FDAnews Announces Virtual MDSAP Audits in the Era of COVID-19: What to Know and Do to Pass Virtual Audits Webinar Jan. 21, 2021

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WCG FDAnews

Virtual MDSAP Audits in the Era of COVID-19:
What to Know and Do to Pass Virtual Audits
An FDAnews Webinar
Thursday, Jan. 21, 2021, 1:30 p.m.-3:00 p.m. EST
https://www.fdanews.com/virtualmdsap

How does one prepare for virtual Medical Device Single Audit Program (MDSAP) audits? Successfully manage remote audits in the era of COVID-19 with this webinar.

Attendees will learn how virtual MDSAP audits are being conducted and what must be done to ensure effective ones. Get best practices for managing virtual audits and how to mitigate their challenges. Learn how to best to share documentation, work with and communicate with remote auditors to achieve success.

Christy Coleman, OD, MPH, the Vice President of Regulatory at Irrimax Corporation, will share:

  • 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)

         o When remote audits can and cannot be conducted
         o Procedures established by auditing organizations to define the technology and tools required for remote audits
         o How auditing organizations handle obstacles and technical difficulties encountered during remote audits
         o 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

         o How to prepare virtual communication and document-sharing technologies for the audit
         o How to ensure effective video and audio communications with the auditor
         o How to share documentation with the remote auditor
         o 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 the 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.

Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special multisite discount.

Webinar Details:
Virtual MDSAP Audits in the Era of COVID-19:
What to Know and Do to Pass Virtual Audits
An FDAnews Webinar
Thursday, Jan. 21, 2021, 1:30 p.m.-3:00 p.m. EST
https://www.fdanews.com/virtualmdsap
Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/virtualmdsap
By phone: 888.838.5578 or 703.538.7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations

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