Cost Effective and Convenient - in your office or conference room

Validation Evolution:
Are We Abandoning IQ and OQ?
"How to Comply with FDA's New Changes for Process Validation"

Conducted by Lou Angelucci
Industry Expert on Validation and Commissioning

May 1, 2009

Has the FDA abandoned IQ and OQ as steps in qualification?

If so why? Two important documents are out there, reviewed by the FDA and are now in play. One of these is the ASTM E2500 which is a standard reviewed by the FDA telling us how to insure equipment and system suitability for pharmaceutical production. The other document is the new FDA Draft Guidance on Process Validation issued in November 2008.

This seminar will compare the two documents and also investigate what has led to them. Mr. Angelucci will provide a thorough critique of both documents and help you be better able to interpret both documents and apply them in your compliance efforts.

Some of the questions and issues addressed with this presentation are the following:

• How did we get to where we are?
• How do these two new documents compare?
• What are the open issues we must contend with?
• How are the various words and statements defined?
• What is the role of quality?
• What conclusions can be drawn?
• Identifying the common ground and path forward
• Where do we go from here?
• Questions and answer with Lou Angelucci

This seminar will be conducted on the telephone and is presented by Lou Angelucci, an industry expert on Validation and Commissioning.

In this unique web seminar format, lasting just one hour, you will be able to follow along with a PowerPoint presentation, ask questions, and interact with Mr. Angelucci. Mr. Angelucci's qualifications can be found below.

BONUS HANDOUT

FDA Guidance Document - Process Validation: General Principles and Practices issued in November 2008
 

Register now!

Don’t like to order online? Call us at 714-289-1233

All registrations include handout materials. Once you’re registered, you will receive via e-mail (the e-mail address you provide in your registration) the web location to download the handout materials.

We accept Visa, MasterCard, and American Express (AMEX). All prices are in US dollars.

Note: Our shopping cart is set to the highest security level. Please make sure that the address corresponds to the credit card holder. It may result in a declined order if the address doesn't match the address on file for the cardholder named on the credit card.

Please enter your billing information EXACTLY as it appears on your credit card statement.

Get the MP3 file and handout GMP090430E - MP3 audio file and Handout materials Validation Evolution: How to Comply

$397.00

Instructor

Lou Angelucci

Lou Angelucci has close to three decades experience in various aspects of validation and cGMP compliance. Lou has worked for many leading companies in the Pharmaceutical and Biologics industries. He has also worked as a consultant to many companies in these industries. He has traveled extensively overseas to conduct cGMP audits and provide guidance on engineering, design, equipment and process issues.  Lou has extensive experience in cGMP, EU, CSV and CFR Part 11 compliance. He also has extensive experience in commissioning issues, API, Biotech and sterile process validation and Validation Master Planning.  Lou is a frequent lecturer to various industry associations on the topics of cGMP compliance and validation.  He also has authored numerous articles on these subjects, serves on the Board of Directors for the Journal of Validation Technology and is an active member of the ISPE. Lou has a BS degree in Biology, an M.S.E degree in Biomedical Engineering and M.S.E. degree in Engineering Management.