The conclusions of the investigation report shall be collaboratively assessed with NOVARTIS’ representatives prior to MANUFACTURER final disposition of affected Batches. The Certificate of Analysis (CoA) shall contain references to the Deviation numbers. 4.4.4. As a response to a deviation notification, NOVARTIS may request additional information for further clarification of the deviation and specific points to be considered in the investigation. If NOVARTIS sees an urgent need to have a meeting to discuss such deviations GW shall accommodate NOVARTIS’ request within a reasonable time period, and within the closure period of the investigation to allow for active participation. NOVARTIS and GW shall mutually determine how to handle the relevant Product, NOVARTIS reserves a right to reject concerned batches prior to shipment. 4.4.5. GW shall notify NOVARTIS within one (1) business day of any deviation impacting Product(s) already in NOVARTIS’ possession. Additionally, any issues that could potentially disrupt the supply of NOVARTIS’ Products must be immediately communicated to the contact person (Annex A). 4.4.6. GW is responsible to provide a com...
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Related to Deviations, Corrective and Preventive Action Systems

  • Implementation of Corrective Action Plan After the Corrective Action Plan is finalized, the Purchasers shall use reasonable best efforts to implement the finalized Corrective Action Plan on the timeline set forth therein and provide periodic reports (as provided for therein) to the Sellers on the status of their implementation of the Corrective Action Plan.

  • Environmental, Health and Safety Matters (a) Comply in all material respects with all applicable Environmental Laws, including, without limitation, obtaining and complying with and maintaining any and all licenses, approvals, notifications, registrations or permits required by applicable Environmental Laws. For purposes of this Section 5.12(a), material noncompliance by the Company, any of its Subsidiaries or any tenant or subtenant, with any applicable Environmental Law shall be deemed not to constitute a breach of this covenant provided that, upon learning of any actual or suspected material noncompliance, the Company and the relevant Subsidiaries shall promptly undertake all reasonable efforts to achieve material compliance (or contest in good faith by appropriate proceedings the alleged violation or applicable Environmental Law at issue and (to the extent required by GAAP) provide on the books of the Company or any of its Subsidiaries, as the case may be, reserves in accordance with GAAP with respect thereto), and provided further that, in any case, such noncompliance, and any other noncompliance with applicable Environmental Law, individually or in the aggregate, could not reasonably be expected to have a Material Adverse Effect. (b) Promptly comply in all material respects with all lawful orders and directives of all Governmental Authorities regarding applicable Environmental Laws, except to the extent that the validity thereof is currently being contested in good faith by appropriate proceedings and (to the extent required by GAAP) reserves in accordance with GAAP with respect thereto have been provided on the books of the Company or any of its Subsidiaries, as the case may be. (c) Defend, indemnify and hold harmless the Administrative Agent and the Lenders, and their respective parents, subsidiaries, affiliates, employees, agents, officers and directors, from and against any claims, demands, penalties, fines, liabilities, settlements, damages, costs and expenses of whatever kind or nature, known or unknown, contingent or otherwise, arising out of, or in any way relating to the violation of, noncompliance with or liability under any Environmental Laws applicable to the Company or any of its Subsidiaries or any of their respective operations or properties, or any orders, requirements or demands of Governmental Authorities related thereto, including, without limitation, attorney’s and consultant’s fees, investigation and laboratory fees, response costs, court costs and litigation expenses, except to the extent that any of the foregoing arise out of the gross negligence or willful misconduct of (or, as determined pursuant to a claim initiated by the Company, breach in bad faith of its express obligations under the applicable Loan Documents by) the party seeking indemnification therefor, in each case, as determined by a final non-appealable judgment by a court of competent jurisdiction. This indemnity shall continue in full force and effect regardless of the termination of this Agreement.

  • Mitigation and Corrective Action Business Associate shall mitigate, to the extent practicable, any harmful effect that is known to it of an impermissible use or disclosure of PHI, even if the impermissible use or disclosure does not constitute a Breach. Business Associate shall draft and carry out a plan of corrective action to address any incident of impermissible use or disclosure of PHI. If requested by Covered Entity, Business Associate shall make its mitigation and corrective action plans available to Covered Entity. Business Associate shall require a Subcontractor to agree to these same terms and conditions.

  • Corrective Action Plans If the OAG finds deficiencies in XXXXXXX’s performance under this Grant Contract, the OAG, at its sole discretion, may impose one or more of the following remedies as part of a corrective action plan: increase of monitoring visits; require additional or more detailed financial and/or programmatic reports be submitted; require prior approval for expenditures; require additional technical or management assistance and/or make modifications in business practices; reduce the contract amount; and/or terminate this Grant Contract. The foregoing are not exclusive remedies, and the OAG may impose other requirements that the OAG determines will be in the best interest of the State.

  • Accident Prevention Health and Safety Committee (a) The Employer and the Union agree that they mutually desire to maintain standards of safety and health in the workplace in order to prevent accidents, injury and illness. (b) Recognizing its responsibilities under the applicable legislation, the Employer agrees to accept as a member of its Accident Prevention – Health & Safety Committee at least three (3) representatives, one from each base, selected or appointed by the Union from amongst bargaining unit employees. At any time where a vote is required, an equal number of representatives from each side shall be entitled to vote. (c) Such Committee shall identify potential dangers and hazards, institute means of improving health and safety programs and recommend actions to be taken to improve conditions related to safety and health. (d) The Employee agrees to co-operate reasonably in providing necessary information to enable the Committee to fulfill its functions. (e) Meetings shall be held quarterly or more frequently at the call of the Chair if required. The Committee shall maintain minutes of all meetings and make the same available for review. (f) Any representative appointed or select in accordance with (b) hereof shall serve a term of one (1) calendar year from the date of appointment which may be renewed for further periods of one (1) year. The Union will encourage its representative(s) to serve at least one (1) year. Time off for such representative(s) to attend meetings of the Accident Prevention – Health & Safety Committee in accordance with the foregoing shall be granted and time so spent attending such meetings shall be deemed to be work time for which the representative(s) shall be paid by the Employer at his regular or premium rate as may be applicable. (g) The Union agrees to endeavour to obtain the full co-operation of its membership in the observation of all safety rules and practices. (h) Pregnant employees may request to be transferred from their current duties if, in the professional opinion of the employee’s physician, the pregnancy may be at risk. If such a transfer is not feasible, the pregnant employee, if she so requests, will be granted an unpaid leave of absence before commencement of the maternity leave referred to in Article 16.04

  • Corrective Action Plan Within fifteen (15) Business Days following the establishment of the Joint Remediation Committee, the Purchasers, in consultation with the Sellers, shall prepare and submit to the Joint Remediation Committee an initial draft of the Corrective Action Plan. The parties shall work in good faith through the Joint Remediation Committee to finalize the Corrective Action Plan within fifteen (15) Business Days of the Purchasers’ submission of the initial draft of the Correct Action Plan. At the end of such period, if the Sellers reasonably determine that the Corrective Action Plan proposed by the Purchasers (as may be modified over the course of such period) would not reasonably be expected to satisfactorily address the Major Default, then the Sellers may escalate the issue to the Head of Commercial Capital (or equivalent leader of any successor business unit) of the Seller Group and the Chief Executive Officer of the Bank Assets Purchaser (the “Senior Executives”) and the Senior Executives shall work collaboratively (including with the Joint Remediation Committee) to develop a mutually agreeable Corrective Action Plan within fifteen (15) Business Days.

  • Corrective Actions The Government will use its best efforts to ensure that each Covered Provider (i) takes, where necessary, appropriate and timely corrective actions in response to audits, (ii) considers whether the results of the Covered Provider’s audit necessitates adjustment of the Government’s records, and (iii) permits independent auditors to have access to its records and financial statements as necessary.

  • Environmental Health and Safety i. Environment, Health and Safety Performance. Seller acknowledges and accepts full and sole responsibility to maintain an environment, health and safety management system ("EMS") appropriate for its business throughout the performance of this Contract. Buyer expects that Seller’s EMS shall promote health and safety, environmental stewardship, and pollution prevention by appropriate source reduction strategies. Seller shall convey the requirement of this clause to its suppliers. Seller shall not deliver goods that contain asbestos mineral fibers.

  • Health and Safety Plan Consultant shall prepare and submit a Health and Safety Plan (“HASP”) for the portion of Consultant’s work that will involve field work, assessments, or investigations of certain Project elements. The HASP shall describe how Consultant plans to complete field work, assessments, and/or investigations at the RWF. Consultant’s HASP must comply with the CIP HASP and shall be updated as new conditions are encountered.

  • Workplace Violence Prevention and Crisis Response (applicable to any Party and any subcontractors and sub-grantees whose employees or other service providers deliver social or mental health services directly to individual recipients of such services): Party shall establish a written workplace violence prevention and crisis response policy meeting the requirements of Act 109 (2016), 33 VSA §8201(b), for the benefit of employees delivering direct social or mental health services. Party shall, in preparing its policy, consult with the guidelines promulgated by the U.S. Occupational Safety and Health Administration for Preventing Workplace Violence for Healthcare and Social Services Workers, as those guidelines may from time to time be amended. Party, through its violence protection and crisis response committee, shall evaluate the efficacy of its policy, and update the policy as appropriate, at least annually. The policy and any written evaluations thereof shall be provided to employees delivering direct social or mental health services. Party will ensure that any subcontractor and sub-grantee who hires employees (or contracts with service providers) who deliver social or mental health services directly to individual recipients of such services, complies with all requirements of this Section.

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