Packaging Pharmaceuticals, Medical Devices, and Combination Products

The importance of a product’s primary package cannot be overstated. From material selection to closures, to stability, to the packaging process itself, a multitude of critical decisions must be made in order to develop a quality package. Shortcomings or a lack of understanding in any of these important considerations can render a final package unacceptable. No pharmaceutical, medical device, cosmetic, or personal care product enters the marketplace without a package. This package not only ensures the product stability but can also ensure proper dosing or enhance product appearance. With the multitude of packaging options available, it can be a daunting task to select the best package option without extensive knowledge of the benefits and disadvantages for various options. This 12-hour intensive, accredited, course will address how packaging for pharmaceutical, medical devices, combination products and other regulated products are developed. The course will explore how to design for excellence by considering regulatory and product requirements, materials use and handling, storage, and shipping risk factors. The importance of specifications and testing will be emphasized. The requirements for production testing and distribution hazards will be reviewed from a product, manufacturing, and potential regulatory standpoint. The current packaging requirements to satisfy regulatory authorities will be examined from a worldwide perspective. Recent concerns on counterfeiting effects and methods being used to reduce potential issues will also be addressed.