Innovative Process Validation Strategies for Medical Devices
Proving Your Processes and Documentation to the FDA
An interactive workshop presented by Ombu Enterprises and FDAnews
This workshop — taught by internationally renowned medical device process validation expert Dan O’Leary — has been designed to provide you with industry best practices to achieve sustainable process validation with regulatory bodies around the world.
Dan has been successfully helping devicemakers large and small conduct and document process validation for more than 20 years. He’s a bona-fide, “been there, done that” instructor.
Rather than sitting through two days of endless PowerPoint slides, this one-of-a-kind workshop breaks you into small groups and features 15 interactive exercises. You’ll learn the theories of process validation and documentation AND how to put them into practice.
You’ll learn proven techniques that include:
How to set process validation parameters: participants will analyze a hypothetical process to determine the input parameters and whether the process should be validated.
Best practices for determining the number of records to inspect — when an FDA investigator asks for records, the number reviewed is determined by a sampling plan in QSIT. This exercise explains how the investigator classifies the records, and estimates the error rate; it is not Z1.4 acceptance sampling.
The proper use of a supplied IQ Checklist: participants will use an example in the GHTF guidance document to determine if all the essential elements for Installation Qualification (IQ) are covered.
How to set up an SPC chart and the proper way to monitor a process: this exercise sets up the control lines to use in x-bar & R charts.
Tips and tricks to determine a DOE alias: in fractional factorial DOE, some of the results have an alias. This exercise shows how to determine the aliases in a design.
Applying HACCP Principles: HACCP is a powerful tool that is underutilized in process validation. This exercise demonstrates its application to a process.
Plus 9 more immediately useful exercises you can take back and implement in your operations.