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ICH Stability Requirements: Overcoming the Challenges
Compliance with ICH stability requirements is a necessary step in getting your new drugs approved. Yet drugmakers routinely give it short shrift — to their sorrow.
Failure to comply can trigger an FDA deficiency letter ... resulting in shortened shelf lives ... and worst of all, delay the new drug approval (NDA) process.
But compliance is complex, and the rules often vary from country to country and regulator to regulator. It’s about time someone simplified things.
And someone has.
Order this FDAnews training session that teaches you what you need to know ... in a mere 90 minutes.
Participating from the convenience of your desktop, you’ll cover everything from the basics — what ICH Q1A(R2)-Q1F says, and what it actually means — to tailoring a compliance routine to fit your specific products. You’ll learn:
Ph.D. biochemist Wayland Rushing Ph.D., Director of Scientific Affairs, EAG Labs, will be your guide. Dr. Rushing’s deep background in CMC program design and related topics makes him the right expert for the job.
The NDA process is too important to take chances with. Don’t risk missteps that could cost your organization perhaps millions of dollars in lost opportunity.
Wayland Rushing Ph.D., Director of Scientific Affairs, EAG Labs, is a technical expert in chemistry, manufacturing and controls (CMC) program design, analytical development and regulatory submissions. Over a 15-year career, he has led CMC development programs for a wide array of biopharmaceutical clients including parenterals, inhalation drugs and other pharmaceuticals with complex delivery systems; drafted numerous IND and NDA submissions; and assisted clients facing FDA deficiency letters. He is a subject matter expert in High Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC), and serves on the Parenteral Drug Association (PDA) advisory committees for Technology Transfer and Elastomeric Closures and Seals Presentation Summary. He co-authored PDA TR 65, Technology Transfer.
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