Qualification and Validation Sample Clauses

Qualification and Validation. LONZA shall be responsible for validating the LONZA Equipment used for supply of Product or, if applicable, performance of the Services (including conducting installation, operational and performance qualification), and the production, cleaning and, to the extent applicable, packaging processes, as well as all other appropriate steps performed at the Facilities. All activities and procedures must: (i) meet applicable regulatory requirements; and (ii) be found acceptable by Regulatory Authority inspectors, if applicable. If any Regulatory Authority finds LONZA’s validation procedures to be unacceptable, then LONZA will take (or have taken) appropriate remedial measures, including repeating the validation as necessary, such that the validation procedures meet all applicable regulatory requirements and guidelines, including those necessary to receive all Regulatory Authority approvals. If any of LONZA’s validation procedures fail to comply with cGMP or the Specifications, LONZA shall promptly remedy such failure in order to comply with all cGMP and Specifications. Furthermore, LONZA shall also be responsible for validating the MODERNA Equipment under the terms set forth above when agreed upon in the relevant Statement of Work.
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Qualification and Validation. Agilent will be responsible for the qualification and validation of manufacturing and testing equipment and processes, as mutually defined by Agilent and Ophthotech.
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Qualification and Validation. The following qualification and validation activities are included in the Base Fee, and only relates to the 20ml vial.
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Qualification and Validation. NOVARTIS agrees that manufacturing, in-process and quality control, and cleaning procedures must be validated and carried out under cGMP rules. Furthermore, the manufacturing instructions shall be followed using calibrated and qualified equipment, computer systems and machines.
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Qualification and Validation. Qualification and validation consist of pre-defined and pre-approved protocols to assess the defined parameters of a specified test procedure, or production method. Qualification provides documented data that assesses the suitability of a specified test procedure, or production method for its intended purpose, and validation provides documented evidence that a test procedure, or production method is suitable (within pre-defined parameters) for its intended purpose. Validation reports are the output of an executed validation protocol.
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Qualification and Validation. The ACCEPTOR agrees that the distribution system used must be validated. Furthermore, the documentation as laid down in the specifications shall be followed, using calibrated and qualified equipment, computer systems and machines.
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Qualification and Validation a. AVECIA will perform appropriate installation qualification (IQ), operational qualification (OQ), and/or performance qualification (PQ) for the required classes of equipment used and process used for the production and control of AGU. Evaluation and/or re-validation will be conducted in accordance with appropriate specifications/ procedures. X Confirm in audit b. Documentation of such activities and/or schedule of revalidation shall be the responsibility of AVECIA. X Confirm in audit c. Documentation shall be available to DYNAVAX or partners, upon mutual agreement with AVECIA, or Regulatory Authorities upon request. X
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Related to Qualification and Validation

  • Qualification and Good Standing Each Loan Party is qualified to do business and in good standing in every jurisdiction where its assets are located and wherever necessary to carry out its business and operations, except in jurisdictions where the failure to be so qualified or in good standing has not had and will not have a Material Adverse Effect.

  • Qualifications of Panelists All Panelists shall: (a) have expertise or experience in law, international trade, other matters covered by this Agreement, or the resolution of disputes arising under international trade agreements relevant to the subject matter of the dispute; (b) be chosen strictly on the basis of objectivity, impartiality, reliability, and sound judgment; (c) be independent of, and not be affiliated with or take instructions from, any Party; (d) not delegate their responsibilities to any other person; and (e) comply with the Model Rules of Procedure established in Annex 12 (Model Rules of Procedure).

  • QUALIFICATION OF BIDDERS BID PACKAGE REQUIREMENTS:

  • Election and Term of Office The officers of the Company shall be elected from time to time by the Board. Each officer shall hold office until such person’s successor shall have been duly elected and qualified or until such person’s death or until he or she shall resign or be removed pursuant to Section 6.8.

  • STAFF QUALIFICATIONS CONTRACTOR shall ensure that all individuals employed, contracted, and/or otherwise hired by CONTRACTOR to provide classroom and/or individualized instruction or related services hold a license, certificate, permit, or other document equivalent to that which staff in a public school are required to hold in the service rendered consistent with Education Code section 56366.1(n)(1) and are qualified pursuant to Title 34 of the Code of Federal Regulations sections 200.56 and 200.58, and Title 5 of the California Code of Regulations sections 3001(y), 3064 and 3065. Such qualified staff may only provide related services within the scope of their professional license, certification or credential and ethical standards set by each profession, and not assume responsibility or authority for another related services provider or special education teacher’s scope of practice. CONTRACTOR shall ensure that all staff are appropriately credentialed to provide instruction and services to students with the disabling conditions placed in their program/school through documentation provided to the CDE (5 CCR 3064 (a)).

  • Qualification to do Business Each of the Company and its Subsidiaries is duly qualified to do business as a foreign corporation, limited liability company or partnership (as the case may be) and is in good standing or similar concept in every jurisdiction in which the character of the properties owned or leased by it or the nature of the business conducted by it makes such qualification necessary, except where the failure to be so qualified or in good standing would not, individually or in the aggregate, have a Company Material Adverse Effect.

  • Qualifications for Voting To be entitled to vote at any meeting of Holders a Person shall (a) be a Holder of one or more Notes on the record date pertaining to such meeting or (b) be a Person appointed by an instrument in writing as proxy by a Holder of one or more Notes on the record date pertaining to such meeting. The only Persons who shall be entitled to be present or to speak at any meeting of Holders shall be the Persons entitled to vote at such meeting and their counsel and any representatives of the Trustee and its counsel and any representatives of the Company and its counsel.

  • Due Qualification and Good Standing The Borrower is in good standing in the State of Delaware. The Borrower is duly qualified to do business and, to the extent applicable, is in good standing in each other jurisdiction in which the nature of its business, assets and properties, including the performance of its obligations under this Agreement, the other Facility Documents to which it is a party and its Constituent Documents, requires such qualification, except where the failure to be so qualified or in good standing could not reasonably be expected to have a Material Adverse Effect.

  • Organization and Good Standing; Qualification The Seller has been duly organized and is validly existing as a limited liability company in good standing under the laws of the State of Delaware, with the power and authority to own or lease its properties and to conduct its activities as such properties are currently owned or leased and such activities are currently conducted.

  • Professional Qualifications It shall be a condition of continued professional employment that employees must apply for enrolment in their appropriate professional licensing body by the thirtieth day of continuous service.

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