Methods Validation Certification Sample Clauses

Methods Validation Certification. Fresenius is responsible for providing to TransMedics a Certification of Methods Validation Compliance for all critical methods practiced by Fresenius (raw materials testing, in- process product testing, product batch release, component and product stability and cleaning validation). The certifications should state, ’’The methods are appropriate for the intended purpose, are validated per relevant regulatory guidelines and are readily available in case of a regulatory inspection.’’
Sample 1Sample 2Sample 3
AutoNDA by SimpleDocs
Methods Validation Certification. 5.9.1 For those analytical methods to be provided by Barrier, Barrier shall be responsible for providing to DSM approved copies of the current and complete regulatory filed analytical methods relating to the Products, for application by DSM in the production process, including receipt of API and raw materials, in-process product testing, product lot release, drug and product stability, and cleaning validation. 5.9.2 For the analytical methods to be provided by Barrier as forth in Section 5.9.1, Barrier shall provide to DSM a Certification of Methods Validation Compliance stating that “The methods are appropriate for the intended purpose, are validated per relevant regulatory guidelines, and are readily available in case of a regulatory inspection.” 5.9.3 Any new analytical methods that are to be validated by DSM must be reviewed and approved by Barrier prior to implementation.
Sample 1Sample 2
Methods Validation Certification. (a) For any analytical methods, Nastech shall be responsible for providing to LICENSEE approved copies of the current and complete regulatory filed analytical methods relating to the Product for application in the production process, including raw materials, in-process product testing, product lot release, drug and product stability, and cleaning validation. (b) For any analytical methods, Nastech shall provide to LICENSEE a Certification of Methods Validation Compliance stating that "The methods are appropriate for the intended purpose, are validated per relevant regulatory guidelines, and are readily available in case of a regulatory inspection."
Sample 1
Methods Validation Certification. SkyePharma is responsible for providing to Enzon a Certification of Methods Validation Compliance for all critical methods practiced by SkyePharma (raw materials testing, in-process product testing, product batch release, drug and product stability and cleaning validation). The certifications should state, “The methods are appropriate for the intended purpose, are validated per relevant regulatory guidelines and are readily available in case of a regulatory inspection.”
Sample 1
Methods Validation Certification. 5.7.1. ORPHAN is responsible for providing to CELLTECH approved copies of the most current and complete filed analytical methods relating to the Product for receipt of Materials, in-process product testing, Product lot release, Product stability and cleaning validation. 5.7.2. ORPHAN is responsible for providing to CELLTECH a Certification of Methods Validation for all critical methods practiced by ORPHAN or its contractors (Materials testing, in-process Product testing, Product lot release, Product stability and cleaning validation). The certifications should state "THE METHODS ARE APPROPRIATE FOR THE INTENDED PURPOSE, ARE VALIDATED PER RELEVANT REGULATORY GUIDELINES AND ARE READILY AVAILABLE IN CASE OF A REGULATORY INSPECTION."
Sample 1

Related to Methods Validation Certification

  • TERMINATION CERTIFICATION Upon separation from employment with the Company, I agree to immediately sign and deliver to the Company the “Termination Certification” attached hereto as Exhibit C. I also agree to keep the Company advised of my home and business address for a period of three (3) years after termination of my employment with the Company, so that the Company can contact me regarding my continuing obligations provided by this Agreement.

  • COMPENSATION CERTIFICATION Labor Code Section 3700 in relevant part provides: Every employer except the State shall secure the payment of compensation in one or more of the following ways:  By being insured against liability to pay compensation by one or more insurers duly authorized to write compensation insurance in this State.  By securing from the Director of Industrial Relations a certificate of consent to self-insure, which may be given upon furnishing satisfactory proof to the Director of Industrial Relations of ability to self-insure and to pay any compensation that may become due to its employees. I am aware of the provisions of Section 3700 of the Labor Code which require every employer to be insured against liability for workers’ compensation or to undertake self-insurance in accordance with the provisions of that code, and I will comply with such provisions before commencing the performance of the Work of this Contract. Date: Name of Consultant: Signature: Print Name and Title: (In accordance with Article 5 – commencing at Section 1860, Chapter 1, part 7, Division 2 of the Labor Code, the above certificate must be signed and filed with the District prior to performing any Work under this Contract.) Consultant’s entire Proposal is not made part of this Agreement.

  • AS9100 Certification ‌ AS9100 Certification, specifies requirements for a quality management system to demonstrate the Contractor’s ability to consistently meet the customer requirements as well as statutory and regulatory requirements for the aerospace industry. An AS9100 Certification, is not mandatory; however, Contractors who desire to compete for work within the aerospace industry are encouraged to have AS9100 Certification, during the entire term of OASIS. The Contractor shall notify the OASIS CO, in writing, if there are any changes in the status of their AS9100 Certification, and provide the reasons for the change and copies of audits from an AS9100 Certification Body, as applicable. If only part of a Contractor’s organization is AS9100, certified, the Contractor shall make the distinction between which business units or sites and geographic locations have been certified.

  • COMPLIANCE AND CERTIFICATION 25.1 Each Party shall comply at its own expense with all Applicable Laws that relate to that Party’s obligations to the other Party under this Agreement. Nothing in this Agreement shall be construed as requiring or permitting either Party to contravene any mandatory requirement of Applicable Law. 25.2 Each Party warrants that it has obtained all necessary state certification required in each state covered by this Agreement prior to ordering any Interconnection, Resale Services, Network Elements, functions, facilities, products and services from the other Party pursuant to this Agreement. Upon request, each Party shall provide proof of certification. 25.3 Each Party shall be responsible for obtaining and keeping in effect all approvals from, and rights granted by, Governmental Authorities, building and property owners, other carriers, and any other Third Parties that may be required in connection with the performance of its obligations under this Agreement. 25.4 Each Party represents and warrants that any equipment, facilities or services provided to the other Party under this Agreement comply with the CALEA.

  • Exhibit D - Debarment Certification By signing and submitting this Contract, the Contractor is agreeing to abide by the debarment requirements as set out below.

  • DEBARMENT AND SUSPENSION CERTIFICATION CONTRACTOR certifies that it and its principals:

  • CHILD SUPPORT CERTIFICATION Under Section 231.006, Texas Family Code, the Engineer certifies that the individual or business entity named in this contract, bid, or application is not ineligible to receive the specified grant, loan, or payment and acknowledges that this contract may be terminated and payment may be withheld if this certification is inaccurate. If the above certification is shown to be false, the Engineer is liable to the state for attorney’s fees, the cost necessary to complete the contract, including the cost of advertising and awarding a second contract, and any other damages provided by law or the contract. A child support obligor or business entity ineligible to receive payments because of a payment delinquency of more than thirty (30) days remains ineligible until: all arrearages have been paid; the obligor is in compliance with a written repayment agreement or court order as to any existing delinquency; or the court of continuing jurisdiction over the child support order has granted the obligor an exemption from Subsection (a) of Section 231.006, Texas Family Code, as part of a court- supervised effort to improve earnings and child support payments.

  • Financial Information Certifications The Parties agree to cooperate with each other in such manner as is necessary to enable the principal executive officer or officers, principal financial officer or officers and controller or controllers of each of the Parties to make the certifications required of them under Sections 302, 404 and 906 of the Xxxxxxxx-Xxxxx Act of 2002.

  • OFAC Certification Company certifies that (i) it is not acting on behalf of any person, group, entity, or nation named by any Executive Order or the United States Treasury Department, through its Office of Foreign Assets Control (“OFAC”) or otherwise, as a terrorist, “Specially Designated Nation”, “Blocked Person”, or other banned or blocked person, entity, nation, or transaction pursuant to any law, order, rule or regulation that is enforced or administered by OFAC or another department of the United States government, and (ii) Company is not engaged in this transaction on behalf of, or instigating or facilitating this transaction on behalf of, any such person, group, entity or nation.

  • Licenses and Certifications Where required by law, PROVIDER must, at all times, be licensed or certified by either the State or County as a qualified provider of the services purchased hereby. PROVIDER shall fully cooperate with licensing and certification authorities. PROVIDER shall submit copies of the required licenses or certifications upon request by COUNTY. PROVIDER shall promptly notify COUNTY in writing of any citation PROVIDER receives from any licensing or certification authority, including all responses and correction plans.

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