One incident happened we given CAPA for that but, it happens repeatedly what about CAPA effectiveness?
This clearly indicates that the identified CAPA
This clearly indicates that identified CAPA is not effective. Please again investigate in to the matter and find out why is CAPA not effective. And accordingly you can revise CAPA and implement. If required you may have to do major changes in Quality System, relevant SOP or change in the job responsibilities of the operator or the person who is repeatadly deviating from the established procedure. Only retraining and councelling may not be enough.
CAPAs must be identified and implemented very carefully.
Very correct answer: recurrence of the incident proves ineffectiveness of your CAPA
Hi everyone! I am new here (just registered myself) and need help I am writing my master thesis which is about audits in Clinical trials and would like to ask you 1. If you have some good examples for audit findings-root cause-CAPA plan-successful or unsuccessful-both will be useful for me as I would like to give several examples for my practical part. And 2) I would like to summarize most common audit findings-gnerally from system audits and site audits I will appreciate you help. My email is [email protected] (no confidential information is needed
Thanks for your feedback. I will send you examples of QA audit findings of Clinical trials very soon on your e-mail Id.
Please let me know your background and what type of thesis are you writing and its submission to which academic institute / University? What is the title subject of your thesis>
Dear Sunil, Many thanks! Really appreciate. About me-currently I am a CRA, working in Sofia, Bulgaria. I have more than 3 years experience in this position, but for good or bad -no experience with audits by this time My master thesis title is “Audits in Clinical trial” and particularly I would like to focus on finding-RCA and CAPA -plans in the main part-examples from real life. It will be submitted in Medical University Sofia, where I am studying brand new master program “Management of Clinical Trials”
Thanks for your message about your thesis in Clinical trials. I will shortly send you the required information step by step in several portions.
My background is as follows,
I was working as Vice President -QA & Regulatory in a leading Clinical Rersearch Otrganization in India having GCP environment where we had conducted several Bioavailability & Bioequivalence studies of generic drug products and Clinical trials on human volunteers. These included phase-1, 2, 3 & 4 clinical studies on new drug molecules for submission to the regulatory authorities such as USFDA, EMA, MHRA-UK, ANVISA-Brazul, ANSM-France, WHO-Geneva, Thai-MOH, CDSCO-India and several others.
I have also worked in several pharmaceutical manufacturing companies in the departments of QC, QA & Regulatory under GMP & GLP environment.