Regulatory inspection definition

Regulatory inspection means an inspection required in accordance with section 22a- 409(c) of the Connecticut General Statutes and section 22a-409-2(c) of the Regulations of Connecticut State Agencies.
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Regulatory inspection means an activity undertaken by the regulatory body to determine by investigation, examination and evaluation of objective evidence the adequacy of, and adherence to, the Act, regulations, standards, administrative or operational programs and other applicable documents, and the effectiveness of their implementation;
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Regulatory inspection has the meaning set out in Clause 8.6;
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Examples of Regulatory inspection in a sentence

  • The investigator must allow the auditors to review original source records and study documentation for all participants.− Regulatory inspection: Regulatory authorities may conduct an inspection of the study and the site at any time during the development of an investigational product.

  • Regulatory inspection and review and assessment activity ensure that compliance with the requirements is maintained throughout the activity.

  • Regulatory inspection officers checking drug storage facilities will confirm that cabinets/safes are secured properly.

  • In the event of a Regulatory inspection which directly involves Drug Product, Dyax shall be promptly, but no later than [*****] after initiation of inspections, informed of the inspection.

  • Regulatory inspection is carried out for Category 1 sources and radiopharmaceuticals.

  • PathoGenesis may send its representatives to participate in any Regulatory inspection, audit or other inquiry with respect to Processing under this Agreement, as deemed appropriate by PathoGenesis.

  • Regulatory inspection .......................................................................................................

  • Statutory inspection (1) Regulatory inspection of CS is provided by the Office of Standards in Education (Ofsted) and regular, unannounced, examinations of policy and practise are undertaken.

  • The assessment of the utility is carried out either during Regulatory inspection or team visit constituted for this purpose.

  • Regulatory inspection of beach sand mineral facilities was carried out during this period and the periodic radiological reports submitted by the facilities were reviewed.


More Definitions of Regulatory inspection

Regulatory inspection means an inspection by the Competent Authority to determine compliance by ViruSure with GMP in performance of the Services.
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Regulatory inspection means audit or due diligence of USoA in the licensed company.
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Regulatory inspection means an inspection that is requested to satisfy the requirements of laws that are other than the construction code and that relate to health, safety, or public welfare.
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Regulatory inspection means an inspection of the Supplier's premises, processes and/or equipment used in the production, storage or packaging of the Serum Products or in keeping or otherwise using or in relation to keeping or otherwise using such sheep as are used therein, by any appropriate regulatory authority including, but not limited to, the United States Food and Drug Administration ("FDA") or by any officer in the performance of their duties pursuant to any legislation to which the Supplier is required to comply, in whole or in part, hereby, including without limitation, the Prevention of Cruelty to Animals Act 1985 (South Australia) and the Animal Welfare Act 1993 (Xxxxxxxx);
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Related to Regulatory inspection

  • Regulatory Information Service means a regulatory information service as defined in the Takeover Rules.

  • Lead inspection means a surface-by-surface investigation to determine the presence of lead-based

  • External inspection means an inspection made when a boiler is in operation.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Adverse Event means any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

  • Explanatory Indicator means a measure that is connected to and helps to explain performance in a Performance Indicator or a Monitoring Indicator. An Explanatory Indicator may or may not be a measure of the HSP’s performance. No Performance Target is set for an Explanatory Indicator;

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Home inspection means the on-site, physical review of the home of an applicant to assure the applicant and the home meets all health and safety requirements within these rules.

  • Final Inspection means the process and procedure described in UGC Section 12.

  • Facilities Study shall be an engineering study conducted by the Transmission Provider (in coordination with the affected Transmission Owner(s)) to: (1) determine the required modifications to the Transmission Provider’s Transmission System necessary to implement the conclusions of the System Impact Study; and (2) complete any additional studies or analyses documented in the System Impact Study or required by PJM Manuals, and determine the required modifications to the Transmission Provider’s Transmission System based on the conclusions of such additional studies. The Facilities Study shall include the cost and scheduled completion date for such modifications, that will be required to provide the requested transmission service or to accommodate a New Service Request. As used in the Interconnection Service Agreement or Construction Service Agreement, Facilities Study shall mean that certain Facilities Study conducted by Transmission Provider (or at its direction) to determine the design and specification of the Customer Funded Upgrades necessary to accommodate the New Service Customer’s New Service Request in accordance with Tariff, Part VI, section 207.

  • Studies means activities needed to prepare project implementation, such as preparatory, mapping, feasibility, evaluation, testing and validation studies, including in the form of software, and any other technical support measure, including prior action to define and develop a project and decide on its financing, such as reconnaissance of the sites concerned and preparation of the financial package;

  • Initial inspection means the first on-site inspection of facilities to verify declarations submitted pursuant to Articles III, IV, V and VI and this Annex.

  • Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.

  • Inspections has the meaning set forth in Section 4.1.2.

  • Authority’s Engineer shall have the meaning set forth in Clause 18.1;

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Regulatory Services Provider means the organization which provides regulatory services to BSEF pursuant to a Regulatory Services Agreement.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Product Complaint means any oral, electronic or written communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a marketed product, including failure of the product, labelling or packaging to meet specifications, whether or not the product is related to or caused the alleged deficiency. A complaint may allege that an Adverse Event or Medical Device Malfunction (as defined herein) has occurred.

  • Geotechnical engineer means a Professional Engineer whose principal field of specialization is the design and Construction of earthworks in a permafrost environment.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Study Data shall have the meaning set forth in Section 8.1.

  • Protocol means, in respect of any category of object and associated rights to which this Convention applies, the Protocol in respect of that category of object and associated rights;

  • Inspecting Authority means the authorised representative of the Department to act as Inspecting Authority for the purpose of this contract and for the purpose of ascertaining the progress of the deliveries under the contract.

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, Marketing Authorizations or other written materials, correspondence, submissions made to or with a Regulatory Authority that are necessary or reasonably desirable in order to Develop, Manufacture or Commercialize the Licensed Products in the Field in a particular country.

  • Regulatory Data means any and all research data, pharmacology data, chemistry, manufacturing, and control data, preclinical data, clinical data or all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product in the Field (including any Drug Master Files (DMFs), Chemistry, Manufacturing and Control (“CMC”) data, or similar documentation).