Combination Product GMP Compliance - Webinar CD/Transcript

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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 In a 46-page draft guidance released in January, FDA clarified a 2013 final rule that specifies how combination product manufacturers should comply.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:

  • Understanding the FDA’s guidance on the various compliance approaches — full implementation vs streamlined approach — what makes sense for your company.
  • What are some key inputs to developing your Compliance Strategy. Things one should take into consideration are: 1) Product risks and its impact to the product portfolio, 2) How much of your manufacturing is out sourced, 3) Complexity of the combination product being produced, 4) Is this a NDA  line extension or new application and 5) Does a predicate device exist or will this be a PMA.
  • Whether the manufacturers need to update any of their supplier agreements or SOPs in light of the guidance. The FDA describes how to deal with third-party manufacturers, stressing that the sponsor of the combination product is responsible for ensuring all the contractors meet GMPs. But, if a contractor only manufactures the device part of a combination product, then it only has to meet QS regulations.
  • How combination product makers should work with the FDA. Each combination product will be accepted by the agency center that will oversee its premarket review based on its primary mode of action, and that agency will be the lead center and primary point of contact for applicants. Attendees will gather insights on how to work with the center as well as the role OCP (Office of Combination Products) plays in aiding with the approval process.

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:

  • Compliance personnel
  • Regulatory affairs professionals
  • QA/QC personnel
  • Manufacturing executives
  • 510K application specialists

From the following companies:

  • Combination product manufacturers
  • Pharmaceutical companies
  • Biologics companies
  • Device companies
  • Diagnostic companies
  • Contract manufacturing organizations
  • Kit manufacturers and repackages

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.