Combination Drug/Device Products CGMPs – Final Rule


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Understand the FDA's Final Rule for cGMPs for Combination Drug/ Device Products

To achieve compliance and to remain compliant with the applicable cGMP requirements for combination products, it is very crucial for executives and managers to understand and accurately interpret the applicable requirements so that compliance to cGMP requirements can be adequately and sustainably achieved. The current Good Manufacturing Practice (cGMP) requirements for combination products are set forth in 21 CFR Part 4.

This DVD, by expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA is intended to discuss US FDA Final Rule for current Good Manufacturing Practice for combination products. In particular, it is intended to talk about what every executive and senior manager must know.

Session Highlights

Applicable Laws and Regulations
Key Terms
Current Good Manufacturing Practice (cGMP) Requirements for Combination Products
cGMP Requirements for a Co-Packaged or Single entity Combination Product
Implementing Compliance to Quality System Regulations
Implementing Compliance to Drug cGMP Requirements


Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (). Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.