Dr. Christopher Tudan to speak at the SQA and RQA annual meetings.
Dr. Christopher Tudan to speak at the SQA and RQA annual meetings.
During this Covid season, we do conduct remote audits, and hybrid audits where much of the auditing goals are accomplished remotely, followed by a reduced-scope on-site audit when that can be facilitated and hence provides an interim and final report.
Effective pre-audit functions are undertaken to ensure the sponsor and vendor (auditee) are satisfied with the scope and agenda, and time is taken to ascertain and test data exchange process, audio/visual communications and the virtual facility tour (if pertinent) to provide confidence in the approach, scope of the audit and security of the records. Agreement with both the sponsor and auditee on documents to be reviewed prior and during the audit and on content to be distributed would also be the intent of the pre-audit.
An agenda is also established so as to impact as little as possible the normal operations of the auditee. As much as possible, the auditees portal and communications systems are used, and the Sponsor can be involved as much as agreed.
BioAccurate has experience with remote audits, and as the Covid season is making more amenable, has been facilitating hybrid audits, which may become the norm as things begin to normalize due to cost effectiveness.
“I first met Chris at a workshop where he was presenting on the topic of bioanalysis. Chris is an extremely knowledgeable and enthusiastic teacher. He has the innate ability to engage his audience and describe in simple terms the scientific intricacies and regulatory challenges of conducting LC-MS/MS and immunoassays.”
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