FDA 483 Observations in the Laboratory. What went wrong? How can they be avoided? - Webinar By GlobalCompliancePanel 2011

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:

• Regulations
  
• Inspectional Guidances
  
• Laboratory controls
  
• Specification, standards, sampling plans, test procedures
  
• Conformance to specifications
  
• Complete data
  
• OOS
  
• 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