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.
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.
Regulatory Affairs Professionals and Management
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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.