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I'm in the same position. I believe the best thing is to get a training from the publishing software company you are using. ------------------------------ Artur Shchukin RAC, MS, ASQ-CQA Manager, RA/QA New York NY United States ------------------------------

Pharmacovigilance requirement! If you have an NDA/BLA/ANDA then you must submit periodic safety update reports as well as any of the qualified for immediate reporting AEs. The rest is easier, - everything as per Quality Assurance Agreement. ------------------------------ Artur Shchukin RAC, MS, ...

Hello, Can I submit periodic safety reports to FDA using the regular eCTD submission tool (like docubridge etc.)? If we cannot and there is a separate solution for this type of submissions, could you please guide me on what to look for? Thank you for your time. Product: Drug Region: USA -- ...

Temple University RA/QA MS program ------------------------------ Artur Shchukin RAC, MS, ASQ-CQA Manager, RA/QA New York NY United States ------------------------------

If the audit function is not established in the company anyone in the company can audit. Note: The person who will audit needs to meet internal requirements for the auditor; auditor cannot audit the processes that he/she is responsible for. ------------------------------ Artur Shchukin RAC, MS, ASQ-CQA ...