IA - Objectives, Scope, Criteria Team 2 [18/11/21] by Comply Guru Instructor https://padlet.com/complyguru/undb8qkln5bs914x Your contribution is important! Use your own words to answer each question en-us 2021-10-29 09:03:48 UTC 2021-11-18 09:28:02 UTC hello@padlet.com https://padlet-uploads.storage.googleapis.com/511422770/e3d19b02a56b048228c906795382ed0d/Guru_Front.png https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899025297 the subject of the audit : Manufacturing Process]]> 2021-11-18 08:54:36 UTC https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899025297 The clauses of the standard being audit https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899027622 7.5, 6.2, 8.2, 8.2.5, 8.3.,]]> 2021-11-18 08:55:51 UTC https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899027622 https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899032863 Review past non conformances for completion and effectiveness of CAPA.

]]> 2021-11-18 08:59:12 UTC https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899032863 For cause audit https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899034038 2021-11-18 08:59:57 UTC https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899034038 Audit against internal processes https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899034674 2021-11-18 09:00:19 UTC https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899034674 audit scope is the area to be audited and its borders https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899037680 2021-11-18 09:02:09 UTC https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899037680 Passive https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899039694 Reviewing documents , observing work being performed]]> 2021-11-18 09:03:22 UTC https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899039694 Interactive https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899039985 Interview]]> 2021-11-18 09:03:33 UTC https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899039985 Clauses Boundaries inc location/time https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899040091 7.5, 6.2, 8.2, 8.2.5, 8.3.,
Boundries Purchasing and QC control
Location production 
Time : half day]]> 2021-11-18 09:03:37 UTC https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899040091 remote https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899040211 2021-11-18 09:03:41 UTC https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899040211 product and/or environmental sampling https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899044636 2021-11-18 09:06:34 UTC https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899044636 observation https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899044838 2021-11-18 09:06:41 UTC https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899044838 data analysis https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899045006 2021-11-18 09:06:47 UTC https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899045006 Review QMS documentation https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899045324 2021-11-18 09:07:00 UTC https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899045324 Interview https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899045578 2021-11-18 09:07:10 UTC https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899045578 The goal of the audit https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899062856 Ensure compliance to standard 13485 / MDR is met]]> 2021-11-18 09:17:09 UTC https://padlet.com/complyguru/undb8qkln5bs914x/wish/1899062856