CONTROL AND QUALITY ASSURANCE. The CONSULTANT shall provide a description of its Quality Control procedure. The process shall be implemented for all facets of Work and a QC-QA statement and signature shall be placed on all submittals to the DISTRICT.
CONTROL AND QUALITY ASSURANCE. To ensure that we produce a well-engineered PS&E package with a minimal number of construction contract change orders, KOA implements a robust QA/QC process that is followed from the beginning to the end of the project. The QA/ QC plan includes a number of steps, including: (1) Holding design meetings with the City’s PM, senior civil engineers and public services/transportation management staff at key phases in the project design/approval; (2) Obtaining comments and input from the City; and (3) Conducting internal plancheck and QA/QC with KOA’s engineering and construction management staff. This includes tracked color-coded review comments coordinated in Revu Bluebeam® sessions, completion of review checklists, and independent peer review from senior staff to ensure the feasibility and constructability of the project design. KOA’s constructability reviews also allow us to: (1) amplify the odds of being able to identify and anticipate any potential construction problems or conflicts; (2) develop better design alternatives early on in the design phase, and continually throughout the PS&E delivery stages; and (3) provide the City with adequate estimates, quantity takeoffs, and pavement cross sections if needed beyond the typical pavement structural sections provided to us by the City. ENGINEERING DESIGN SERVICES FOR XXXXX AVENUE AND PINECREEK DRIVE INTERSECTION PROJECT (“PROJECT A”) AND XXXXX AVENUE BICYCLE FACILITY PROJECT (“PROJECT B”) Below is KOA’s proposed schedule for the projects, to be performed in tandem. 1 day 4 wks Kickoff Meeting Milestone Summary Task Date: Wed 12/9/20 2 wks Final Submittal - 100% PS&E Package 2 wks 90% City Review 5 wks 90% PS&E 15 2 wks 65% City Review 8 wks 65% PS&E 13 0 wks 14 wks Environmental Clearance ‐ Project B 14 wks Environmental Clearance ‐ Project A 0 wks 2 wks City Review - Concept Design 4 wks Concept Design
CONTROL AND QUALITY ASSURANCE. To ensure compliance with Good Clinical Practice and all applicable regulatory requirements, Hepion (or representative) may conduct a quality assurance audit. Please see Section 13.2 for more details regarding the audit process.
CONTROL AND QUALITY ASSURANCE. During trial conduct, VIVUS or its agent will conduct periodic monitoring visits to ensure that the protocol and GCPs are being followed. The monitors may review source documents to confirm that the data recorded on CRFs are accurate. The investigator and institution will allow VIVUS monitors or its agents and appropriate regulatory authorities direct access to all appropriate source documents to perform this verification. The trial site and trial-related documents may be subject to review by the institutional review board (IRB)/independent ethics committee (IEC), and/or to quality assurance audits performed by VIVUS or its agents, and/or to inspection by appropriate regulatory authorities. It is important that the investigator(s) and their relevant personnel are available during the monitoring visits and possible audits or inspections and that sufficient time is devoted to the process by the investigator and site personnel.
CONTROL AND QUALITY ASSURANCE. During trial conduct, VIVUS, Inc. or its agent will conduct periodic monitoring visits to ensure that the protocol and GCPs are being followed. The monitors may review source documents to confirm that the data recorded on CRFs are accurate. The investigator and institution will allow VIVUS, Inc. monitors or its agents and appropriate regulatory authorities direct access to all appropriate source documents to perform this verification. The trial site and trial-related documents may be subject to review by the institutional review board (IRB)/independent ethics committee (IEC), and/or to quality assurance audits performed by VIVUS, Inc. or its agents and/or to inspection appropriate regulatory authorities. Refer to Section 13. It is important that the investigator(s) and their relevant personnel are available during the monitoring visits and possible audits or inspections and that sufficient time is devoted to the process by the investigator and site personnel.
CONTROL AND QUALITY ASSURANCE. COPHARMA shall conduct quality control testing and release the PRODUCT (hereafter referred to as "COPHARMA QA release") in accordance with (a) the methods and procedures described in the Manufacturing and Release Requirements, and (b) current Regulatory Requirements. Unless otherwise authorized by SERAGEN, shipment of PRODUCT shall not occur prior to SERAGEN's release of the PRODUCT, which release will be based solely upon SERAGEN'S review of the MRR Documentation supplied by COPHARMA. COPHARMA shall retain all records pertaining to testing as required by cGMP.
CONTROL AND QUALITY ASSURANCE. To ensure compliance with Good Clinical Practice and all applicable regulatory requirements, Sage Therapeutics may conduct a quality assurance audit(s) at the clinical site. Please see Section 14.2 for more details regarding the audit process. The investigator must have adequate quality control practices to ensure that the study is performed in a manner consistent with the protocol, GCP/ICH GCP guidelines, and applicable regulatory requirements. The investigator is responsible for reviewing all identified protocol deviations. Significant protocol deviations should be reported to the IRB/IEC per the IRB/IEC’s written procedures. The investigator is responsible for supervising any individual or party to whom the investigator delegates trial-related duties and functions conducted at the trial site. When the investigator retains the services of any individual or party to perform trial-related duties and functions, the investigator must ensure the individual or party is qualified to perform trial-related duties and functions and should implement procedures to ensure the integrity of the trial-related duties and functions performed, and any data generated. The investigator must maintain adequate and accurate source documents and trial records that include all pertinent observations on each of the site’s trial participants. Source data must be attributable, legible, contemporaneous, original, accurate, and complete. Changes to source data should be traceable, should not obscure the original entry, and should be explained, if necessary to provide clarification.
CONTROL AND QUALITY ASSURANCE. The ENGINEER shall provide a description of its Quality Control procedure. The process shall be implemented for all facets of Work and a QC-QA statement and signature shall be placed on all submittals to the DISTRICT.
CONTROL AND QUALITY ASSURANCE. The Investigator and institution will permit study-related monitoring, audits, IRB review, and regulatory inspections as requested by the Food and Drug Administration, Sage, or Xxxx’s designee, including direct access to source data/documents (ie, original medical records, laboratory reports, hospital documents, progress reports, signed ICFs) in addition to eCRFs. Quality assurance and quality-control systems with written standard operating procedures will be followed to ensure this study will be conducted and data will be generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirements. The site’s dedicated study monitor will arrange to visit the Investigator at regular intervals during the study. The monitoring visits must be conducted according to the applicable ICH and GCP guidelines to ensure protocol adherence, quality of data, drug accountability, compliance with regulatory requirements, and continued adequacy of the investigational site and its facilities. During these visits, eCRFs and other data related to the study will be reviewed and any discrepancies or omissions will be identified and resolved. The study monitor will be given access to study-relevant source documents (including medical records) for purposes of source data verification. During and/or after completion of the study, quality-assurance officers named by Sage Therapeutics or the regulatory authorities may wish to perform on-site audits. The Investigator is expected to cooperate with any audit and provide assistance and documentation (including source data) as requested. Quality control will be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly. Agreements made by Xxxx with the Investigator/institution and any other parties involved with the clinical study will be in writing in a separate agreement.
CONTROL AND QUALITY ASSURANCE. 5.1 Each lot of Finished Products manufactured by Noven in accordance with Article 2 herein shall meet the applicable release standards as set forth in the Specifications to assure the Finished Products meet regulatory specifications at all times through the expiration date of that lot as defined in the applicable Product Application. Noven shall employ appropriate change control procedures to ensure that the applicable release standards remain congruent with the applicable Product Application. Control procedures and analytical test methods referenced in a given Product Application may not be modified or superseded without the express written or verbal consent of Novartis and only, if necessary, after approval by the appropriate GRB.
5.2 Noven shall be responsible for procuring all Materials and shall ensure, through applicable GMP testing, that at all times all Materials used in the manufacture of the Finished Products are in compliance with their specifications and, as appropriate, are within the expiration dates printed on their labels or packaging. Noven shall ensure that all Materials are stored according to the precise storage conditions provided by their manufacturer or supplier. Noven shall carry out all Materials testing in accordance with GMP and all laboratory testing failures shall be promptly investigated and documented in reasonable detail. Noven may release Materials for processing only upon receipt of satisfactory test results. Noven shall employ appropriate change control procedures to ensure the control procedures remain congruent with the applicable Product Application and shall notify Novartis promptly of any changes to control procedures.
5.3 Noven shall ensure that all Materials released for processing are tested in accordance with agreed specifications and the filed Product Application. Noven will confirm that all batches of Materials correspond to the applicable specifications and GMP and are approved by Noven for incorporation into the Finished Product. Noven shall retain samples of all Materials used to prepare a lot of a Finished Product (except for water and volatile solvents) for a period of at least one year beyond the expiration date of the last lot of Finished Product containing said component. Packaging components are represented by Noven's retention of samples of finished dosage forms. The amount of retained sample shall be sufficient for at least three complete and full testing analyses in accordance with the control proc...
