Health Canada Validation Requirements

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Guidance document : preparation of regulatory activities in the

(1 days ago) WEBGuidance document : preparation of regulatory activities in the Electronic Common Technical Document (eCTD) format.: H164-293/2019E-PDF "This guidance document …

https://publications.gc.ca/site/eng/9.882674/publication.html

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Guide to validation : drugs and supporting activities.

(1 days ago) WEBIssued also in French under title: Guide sur la validation : médicaments et activités de soutien. Issued also in HTML format. "GUI-0029." "June 29, 2021." Includes …

https://publications.gc.ca/site/eng/9.882946/publication.html

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Cleaning validation guide

(7 days ago) WEBThese guidelines interpret the requirements for good manufacturing practices (GMP) in Part C, Division 2 of the Regulations. They were developed by Health Canada in …

https://assets.ctfassets.net/a44nqpvb9zjg/78mndAlqro9UU1jGjZFZ9f/590f73df600ae18473ae2d7f23805f85/Health_Canada_GUI-0028_EN.pdf

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Health Canada New Validation Rules Version 5 0 - Pharma Focus …

(9 days ago) WEBHealth Canada keeps amending these validation rules to assist the sponsors for the successful dispatch of the submissions. The Agency will be using the recently updated …

https://www.pharmafocusasia.com/strategy/health-canada-new-validation

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SCC Requirements and Guidance for Method Verification and …

(Just Now) WEBSCC Requirements and Guidance for Method Verification and Validation in Testing Laboratories (RG-MVVT) 2021-05-24. Standards Council of Canada 55 Metcalfe Street, …

https://www.scc.ca/en/system/files/publications/ASB_RG_Method-Validation_v2_2021-05-24.pdf

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Regulatory submissions and transactions with Health Canada

(8 days ago) WEBStarting January 1, 2020, all regulatory transactions for Master Files prepared in the non-eCTD format must be sent via the Common Electronic Submission …

https://www.certara.com/blog/regulatory-submissions-and-transactions-with-health-canada/

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Validation of Computerized Systems – Guidance Document

(5 days ago) WEBresearch information should be adequately validated, and evidence of validation should be readily available to Health Canada`s Inspectors. (Health Canada – Annex 11) …

https://www.acrc.albertainnovates.ca/public/download/files/190547

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Health Canada, FDA Process Validation Guidance - AXSource

(1 days ago) WEBOverall outline of AXSource’s Validation Master Plan (VMP), states how the validation will be conducted, including: AXSource Consulting uses a lifecycle approach to …

https://regulatory.axsource.com/process-validation/

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Cleaning Validation Resources

(1 days ago) WEBResources. Link of interest in cleaning validation. Canadian Cleaning Validation Guidelines from Health Canada (also available in French). FDA’s cleaning validation …

https://cleaningvalidation.com/resources/

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Control measures for Listeria monocytogenes in ready-to-eat foods

(3 days ago) WEBThis document has been revised to align with Health Canada's Policy on Listeria monocytogenes in ready-to eat foods (2023) that will come into effect on October 1st …

https://inspection.canada.ca/preventive-controls/listeria-monocytogenes/eng/1518103693274/1528201904208

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REDCap Support - Signatures in Health Canada Clinical Trials

(8 days ago) WEBDuring recent inspections of clinical trials at the University of Alberta, it has become apparent that the following forms of electronic signature are not acceptable to Health …

https://help.redcap.ualberta.ca/policy-procedure/clinical-trials/signatures-in-health-canada-clinical-trials

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Does Computer System Validation Apply To You? - AXSource

(4 days ago) WEBComputer System Validation has been a regulatory (e.g. FDA, Health Canada) requirement for more than two decades. Nevertheless, companies have problems with …

https://regulatory.axsource.com/erp-system-validation/

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Pharma Serialization requirements for Canada - Cosmotrace

(6 days ago) WEBKey dates in Canada: For Manufacturers – 31 st Dec 2021 – 31 st Dec 2023 – Serialization implementation timeline, it is not mandatory but encouraged to do so by …

https://blog.cosmotrace.com/serialization/pharma-serialization-requirements-for-canada

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Pre-boarding Identification Requirements - Travel.gc.ca

(2 days ago) WEBbirth certificate. driver's licence. health card. identification card. Other valid documents. Canadian military identification. Certificate of Indian Status (status card) Federal police …

https://travel.gc.ca/air/identification-requirements

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Validation - Q&R Canada

(3 days ago) WEBValidation documentation requirements exist for fabricators, packagers, labelers, testers, importers and distributors of regulated products. Inspectors will evaluate at the …

https://www.qandrcanada.com/drug-products/validation/

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Cardinal Health hiring Validation Engineer in Gananoque, Ontario

(3 days ago) WEBCardinal Health Canada is currently seeking a Validation Engineer to join the Engineering department on a full time, permanent basis in our Medical Device Manufacturing Facility …

https://ca.linkedin.com/jobs/view/validation-engineer-at-cardinal-health-3755174834

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In effort to prevent rabies, CDC launches new rules for bringing …

(9 days ago) WEBThe United States has new rules for how dogs are brought into the country, and they go into effect in August. The US Centers for Disease Control and Prevention …

https://www.cnn.com/2024/05/08/health/cdc-dog-import-rules/index.html

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From August 1, 2024, Onward: What Your Dog Needs to Enter the …

(Just Now) WEBRequirements for dogs with a current and valid rabies vaccination administered in the United States. Specific requirements depend on whether the dog …

https://www.cdc.gov/importation/bringing-an-animal-into-the-united-states/dogs-entering-us-after-august-1.html

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Helping Canadians breathe easy with Zentek - ised-isde.canada.ca

(1 days ago) WEBTesting showed the ZenGUARD™ technology increased VFE of a standard MERV 8 filter by almost 5 times in a single air exchange, with no impact to airflow rates, far exceeding …

https://ised-isde.canada.ca/site/innovative-solutions-canada/en/helping-canadians-breathe-easy-zentek

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