Critical Process Cleaning and Cleaning Validation

Process Engineering
Production
Quality Assurance
Validation
Technical and management positions

You should have some familiarity and experience with the basic subject as it applies to research and manufacturing of pharmaceuticals, personal care products, nutritional materials and fine chemicals.

Description:
This course will provide a solid overview of the principles and technology of residue removal and residue measurement on product contact surfaces. It will address the latest issues, industry practices and compliance strategies regarding choice of cleaning techniques, cleaning agents, analytical methods, residue challenges, grouping strategies and validation protocols. Examples of current industry cleaning validation practices and case histories will be presented. Recent FDA inspection history and regulatory comment regarding these issues will be discussed in depth.

This practical course will help participants familiar with this topic to better evaluate and develop their own FDA regulated cleaning programs that balance production objectives against QA/validation objectives. The idea is to first achieve an effective reliable cleaning process, then generate sufficient data and justification without going overboard on the number of samples, the number of analytical tests and the number of qualification studies that have become an excessive burden to many firms.

Participants are encouraged to bring a cleaning problem to the course for inclusion in the “Participant Problem Clinic” on the second day.