Course Description

Packaging Pharmaceuticals, Medical Devices, and Combination Products | A 12 Hour On Demand Course

Online On Demand

Course Offering 210504VO0042
Course ID 42

In-Person Course

Who Should Attend?
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
  • Package Engineering
  • Supplier Development
  • Product Development
  • Logistics
  • Manufacturing
  • Individuals involved with finished package integrity and material would also
     benefit from this course

Course Description
This 12-hours intensive, accredited ON DEMAND course will address how packaging for pharmaceutical, medical devices, combination products and other regulated products are developed. 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 the issues will also be addressed.

Course Director
Jan Gates, President/Principal Packaging Engineer, PackWise Consulting | MSU, Bachelor of Science in Food Science and Master of Science in Packaging

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 packaging 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 in 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. She is on the IoPP (Institute of Packaging Professionals) HealthPack Advisory board and is the Southern California IoPP Co-president.