Critical Process Cleaning and Cleaning Validation
January 14 - 16, 2009
Boca Raton, FL
Online Registration is not available at this time. Click on the Notify Me button to the left to be notified when online registration is available.
This course is available as a client site course. Please click here for more information.
Who Should Attend
This course is intended for professionals in:
• 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
practices 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 and case histories will be presented.
Recent regulatory expectations and guidance from US and
Europe will be discussed in depth.
For participants experienced on this subject, this practical
course will help to better audit, evaluate and develop their
own or third party cleaning programs to balance production
objectives against QA/validation objectives. The idea is to
first achieve an effective, reliable cleaning process defined
parametrically, then generate sufficient data 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 evaluation by participant teams or for inclusion
in “Participant Problem Clinic” on the second day.
Other Courses of Interest
Biosafety of Biological Drug Products
Jun 04 2009, New Brunswick, NJ
Applied cGMPs for Pharmaceutical and Allied Industries
Mar 23 2009, Burlingame, CA
Clean Room Technology
Endotoxin Testing: Drugs, Medical Devices and Biopharmaceuticals
Environmental Control and Monitoring
Microbiological Control and Validation
May 18 2009, Burlingame, CA
Microbiological Quality of Water-Based Consumer Products
Root Cause Investigation for CAPA
Apr 15 2009, Burlingame, CA
Sterile Products: Formulation, Manufacture and Quality Assurance
Apr 06 2009, Burlingame, CA
Sterilization in the Pharmaceutical Industry
Sterilization Technologies and Process Validation
Related Industries