Packaging Pharmaceuticals, Medical Devices, and Combination Products

Duration: 12 Hours
Course Instructor

Jan Gates

$ 2330
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

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 of 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 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 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.

Upon completion of this course, you will be able to:

  • Apply an overview level of understanding regulatory requirements in the US and Europe for packaging and testing.
  • Identify and use basic packaging design and development tools.
  • Assess, compare, and select packaging materials and specifications for use.
  • Specify packages that meet requirements for filling, closing, protection, warehousing, and distribution.
  • Assess packaging material stability requirements testing.
  • Contribute to prevent and solve packaging problems with materials/machinery interfaces and shipping challenges.
  • Promote sustainable packaging choices for use.
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This training is designed for personnel involved with packaging for pharmaceuticals, medical devices/combination devices, cosmetics, and personal care products. Departments may include:

  • Quality/Quality Assurance
  • Supplier Development
  • Logistics
  • Package Engineering
  • Product Development
  • Manufacturing

Individuals involved with finished package integrity and material would also benefit from this course. Active participation and questions are encouraged throughout the course presentation.

Course Instructor


Jan Gates

President/Principal Packaging Engineer, PackWise Consulting

Jan Gates’s Courses


Team Training

When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.

Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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