Remote Auditing for Medical Device Companies
Product Id : MD3124
Category : FDA Compliance, Medical Devices, Quality
Presenter : Susanne Manz
Scheduled On : February 08 2022 1:00 pm
US/Canada (Eastern Time - ET)
Duration : 60 Minutes
Internal Audit and Supplier Audits are essential for medical device companies to self-identify and mitigate risks. The COVID-19 pandemic has made this important task even more difficult due to travel restrictions. This webinar will provide insights into how to use remote auditing techniques to minimize the risk and maximize the benefits of conducting audits remotely.
In this webinar, we will discuss:
How remote auditing differs from on-site auditing
Effective planning to maximize benefits
Risk Analysis techniques for remote audits
Balance between Supplier Audits and Acceptance activities
A long-term strategy for auditing using remote techniques
Why You Should Attend:
Continuous Improvement starts with awareness of issues and opportunities. And without an effective internal audit program, management lacks awareness of the issues within their quality system. Management is blind to the gaps in the quality system and the risk that poses for the company. Even worse, management is blind to the impact on product quality and risk to the customer. It is essential to continue your audit activities, both internal and supplier, during the COVID-19 pandemic. This webinar will highlight ways to maintain your audit program while travel is significantly restricted.
Areas Covered in the Session :
Background
Audit process basics
Comparison of on-site vs. remote audit
Audit considerations
Interviewing impacts
Remote audit etiquette
Risk Analysis
Do’s and Don’ts
Long term plan
Remote audit strategy
Checklist
Who Should Attend:
Quality Systems Specialists
Document Control Specialists
Quality and Compliance Specialists
Auditors
Auditor Managers
Supplier Auditors
Supplier Managers
Training Specialists
CAPA Specialists
Quality/Compliance managers or directors for Medical Device companies
General Managers wanting to learn how to Management Review and expectations
