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33607 Conferences

Approaching unknown cause laboratory investigations for pharmaceutical products using lean tools

Added by Referral on 2011-02-14

Conference Dates:

Start Date Start Date: 2011-03-17

Conference Contact Info:

Contact Person Contact Person: Referral
Email Email: referral@complianceonline.com
Address Address: 2600 E. Bayshore Road, Online Event,Palo Alto, California, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

Understand the requirements for investigations when dealing with pharmaceutical drug substances and products; to understand how to effectively control and conduct a laboratory investigation for unknown causes.

Why Should You Attend:

When an out of specification or out of trend result is obtained on an active pharmaceutical ingredient or a pharmaceutical product, both ICH and CFR guidance indicates a need for investigation. At times, the root cause is easily identified and the investigation is conducted swiftly. However, when the root cause cannot be easily accessed by initial review, it can be frustrating to determine the appropriate path for the investigation.

The recent movement of bringing lean and six sigma projects into industry has had a surprising positive side effect. The tools of lean assessment of issues and problems are also excellent tools to conduct laboratory investigations. This training will give guidance on how to break open an issue and will demonstrate the use of some tools for evaluating problem spots. It will also demonstrate how lean tools can aid in establishing as well as controlling the breadth of an investigation.

Note: Use this promocode(117660) for 10% discount.
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