In this webinar we will apply one aspect of this proactive approach, the review regulatory requirements and analysis of 483 and Warning Letter observations to determine if similar observations could be made in the participants facility and provide a stimulus to initiate preventive actions.
Why should you Attend:
In this webinar the discussion will begin by identifying non-conformances most often cited by the FDA and the pertinent regulation. This will be followed by a discussion of specific observations that relate to the laboratory cited in Warning Letters and FDA 483s.
Areas Covered in the Session:
System Based Inspection Guidance
Laboratory Control System
Most common observations in the laboratory
483 and Warning letter observations
Analysis of observations
Areas for preventive action
Who Will Benefit:
Quality Control Laboratory Managers
Quality Control Laboratory Supervisors
Quality Control Analysts
Quality Control Microbiologists
Quality Assurance Manages
John (Jerry) Lanese is an independent consultant with a focus on Laboratory Controls, Quality Systems and the components of an effective Quality System as they apply to the pharmaceutical and medical device industries and their suppliers to those industries. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan.
Event Fee: One Dial-in One Attendee Price: US$150.00
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