Maintaining control: Remote working and QP certification
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...at the site and an active role in quality management. Inspectors will look for evidence of how often the QP is on site, and their active participation in monitoring the...
...at the site and an active role in quality management. Inspectors will look for evidence of how often the QP is on site, and their active participation in monitoring the...
...also identified in earlier in the quality control section with new text referring to centralised or on-site quality control of such sites. The current section on Monitor’s Responsibilities has been...
...so;” The MHRA re-affirm that a licenced site can only be interpreted as being under full GDP control at a licenced WDA site. This applies to all categories of medicines....
...in place soon thereafter will be accepted. The site will need to demonstrate they have identified the high risk sites and have an action plan to ensure the studies are...
...into. When the database changed to allow site access, the paper CRFs at site became the equivalent of source worksheets, with data being transcribed directly into the sponsor’s database. The...
...early or is postponed at the last minute (for example if a site is found not to ready to be inspected or an incident at the site means we can...
Lab assistants doing research. People in white coats using microscope, test tubes flat vector illustration. Laboratory, chemistry, medical test concept for banner, website design or landing web page. Image: (https://www.freepik.com/vectors/lab-technician)...
...within the Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the MHRA - GOV.UK (www.gov.uk) and the MHRA website stated changes...
...required for these. The shorter form which you may use is the Health Research Authority Annual Progress Report form which can be found here: https://www.hra.nhs.uk/documents/1013/annual-report-form-for-ctimps.docx When submitting your annual report,...
...inspection team thinks there is a possibility of escalation they will stop the inspection and let the site know. This pause gives the site the chance to inform the right...