Supply Chain Regulatory
CD and Transcript #1
CD and Transcript #2
From management of your outsourced suppliers to ensuring proper waste management of recalled, rejected and expired pharmaceuticals, you're accountable to the FDA, as well as the EPA, DEA and DOT for each step, from developing to disposing of your drugs. Know your regulatory responsibilities in this cradle-to-grave process.
FDAnews recently examined these important areas in two audioconferences and now you can order them in a two-CD set, Supply Chain Regulatory and save $195.
CD and Transcript #1: Recalled, Rejected and Expired Pharmaceuticals: Ensuring Proper Waste Management
Pharmaceutical waste experts Richard Verch and Charlotte Smith translate RCRA's non-industry-specific requirements into clear guidance on how to discard recalled, rejected and expired pharmaceuticals in this 90-minute audio CD. You'll gain a comprehensive perspective on what state and federal requirements you must meet, and how to identify, label, transport and manage waste pharmaceuticals generated during manufacturing processes. Find out how to defuse problems when products are removed from the market, plus you'll discover what controls are needed to avoid violations on bulk or finished-dose drugs.
CD and Transcript #2: Reduce Supply Chain Risks: How the FDA Expects You to Manage Outsourced Suppliers
It's an iron-clad FDA rule: when you outsource any regulated part of your operation, you're still responsible for the quality and conduct of the supplier. It doesn't matter if the vendor is around the block or around the world: you engage them, you're liable for them — no excuses. Find out how to navigate the unexpected liabilities and legal and regulatory responsibilities from a former top FDA investigator, Martin Browning.
Give your entire team this vital training — no need to travel — with CDs and transcripts from the Supply Chain Regulatory two-CD set. This flexible format is ideal for busy teams — training can take place anywhere and anytime.
The Supply Chain Regulatory two-CD set includes three full hours of practical material you can use now. Order the set for just $595 — you save $195 off of the regular $790 price.
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