FDA 483 Observations in The Laboratory. What Went Wrong? How

Dec 30, 17 FDA 483 Observations in The Laboratory. What Went Wrong? How

FDA 483 Observations in The Laboratory. What Went Wrong? How Can They be Avoided?

To be able to proactively address regions of concern to the FDA and additional regulators, All units within each pharmaceutical strong should review latest regulatory observations and proactively establish programs or systems to handle the regulatory concerns.

In this webinar we will concentrate on the laboratory and latest FDA laboratory based procedures. We will review observations, identify the true issue and suggest activities to avoid similar observations in additional laboratories.

Why you need to attend: An FDA 483 observation can impact on any device within a company and laboratories have obtained more than their talk about. Because the early 1990s, the investigators have centered on difficulties to the companies’ laboratory control program. Laboratories should proactively address problems of concern to the regulators. In this webinar we will review and discuss FDA 483 laboratory procedure centered observations, analyze the reason and propose steps to avoid similar observation on additional laboratories.

Areas Covered in the Program:

Who will benefit: The next individuals and disciplines will reap the benefits of this webinar:

Tuesday, January 10, 201210:00 AM PST 01:00 PM ESTPrice List:Live : $245.00Corporate live : $995.00Recorded : $295.00


Phone: 800-447-9407Fax: 302-288-6884 John G. (Jerry) Lanese, Ph.D. CMC may be the president of The Lanese Group, Inc, an unbiased consulting company that specializes in Quality Systems and Laboratory Settings. Jerry has trained at the faculty level and worked well in a variety of Quality Control and Quality Assurance functions in small and huge pharmaceutical firms. Going back 15 years he offers consulted in an array of tasks from consent decree remedial activities with large pharmaceutical companies to systems advancement for a little component producer. He has lectured across the world to customers and for main seminar companies. He was voted the very best presenter of the entire year in 2001 by the Institute of Validation Technology. In 2008 he received the Kenneth Chapman Industry Acknowledgement Award.GlobalCompliancePanel can be an online teaching gateway delivering top quality regulatory & compliance trainings in a straightforward, affordable and in a user-friendly format.

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