Who Should Attend?
This training is especially designed for personal involved with packaging process validations for pharmaceutical and medical devices packaging.
Professionals in the following departments will benefit greatly from this training:

  • Package Engineering
  • Product Development 
  • Manufacturing
  • Supply Chain/Logistics
  • Quality/Quality Assurance

Course Description

This intensive, 2-day course provides an overview for packaging validation practices. The training will help ensure the product packaging conforms to its predetermined specification. Targets include consistent quality to the consumer, compliance with regulatory requirements, safety, cost effectiveness, financial and other company benefits.

Controlled processing from translated user requirements to measurable packaging specifications is discussed. There is emphasis is on practical ways to implement packaging validation, using protocols, SOP’s, planning, statistics, process controls and other tools. The Validation-Master Plan/ Protocol, protocols, templates for IQ, OQ and PQ are described.

Course Director
	Jan Gates, President/Principal Packaging Engineer, PackWise Consulting

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