Qualification Run definition

Qualification Run means a Run used to document the operability and ----------------- reproducibility of the Manufacturing Process at the Genentech Facility, and is described in Section 3.7(b) hereof. --------------
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Qualification Run means a Run used to document the operability and
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Qualification Run means a Run conducted (i) to demonstrate and document the consistency and reproducibility of the Manufacturing Process at the Facility, (ii) to establish the comparability of the Product manufactured therefrom to Herceptin manufactured by Genentech as required by the FDA and (iii) to support licensure of both the Facility and the Manufacturing Process at the Facility under the sBLA. Each Qualification Run must be produced from an inoculation of the [*], all in accordance with cGMP and the Manufacturing Documentation.
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Examples of Qualification Run in a sentence

  • Rules for the FIS Alpine Points Limit of parallel competitions4.4.10 FIS points for the Qualification Run FIS points will be calculated for the European Cup KO and Parallel qualification run.

  • The following proposals for the Parallel Qualification Run to be held at the 2021 World Championships in Cortina d´Ampezzo were approved.Rules for the Qualification Race for Parallel EventQualification races will take place for women and men’s Parallel.


More Definitions of Qualification Run

Qualification Run means a Run used to document the operability and reproducibility of the Manufacturing Process at the Lonza Facility, and is described in Section 4.4.2 hereof.
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Related to Qualification Run

  • Qualification Date means the date as of which the Offering Statement was or will be qualified with the Commission pursuant to Regulation A, the Act and the Rules and Regulations; and

  • Qualification Period means the period of time in which the List of Approved Suppliers shall be valid in accordance with the Tender; in which the Company shall have the right, at any time to issue Purchase Order(s) for Goods and/or to approach any or all of the Approved Suppliers and invite them, by way of RFQ to supply Goods, all in accordance with the terms and conditions of the Contract.

  • Qualification Requirements means the qualification requirements as set forth in Section-2, Clause 2.1 of this RFP;

  • Prequalification means the process set out in the Rules for determining whether an applicant is eligible to bid in a capacity auction in respect of a CMU;

  • Qualification Deadline has the meaning set forth in Section 2(a)(ii).

  • Minimum Qualifications Qualifications mandated for the position and which must be possessed by an employee before the employee can be considered for employment in a specific classification.

  • Qualifications , in relation to an employee, means any degree, diploma or other academic, technical or professional qualification relevant to the position which he held.

  • Qualification means any degree, diploma or certificate conferred upon a person after having been examined in respect of that person’s proficiency in a particular field of study;

  • pre-qualification means the first stage of the Bidding Process involving the submission, opening and evaluation of the Qualification Documents submitted by the Prospective Bidders.

  • Request For Qualifications (RFQ means the written solicitation, including all Addenda thereto, issued by the Department seeking SOQs in order to identify and Short-List the Proposers to receive the RFP for the Project.

  • Request for Qualifications means all materials and

  • Evaluation rubric means a set of criteria, measures, and processes used to evaluate all teaching staff members in a specific school district or local education agency. Evaluation rubrics consist of measures of professional practice, based on educator practice instruments and student outcomes. Each Board of Education will have an evaluation rubric specifically for teachers, another specifically for Principals, Vice Principals, and Assistant Principals, and evaluation rubrics for other categories of teaching staff members.

  • Auction Rules means the West Bengal Minor Mineral (Auction) Rules, 2016.

  • Eligibility Requirement means all eligibility requirements and other qualification requirements for a person to act in the applicable Corporate Trust Capacity under any Appointment as set forth in the related Corporate Trust Contract, including any required authorizations or licenses from the Federal National Mortgage Association, the Federal Home Loan Mortgage Corporation, the Government National Mortgage Association, the Federal Housing Administration, the Federal Home Loan Bank or the Department of Veterans Affairs.

  • Statement of Qualifications means a written statement submitted to a procurement unit in response to a request for statement of qualifications.

  • Eligibility Requirements means, with respect to any Person, that such Person (i) has total assets (in name or under management) in excess of $600,000,000 and (except with respect to a pension advisory firm or similar fiduciary) capital/statutory surplus or shareholder’s equity of $250,000,000 and (ii) is regularly engaged in the business of making or owning commercial real estate loans or operating commercial mortgage properties.

  • Common Rules means the rules and regulations specified in Schedule [G] to be observed by the Apartment Acquirers for the common, peaceful, effective and harmonious use and enjoyment of the Project;

  • Nondisqualification Opinion An Opinion of Counsel, prepared at the Trust’s expense and payable from the Collection Account, that a contemplated action will not cause (i) either the Lower-Tier REMIC or the Upper-Tier REMIC to fail to qualify as a REMIC or (ii) a “prohibited transaction” or “prohibited contributions” tax to be imposed on either the Lower-Tier REMIC or the Upper-Tier REMIC at any time that any Certificates are outstanding.

  • Qualified means that a person holds a certificate, permit or other document equivalent to that which staff in a public school are required to hold to provide special education and designated instruction and services and has met federal and state certification, licensing, registration, or other comparable requirements which apply to the area in which he or she is providing special education or related services, including those requirements set forth in Title 34 of the Code of Federal Regulations sections 200.56 and 200.58, and those requirements set forth in Title 5 of the California Code of Regulations Sections 3064 and 3065, and adheres to the standards of professional practice established in federal and state law or regulation, including the standards contained in the California Business and Professions Code. Nothing in this definition shall be construed as restricting the activities in services of a graduate needing direct hours leading to licensure, or of a student teacher or intern leading to a graduate degree at an accredited or approved college or university, as authorized by state laws or regulations. (Title 5 of the California Code of Regulations Section 3001 (r)).

  • Breach Notification Rule means the HIPAA Regulation that is codified at 45 C.F.R. Parts 160 and 164, Subparts A and D.

  • Qualify or "qualified" means to take the oath of office and begin performing the

  • Common Rule means the "Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments; Final Rule" originally issued at 53 FR 8034-8103 (March 11, 1988). Other common rules will be referred to by their specific titles.

  • Mediation Rules As defined in Section 2.03(h)(i).

  • Impermissible Qualification means, relative to the opinion or certification of any independent public accountant as to any financial statement of the Borrower, any qualification or exception to such opinion or certification:

  • Level V Status exists at any date if, on such date, the Borrower has not qualified for Level I Status, Level II Status, Level III Status or Level IV Status.