Through the Eyes of an Auditor
July 24, 2018 - Online Event ON CAWebinar Compliance
info@webinarcompliance.com
Phone:416-915-4438/ 58
Internal and external audits are an integral part of running a medical device or biotechnology manufacturing operation. To be sure, auditors must follow standards such as ISO 13485, ISO 14971, or regulations such as 21 CFR Part 820. Additionally, an auditor has personal experiences of what a state of control looks like and has visited sufficient places to know what to look for. Anyone in a medical device setting must be prepared for an audit at any and all times. This webinar provides insight into the kinds of clues an auditor might use in determining what areas to focus on. It isn’t intended to cover all regulations and standards. What it does cover is the general mental checklist that will influence how well an audit goes, as well as the culture and environment a company’s management must encourage so that impression is a good to excellent one.