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Validity : 15th Apr'24 to 25th Apr'24
Remote Auditing During a Global Pandemic
- 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
Overview of the webinar
Internal Audit and Supplier Audits are essential for medical device companies to self-identify and mitigate risks. The COVID19 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:
- Remote auditing differs from on-site auditing
- Effective planning to maximize benefits
- Risk Analysis techniques for remote audits
- The balance between Supplier Audits and Acceptance activities
- A long-term strategy for auditing using remote techniques
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
Why should you attend?
Continuous Improvement starts with an 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 COVID19 pandemic. This webinar will highlight ways to maintain your audit program while travel is significantly restricted. In addition, remote auditing can be a long-term strategy to balance risk and still achieve optimal audit information and resulting improvement.
Faculty - Miss.Susanne Manz
Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.