• To discuss the mechanics of conducting a recall with a focus on the practical side of this activity and the level of detail the FDA requirements will be.  This will cover both U.S and International requirements.

• (21 CFR Sections 806 and 810)
• How to decide if a recall is necessary
• What the FDA expectations will be?
• Effectively following up on the recall
• Closing the recall activity
• Script development for discussions with customers affected by the recall
• Practice in interpreting regulations
• Develop a usable resume that adapts the participants' current skills to the Biomedical industry
• Interact with industry professionals on a personal basis

Course Details