This two-day course is designed for those who manage, audit, or oversee manufacturing of OTC drug products, and for cosmetic manufacturers with OTC drug products (no dosage) performing their operation under a drug cGMP environment.
This course gives the tools for risk-based implementation and continuous compliance with drug cGMPs for OTC drug product manufacturers, including cosmetic manufacturers that also produce OTC drug products. The course will also cover regulatory expectations as contained in U.S. and International guidelines. It will prepare attendees to assess their current compliance status, develop strategies and plans for remediation of identified gaps, and execute a plan to achieve compliance by initially addressing higher risk items within a reasonable time frame.
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