COURSE ID 42

Packaging Pharmaceuticals, Medical Devices, and Combination Products

AVAILABLE On-demand
12 Hours

On-Demand

Offering Price
$ 2330
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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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Remember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.

No pharmaceutical, medical device, cosmetic, or personal care product enters the marketplace without a package. This package not only ensures the stability of the product 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 of various options.

This 12-hour intensive, accredited ON DEMAND course will address how packaging for pharmaceutical, medical devices, combination products and other regulated products are developed. This 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 world-wide perspective. Recent concerns on counterfeiting effects and methods being used to reduce potential issues will also be addressed.

“This training is designed for personnel involved with packaging for pharmaceutical, medical devices/combination devices, cosmetics,

and personal care products. Departments may include:

– Quality/Quality Assurance

– Supplier Development

– Package Engineering

– Product Development

– Logistics

– 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 | MSU, Bachelor of Science in Food Science and Master of Science in Packaging

Jan Gates’s Courses
Jan Gates has 30+ years of experience in package engineering for foods, pharmaceuticals, detergent, and medical devices with a BS in Food Science and MS in Packaging from Michigan State University. Her work includes individual contributions and leading teams for packaging material and systems design and development. The packaging design and development have been completed to meet regulatory, product protection, and customer use requirements; also, included are production optimization, validation, and minimal packaging for sustainability. She has previously worked for Bristol Myers Squibb, Conagra, Lever Brothers, Dade Behring, and Abbott Vascular. She currently works as a consultant in her company PackWise Consulting and with Adept Packaging. Ms. Gates works with ASTM D10 and F02 committees for rigid/flexible packaging and environmental package testing. She is also working as a US representative on various ISO TC 122 committees for packaging tests, vocabulary, labeling, and temperature-controlled product shipment. She was a task group lead with AMMI on a US guidance document for compliance with ISO 11607-1/-2 (packaging for terminally sterilized medical devices). The AMMI TIR 22 document has been converted into ISO/TS 16775.