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

FREE ON-DEMAND WEBINAR
May 28, 2021

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

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

Watch the webinar

Who should attend?

Medical Device Executives
Product Development Engineers and Management
Quality Professionals and Management
Regulatory Affairs Professionals and Management

Hosted by

Moderator:
Jon Speer

Founder,
Greenlight Guru

Presenter:
Norbert Stuiber

Global Director Sales & Strategic Marketing, Medical & Health Services,
TÜV SÜD

Presenter:
George Zack

Principal and Co-founder,
Two Harbors Consulting

Presenter:
Colleen Hittle

Founder,
ProVeritas Partners

Presenter:
Steven Niedelman

Lead Quality System and Compliance Consultant,
King & Spalding

Presenter:
Sara Adams

Medical Device Guru II,
Greenlight Guru

Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies. The end-to-end solution goes beyond traditional QMS needs by integrating cross-functional teams, processes, and data throughout the entire product lifecycle so device makers can proactively overcome execution gaps, streamline compliance, and accelerate market success.

Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster, and with less risk.

Visit our homepage to learn more.

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.

tuv sud 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.

Featured Capabilities:

Featured Capabilities:

Ultimate Guide to Comparing Quality Management System Solutions