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FDA 483 Observations in the Laboratory What went wrong How can they be avoided

9/17/2013 10:00 AM - 11:30 AM

Overview: In order to proactively address areas of concern to the FDA and other regulators, All units within each pharmaceutical firm should review recent regulatory observations and proactively establish programs or systems to address the regulatory concerns.

In this webinar we will focus on the laboratory and recent FDA laboratory based operations. We will review observations, identify the real issue and suggest actions to prevent similar observations in other laboratories.

Why you should attend: An FDA 483 observation can have an impact on any unit within a firm and laboratories have received more than their share. Since the early 1990s, the investigators have focused on challenges to the firms' laboratory control system. Laboratories should proactively address issues of concern to the regulators. In this webinar we will review and discuss FDA 483 laboratory operation based observations, analyze the cause and propose measures to prevent similar observation on other laboratories.

Areas Covered in the Session:


Inspectional Guidances

Laboratory controls

Specification, standards, sampling plans, test procedures

Conformance to specifications

Complete data


Following procedures

Who will benefit: The following individuals and disciplines will benefit from this webinar:

Director, Quality Control

Director, Quality Assurance

Manager, Quality Control

Quality Control Analyst

John G. (Jerry) Lanese, Ph.D. CMC is the president of The Lanese Group, Inc, an independent consulting service provider that specializes in Quality Systems and Laboratory Controls. Jerry has taught at the college level and worked in various Quality Control and Quality Assurance roles in small and large pharmaceutical firms.

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA

USA Phone:800-447-9407

Fax: 302-288-6884

Event Link -

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