Aditi Thakur from CDER’s Office of Pharmaceutical Quality and Tara Gooen Bizjak from CDER’s Office of Compliance discuss applying GMPs to the quality assessment of the applications and enforcement trends. Thakur covers integration of review, inspection, surveillance and research across the product lifecycle. Gooen Bizjak emphasizes the importance of selecting the right manufacturers who perform effective process validation/development work and use quality risk management tools and quality agreements to effectively manage and enable changes as they occur.
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