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Live Webinar GMP for combination products, a close look at 21 CFR Part 4 Date: Tue, March 3, 2015 Instructor:Anna Longwell
Time: 10:00 AM PST | 01:00 PM EST Location: Online
Duration: 60 Minutes
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Overview: The topic is the interpretation of the regulation 21 CFR Part 4, and the 2015 guidance which are rules for design and manufacturing controls for combination products. The regulation has been causing confusion since it was finalized in 2013, and this webinar will look at the regulation in terms of its history and the current practice of the Office of Compliance at CDRH.
Areas covered in the session: History of the regulation Definition of terms Types of combination products as FDA defines them for this regulation The role of principal mode of action (PMOA) Requirements for single entity and co-packaged product Modifications/additions to QSR for single entity and co-packaged combination products (examples) Modifications/additions to CGMP for single entity and co-packaged combination products Rules for other kinds of products (container/closure vs combination product)
Who Will Benefit: COOs of Startup Firms Manufacturing Floor Managers QA management (Managers, Directors, VPs)
About Speaker Anna Longwell Principal, Longwell and Associates Anna Longwell is currently principal attorney of the Palo Alto Law firm, Longwell and Associates, which specializes in Food and Drug law.
...more Click here to register for this webinar
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