Virtual MDSAP Audits in the Era of COVID-19 – Webinar Recording/Transcript
Medical Device Single Audit Program (MDSAP) audits have gone virtual, along with much of how we’re doing business during the pandemic. And virtual MDSAP audits have brought some very real-world challenges.
This presentation will help you understand how to successfully manage remote audits.
Christy Coleman, OD, MPH, the Vice President of Regulatory at Irrimax Corporation, will share how virtual MDSAP audits are being conducted and what you must do to ensure effective ones. Get best practices for managing virtual audits and how to mitigate their challenges. You’ll know how best to share documentation, work with and communicate with remote auditors to achieve success.
- Requirements for remote audits as published in the MDSAP communication “Extension and expansion of temporary extraordinary measures related to MDSAP audit during Covid-19 quarantine orders and travel restrictions – Remote (2020-05 and 2020-07)
- When remote audits can and cannot be conducted
- Procedures established by auditing organizations to define the technology and tools required for remote audits
- How auditing organizations handle obstacles and technical difficulties encountered during remote audits
- How MDSAP audit model elements that cannot be assessed remotely are to be addressed
- Real-world examples of remote MDSAP audit experience
- Best practices for managing remote MDSAP audits
- How to prepare virtual communication and document-sharing technologies for the audit
- How to ensure effective video and audio communications with the auditor
- How to share documentation with the remote auditor
- How to communicate with internal team members remotely during the audit
- Virtual MDSAP audit challenges and how to mitigate them, including issues with video conferencing and file sharing technologies
- Alternatives when technology does not work as expected
Pass your next virtual MDSAP audit by understanding how MDSAP audits are being conducted, the best practices for managing your audit and how to mitigate the challenges associated with virtual audits.
Meet Your Presenter
Christy Coleman, OD, MPH, the Vice President of Regulatory at Irrimax Corporation, is a dedicated clinical, quality and regulatory professional who has served in senior management in both start-up and corporate environments in the medical device industry. Ms. Coleman has more than 20 years of experience in device development, clinical trial design and execution, quality system management, and global regulatory approvals. She has successfully managed remote and on-site FDA, MDSAP, ISO 13485:2016 and international regulatory agency audits.
Who Will Benefit
- Quality and regulatory professionals involved in managing external quality audits
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Jan. 21, 2021