Analytical Method Validation Sample Clauses

Analytical Method Validation. Cangene must ensure that its analytical methods (including packaging procedures) are validated. If the methods are not validated by Cangene, then Patheon may assist in validation development with the costs being borne by Cangene.
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Analytical Method Validation. The analytical methods for the three strengths dosages developed by Corealis will be validated in its GMP laboratory. The method will be validated according to ICH guidelines. The method for cleaning verification will also require complete validation. Cost: $75,100* * Includes analytical method validation of assay and content uniformity, related substances, and dissolution for the three strengths as well as for cleaning. If required and pre-approved in writing by the Client, the analytical method validation for the microbial limit will be done at an additional cost of [****].
Analytical Method Validation. Synageva must ensure that its analytical methods are validated. If the methods are not validated by Synageva, then Patheon may assist in validation development with the costs being borne by Synageva subject to Synageva’s prior written approval. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Analytical Method Validation. Analytical method validation and transfer will be performed by Manufacturer and completed by [*].

Related to Analytical Method Validation

  • Validation To validate the notice requirements outlined in Section 5.3, the Assuming Institution shall provide the Receiver (i) an Affidavit of Publication to meet the publication requirements outlined in Section 5.3(a) and (ii) the Assuming Institution will prepare an Affidavit of Mailing in a form substantially similar to Exhibit 2.3B after mailing the seven (7) day Notice to Depositors as required under Section 5.3(b).

  • Laboratory Testing All laboratories selected by UPS Freight for analyzing Controlled Substances Testing will be HHS certified.

  • Validation Mechanism To be eligible for articulation, the student must show evidence of their CompTIA A+ certification and it must have been issued within three (3) years prior to their enrollment in the program.

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • Drug Testing (A) The state and the PBA agree to drug testing of employees in accordance with section 112.0455, F.S., the Drug-Free Workplace Act. (B) All classes covered by this Agreement are designated special risk classes for drug testing purposes. Special risk means employees who are required as a condition of employment to be certified under Chapter 633 or Chapter 943, F.S. (C) An employee shall have the right to grieve any disciplinary action taken under section 112.0455, the Drug-Free Workplace Act, subject to the limitations on the grievability of disciplinary actions in Article 10. If an employee is not disciplined but is denied a demotion, reassignment, or promotion as a result of a positive confirmed drug test, the employee shall have the right to grieve such action in accordance with Article 6.

  • Human Leukocyte Antigen Testing This plan covers human leukocyte antigen testing for A, B, and DR antigens once per member per lifetime to establish a member’s bone marrow transplantation donor suitability in accordance with R.I. General Law §27-20-36. The testing must be performed in a facility that is: • accredited by the American Association of Blood Banks or its successors; and • licensed under the Clinical Laboratory Improvement Act as it may be amended from time to time. At the time of testing, the person being tested must complete and sign an informed consent form that also authorizes the results of the test to be used for participation in the National Marrow Donor program.

  • Product Testing No later than [**] prior to a scheduled Delivery ARIAD US shall send to ARIAD SWISSCO the Delivery Documents for review. Following such review, unless within [**] of receipt of the Delivery Documents ARIAD SWISSCO gives written notice of rejection of the Product to be delivered, stating the reasons for such rejection, the Delivery shall proceed, and both Parties shall organize the same. Upon arrival at ARIAD SWISSCO nominated site it shall visually inspect the shipment of the Product to identify any damage to the external packaging. ARIAD SWISSCO may reject any shipment (or portion thereof) of the Product that is damaged by providing to ARIAD US reasonable evidence of damage within [**] after Delivery of such Product. If ARIAD SWISSCO does not so reject any shipment (or portion thereof) of the Product within [**] of Delivery of such Product, ARIAD SWISSCO shall be deemed to have accepted such shipment of the Product; provided, however, that in the case of the Product having any Latent Defect, ARIAD SWISSCO shall notify ARIAD US promptly once it becomes aware that a Product contains a Latent Defect and subsequently may reject such Product by giving written notice to ARIAD US of ARIAD SWISSCO’s rejection of such Product and shipping a representative sample of such Product or other evidence of Non-Conformance to ARIAD US within [**] after becoming aware of such Latent Defect, which notice shall include a description of the Latent Defect.

  • Separation of Components The SOFTWARE PRODUCT is licensed as a single product. Its component parts may not be separated for use on more than one computer.

  • Random Testing Notwithstanding any provisions of the Collective Agreement or any special agreements appended thereto, section 4.6 of the Canadian Model will not be applied by agreement. If applied to a worker dispatched by the Union, it will be applied or deemed to be applied unilaterally by the Employer. The Union retains the right to grieve the legality of any imposition of random testing in accordance with the Grievance Procedure set out in this Collective Agreement.

  • Contractor Selection In this section, please describe the selection process, including other sources considered and the rationale for selecting the contractor. Please answer all questions: a. What specific skill set does this contractor bring to the project? Please attach a copy of the contractor’s resume if an individual or link to contractor website if a company: Little to Great Scientists is an international leader in early childhood, elementary, middle and high school science education. xxxxx://xxxxxxxxxxxxxxxxxxxxxxx.xxx/ b. How was the Contractor selected? Quotes, RFP/RFQ, Sealed Bid or Sole Source designation from the City of New Haven Purchasing Department? This contractor was selected because of their continued commitment to NHPS. They possess the knowledge base, resources, and motivation to support hands-on science education in New Haven. No other contractors were considered for this partnership. c. Is the contractor the lowest bidder? N/A If no, why? Why was this contractor selected? This contractor was selected because of their unique expertise in hands-on science learning and their continued commitment to New Haven Public Schools. They possess the knowledge and resources to support science learning at Xxxxxxx Xxxxxx School. d. Who were the members of the selection committee that scored bid applications? N/A e. If the contractor is Sole Source, please attach a copy of the Sole Source designation letter from the City of New Haven Purchasing Department. N/A

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