Webinar On FDA Approval Process for Combination Products

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Webinar On FDA
Approval Process for Combination Products
Product Id
FDB1224
Category
Food, Drugs Biologics
Scheduled On
Friday, June 20, 2014 at 1300 Hrs
Duration
120 Minutes
Speaker
Albert A. Ghignone
To register for this webinar visit
https//compliancetrainings.com/siteengine/Login.a
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Webinar Description
This 2 hours webinar will provide a comprehensive
understanding of the FDA Combination Product
system. Participants receive a foundation of
knowledge about the FDA Office of Combination
Products, the FDA Combination Product system,
Combination Product submissions, and the
scientific and regulatory principles involved. A
must attend webinar for those who have
Combination Products or are anticipating that
they will be developing Combination Products.
This webinar explains the entire FDA Combination
Product Process and how to navigate the FDA
Combination Product system. This webinar
provides a comprehensive understanding of the FDA
Combination Product Process including the FDA
Office of Combination Products, mode of action,
primary mode of action and how to prepare a
Request for Designation submission. If your
concern is to get your Combination Product on the
USA marketplace this webinar is a must attend for
you.

Areas Covered in the Session

• FDA Office of Combination Products
• FDA Combination Product Process
• How to navigate the FDA Combination Product
  system
• Mode of Action and Primary mode of action
• How to prepare a request for designation
  submission
• How to interact with the FDA Office of
  Combination products
• QA Session

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Who will benefit

• Regulatory Affairs Personnel
• Quality Personnel
• Clinical Personnel
• Research Personnel
• Manufacturing Personnel
• Legal Personnel
• Auditors
• Clinical Research Associates
• Personnel who require a general understanding of
  the USA Combination Product Process.

Speaker Profile
Albert A. Ghignone, MS, RAC is the CEO of AAG
Incorporated. For more than 30 years his focus
has been on FDA related matters in regulatory
affairs, quality assurance and clinical affairs.
He has expertise in dealing with all aspects of
the FDA approval process for drugs, biologics,
medical devices and generic drugs. He has worked
in every major segment of the industry-research,
quality assurance, regulatory affairs,
manufacturing and clinical. He has been
responsible for regulatory submissions,
registrations, FDA liaison, clinical studies,
compliance activities and FDA training. He also
has expertise in the assessment of product and
facilities for due diligence relative to FDA
requirements.
To register visit https//compliancetrainings.com
/SiteEngine/ProductDetailView.aspx?idFDB1224