Managing External Audits & Inspections
This webinar presents an overview of what organizations should be doing to be audit-ready. Learn to be in control during the audit and prepare to respond to any audit report findings.
June 2, 2020
10:00 AM PDT | 01:00 PM EDT
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Product Id : 503132
Live: One Dial-in One Attendee
Corporate Live: Any number of participants
Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
External audits often create a sense of dread or even panic. This is often followed by a frenzied scramble to get everything straightened out, cleaned up, or hidden away that might be cited by the Auditor.
Then there's the frantic review of documents and records to see if there are any "skeletons in the closet" to either steer the Audit away from or be prepared to explain.
And, once the Auditor is on site, the stress continues as they take control of your operations for days or even weeks. While there is a lot at stake during an audit, well-run organizations with an effective quality management system should actually feel confident rather than panicked.
This webinar presents an overview of what organizations should be doing to be audit-ready, in control during the audit, and prepared to respond to any audit report findings.
Audits are a chance to demonstrate the organization's competency. Knowing how to prepare, act, and respond is the key to actually being competent.
Why should you Attend:
Areas Covered in the Session:
- Is your organization always audit-ready or do audit notifications send your organization into a panic?
- Do you treat audits and inspections as passive events where the Auditor/Inspector is in charge?
- Do you know the three things the Auditor/Inspector is looking for?
- Have you insured that you already know what an Auditor/Inspector may find nonconforming, and are already working on corrective actions?
- Does everyone who might interact with the Auditor/Inspector know what to expect, what to do, and what not to do?
- Does the audit report leave you wondering whether, when, or how to respond?
Who Will Benefit:
- Types of external audits/inspections
- Being audit-ready
- What to expect and do before an audit
- What to expect during the audit
- Managing the audit and the Auditor
- Do's and Don'ts
- What to do after the audit
- Quality Manager
- Quality Director
- Quality Systems Specialist
- Quality Engineer
- Regulatory Affairs Manager
- Regulatory Affairs Director
- Regulatory Affairs Specialist
Steve Gompertz is a leader in Quality Systems management with over 25 years' experience in the life-science industry.
His career includes roles in quality systems development and implementation, project management, engineering automation, configuration management, audit, and software development for companies including Pelican BioThermal, St. Jude Medical, Boston Scientific, Medtronic, Vital Images, and Control Data. He is currently President of Quality Management Systems Potential LLC, a consulting firm focusing on medical device quality.
Steve also helped develop and is an Adjunct Instructor in St. Cloud State University's Master of Science in Medical Technology Quality program.
He holds a B.S. in Mechanical Engineering from Lehigh University, and certifications in quality management, biomedical auditing, regulatory affairs, project management, and configuration management.