The New Combination Drug/Device Products CGMPs - Final Rule April 22, 2013

This training on combination product regulations will evaluate the chief areas of concern or change in the new CGMP requirements for Combination Products, 21 CFR Part 4, and clarify many of the issues and questions that arise involving combination products.

Why Should You Attend:

This session will provide valuable assistance to all regulated companies in evaluating their existing or proposed CGMP compliance and internal audit emphasis for the production of combination products, as a sub-contractor or primary manufacturer. Once you have recognized the danger and likely locations of potential problem areas, a company can evaluate / perform a gap analysis, and then put in place the necessary fixes to ensure compliance to the new Rule.