June 2, 2022

How to Survive an FDA Inspection

A big challenge with all medical device manufacturers is to be compliant with any regulations applicable with their product.

In the case of the United States it will include 21 CFR Part 820 which is a set of regulations from the Food and Drug Administration (FDA) that outlines the current good manufacturing practice (CGMP) requirements that manufacturers must follow with regards to their quality system.

As a means of assuring compliance the FDA shall conduct periodic inspections of a medical device manufacturer where if significant issues are identified could result in an FDA Form 483 being issued when an investigator has observed any conditions that in their judgment may be a violation of any 21 CFR Part 820 requirements.

Register for this free, in-depth webinar where Anne Holland, CEO of QA Consulting with more than 20 years experience advising medical device companies on regulatory and quality needs, will share some preventative actions that a medical device company can take to minimize the possibility of receiving a 483 which in some cases could result in a product seizure.

Watch the webinar

QA Consulting Webinar 6-2-22
Specifically, this webinar will cover:
  • Update on current FDA actions and activities.
  • What to do before, during and after an FDA inspection.
  • Do's and don'ts when an FDA inspector is on site.
  • Who should attend an FDA inspection.
  • Best practices on how to respond to tough questions.
Who should attend? 
  • Regulatory Affairs Professionals & Management
  • Quality Professionals and Management
  • Medical Device Executives
  • Product Development Engineers and Management
Register Now  

Hosted by

Etienne Nichols

Medical Device Guru,
Greenlight Guru

Anne Holland
Anne Holland

CEO and Founder,
QA Consulting

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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.


About QA Consulting
QA Consulting is your trusted partner for tailored quality systems, regulatory affairs, and microbiology analysis services throughout the product lifecycle. From start-ups to multinational corporations, discerning medical device manufacturers of all sizes rely on our real-world knowledge, expert documentation, and mastery of industry protocols and procedures to navigate today’s constantly evolving environment.
Whether you require expert consulting services or need to completely outsource your quality or regulatory departments, QA Consulting will tailor pragmatic solutions that ensure your organization exceeds the highest industry standards to help you avoid regulatory roadblocks and guide you along a path to future success.
Visit their website to learn more.

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