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Combination Product GMP Compliance: Understanding the Basis for Developing a Compliance Strategy that Works for YOU!
Manufacturing a drug or device is hard enough — even for companies with big budgets. For makers of combination products things can get messy in a hurry. In a 46-page draft guidance released in January, FDA clarified a 2013 final rule that specifies how combination product manufacturers should comply.
The heart of the guidance is the FDA’s view that product makers have two options for GMP compliance: satisfy all device and drug GMPs, or implement a streamlined quality system that focuses primarily on one but incorporates elements of the other. Which approach a manufacturer makes should not only make good compliance sense but also good business sense.
Noted combination products expert Mary C Getz, VP NSF Medical Device Consulting, will guide manufacturers through the options that a company can take in developing a compliance strategy.
This presenation will focus on:
Deciding what to do is complicated and that regardless of total drug and QSR compliance or streamlined approach, manufacturers need to view their product in its entirety and not just as two separate components that get “slapped together” at the final hour. Let an expert help guide you through some of the challenges so that you have a Compliance Strategy that works for you.
This course will be of benefit:
From the following companies:
Mary C Getz, PhD is the Vice President of Quality Systems, Medical Devices Consulting for NSF Health Science. Prior to joining NSF, she had over 25 years of experience within both Pharmaceutical and Medical Device Industries. During her tenure in industry, Mary held various roles within Fortune 500 Companies in Quality, Compliance, and Regulatory Affairs organizations and had a proven track record of success as VP and SVP of Quality and Compliance. Mary has a PhD in Microbiology and Molecular Genetics from Rutgers, as well as a Black Belt Certification in Six Sigma, which she uses along with her considerable experience to help clients’ remediate and build strong Quality and Compliance programs.
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