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Scale-Up and Post-Approval Changes - SUPAC Guidance - 0 views

www.onlinecompliancepanel.com/...~product_id=500846

FDA SUPAC Guidance Regulatory Compliance Risk Based CMC

shared by Online Compliance on 16 Apr 15 - No Cached

Online Compliance on 16 Apr 15

Understand what kind of documentation is required while scaling-up or changing the equipment in your process, to comply with FDA SUPAC Guidance.

<div class="cArrow"> </div><div class="cContentInner">Understand what kind of documentation is required while scaling-up or changing the equipment in your process, to comply with FDA SUPAC Guidance. </div>

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Drug Master Files-Requirements for GDUFA - 0 views

www.onlinecompliancepanel.com/...~product_id=500777

fda approval process guidelines Generic Drug User Fee Amendments food safety regulations

shared by Online Compliance on 24 Feb 15 - No Cached

Online Compliance on 24 Feb 15

Webinar on GDUFA, know its background, Self-identification and fee requirements, how to achieve DMF “Available for Reference” status and more.

<div class="cArrow"> </div><div class="cContentInner">Webinar on GDUFA, know its background, Self-identification and fee requirements, how to achieve DMF “Available for Reference” status and more.</div>

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