Packaging Process Validations

Pharmaceutical and Medical Devices

Duration: 9 Hours
Course Instructor

Jan Gates

$ 1746
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 integrity of a package depends on the qualification of the packaging equipment, the packaging process, and consistent performance throughout the commercial packaging run. No matter how well the container/closure has been developed, it cannot protect the product as designed if it is not properly sealed and packed. The packaging process validation ensures that packages are sealed and packed correctly.

This intensive, accredited course provides an in-depth overview of 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 an emphasis on practical ways to implement packaging validation, using protocols, SOPs, planning, statistics, process controls, and other tools. The Validation-Master Plan, protocols, and templates for IQ, OQ, and PQ are described.

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

  • Apply and understand an overview level of regulatory requirements for packaging validation in the US and Europe.
  • Identify elements required to execute a packaging process validation.
  • Specify requirements for validating a final closure packaging machine.
  • Contribute to achieving consistent quality for a packaging system.
  • Identify elements and responsibilities needed for executing a packaging process validation.
  • Prepare protocols, templates, documents, and contribute significantly to the validation exercise.
Register Now

You will be redirected to our secure system.

This training is specially designed for personnel involved with packaging process validations for pharmaceutical and medical device packaging. Active participation and questions are encouraged throughout the course presentation.

Professionals in the following departments will benefit greatly from this training:

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

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.

Learn more

We’ve rebranded! CfPA is now COBBLESTONE