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

 
  November 25, 2010  
     
 
GlobalCompliancePanel, Online Training
2011-01-12


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
 
 
Organized by: GlobalCompliancePanel
Invited Speakers: 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. For the last 15 years he has consulted in a wide range of projects from consent decree remedial actions with large pharmaceutical firms to systems development for a small component manufacturer. He has lectured throughout the world to clients and for major seminar providers. He was voted the best presenter of the year in 2001 by the Institute of Validation Technology. In 2008 he received the Kenneth Chapman Industry Recognition Award.
 
Deadline for Abstracts: 2011-01-12
 
Registration:
Wednesday, January 12, 2011  
10:00 AM PST | 01:00 PM EST
Live live online training only for one participant
Price: $245.00
 
 
 
Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care)
Price: $995.00
 

Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Price: $295.00
E-mail: webinars@globalcompliancepanel.com
 
   
 
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