Free On Demand webinar

How to Prepare for and Manage Audits/Inspections across Global Markets

Watch the Webinar

Prior to March 2020, medical device regulatory compliance audits and inspections were typically conducted entirely in person and on site.

Within a matter of months the global pandemic would swell to enormous proportions, forcing medical device regulatory bodies around the world to evolve audit and inspection practices in order to keep the industry afloat.

While the global pandemic has begun to subside, many questions still remain over what it has left in its wake...

What lessons have been learned in terms of medical device regulatory compliance, which new alternative audit and inspection practices will remain, and how will COVID-19 impact the medical device industry moving forward?

In this free, exclusive webinar event, Greenlight Guru founder Jon Speer will moderate a panel of industry experts in a lively discussion about audits and inspections. Attendees will gain valuable and actionable advice from participating panelists who bring a wealth of knowledge to the table from their experience at FDA and auditing organizations around the globe.

This is a must-attend event. Registration is limited — save your spot today!


Specifically this webinar will COVER: 

  • Summary of audit and inspection process pre-COVID
  • Biggest changes regarding audits and inspections post-COVID
  • Biggest impacts on regulatory audits due to the pandemic
  • Expected alternative inspection tools and methods
  • New normal regarding audits and inspections
  • Lessons learned, best practices, and steps to prepare for a smooth audit in the new norm
  • Q&A session

Who should attend?

  • Medical Device Executives
  • Regulatory Affairs Professionals and Management
  • Quality Professionals and Management
  • R&D Engineers and Management



Norbert Stuiber
Global Director Sales & Strategic Marketing, Medical & Health Services

 George Zack

George Zack
Principal and Co-founder
Two Harbors Consulting


Colleen Hittle
ProVeritas Partners

 Steven Niedelman

Steven Niedelman
Lead Quality System and Compliance Consultant
King and Spalding

 Sara Adams

Sara Adams
Medical Device Guru
Greenlight Guru



Jon Speer
Greenlight Guru



King & Spalding logo

King & Spalding helps leading companies advance complex business interests in more than 160 countries. Working across a highly integrated platform of more than 1,200 lawyers in 22 offices globally, we deliver tailored commercial solutions through world-class offerings and an uncompromising approach to quality and service.

Visit their website to learn more.

ProVeritas Partners logo


ProVeritas offers a multitude of subject matter experts with multi-dimensional capabilities who understand how to mitigate risks related to meeting FDA Requirements. Our experts apply these capabilities into effective solutions for your firm through sophisticated, tailored, and successful regulatory solutions.  We harness the collective power of our extensive network of regulatory experts who have the experience, qualifications, and global alliances to provide achievement of positive client outcomes.

Visit their website to learn more.

TÜV SÜD logo


TÜV SÜD is a trusted partner of choice for safety, security and sustainability solutions. Over the last 150 years, we have added value to our partners and customers through a comprehensive portfolio of testing, certification, auditing and advisory services. TÜV SÜD’s global team of over 700 healthcare and medical device experts, engineers and medical doctors are well positioned to help the sector navigate through these uncertain times.

Visit their website to learn more.

Two Harbors Consulting logo


Two Harbors Consulting delivers process and performance improvements tailored to the needs of every business. Our solutions are based on industry frameworks but applied with flexibility and a genuine desire to facilitate success. Our team is certified to perform appraisals and training for CMMI for Development, Services, as well as High Maturity appraisals and includes an Enterprise Data Management Expert and Certified Scrum Masters and certified regulatory lead auditors (9001, 13485).

Visit their website to learn more.


About greenlight guru

Greenlight Guru is the #1 provider of modern cloud-based solutions for the MedTech industry, helping companies bring life-changing products to market faster, more efficiently, and with less risk. Greenlight Guru’s MedTech Suite provides quality management, product development, and clinical data management solutions, along with high-quality training and education required to keep up with the rapidly changing industry regulations. Trusted by over 1,100 medical device companies across the globe, Greenlight Guru has been named by G2 as the #1 Medical QMS Software and by the Inc Magazine as a Best Place to Work.

Visit our homepage to learn more.