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WEBINAR 7 | Pathways for Successful Medical Device Quality Audits

Strategies and best practices for enhancing compliance to quality processes.

✔️ Presented by:
Stephen Ford, Managing Partner at OMEDtech, LLC.
✔️ Moderated by:
Keith Drake, Vice President of Business Development at Galen Data.

The thought of a quality audit may invoke fear and cause aggravation — though it shouldn’t. A successful audit should be seamless and painless. Think of an audit not as a “major chore,” but as a welcomed checkpoint on the road of continuous quality improvement.

OMEDtech — a leading consulting organization providing quality systems, regulatory, and auditing expertise — shares strategies and best practices for integrating audit activities into a company culture centered on the value provided by your quality management system (QMS). Working to QMS procedures, agency regulations, and industry standards result in an effective internal audit program. Thinking like an auditor reduces preparation resources, maximizes the audit’s success, and creates tangible value for your organization.

Key takeaways:
• Encouraging a culture of quality to enable effective audits
• Integrating quality process supporting audit activities
• Areas of focus before, during, after the audit

Contact Galen Data for your healthcare connectivity needs:
👉 https://www.galendata.com/contact/​
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Timestamps:
00:00 Introduction and Webinar Logistics.
01:31 Stephen Ford and OMEDtech Company Overview.
2:47 Galen Cloud Overview.
3:34 Webinar Topics Overview.
5:38 Why the focus on "audits"?
8:24 Typical Reactions to Audits.
9:53 Why Audits?
11:37 What is a "Successful" Audit?
13:55 When do you start preparing for the next successful audit?
14:47 How do you prepare for a successful audit?
24:51 Managing the Audit.
27:08 After the Audit...
28:14 6 Key Points for a Successful Medical Device Audit.
29:02 6 Key Benefits for a Successful Medical Device Audit.
29:24 Cloud Connectivity and Audits.
32:57 Your next steps...
35:34 Questions and Answers.
56:18 Galen Cloud Benefits and Outro.
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