问答

Statement: The content of this Q&A reflects the current views of CQAF, for mutual learning and exchange among industry colleagues.

Audit is carried out by personnel from other departments, but is it okay for the internal audit plan, plan, and report to be developed and approved by the Pharmacovigilance Department
2023-10-18 18:08:16
Do users need to conduct on-site audits of third-party PV suppliers?
2023-10-18 18:07:59
Who should serve as internal auditors? What are the requirements for the qualifications of internal auditors?
2023-10-18 18:07:39
关于人员资质证明文件，除了简历和培训证书等。公司是否需要设置考核评估人员开展各个工作的资质？比如是否需要设置专门的考核以确认新入职的药物警戒医生是否有撰写PBRER的资质？

2023-10-18 18:07:20
关于培训，我们目前有年度计划、培训签到表、效果评估表。请问培训记录表是指什么表？培训记录表是必须的吗？

2023-10-18 18:07:02
企业设置了药物警戒部，规定为专职部门，在组织架构中体现为与质量部，销售部等并列的独立部门。实际情况是药物警戒负责人为质量部副职。是否合规？

2023-10-18 18:06:43

Prev 14 15 16 17 18 19 Next