cGMPs in the Quality Control Laboratory

Since the mid 1980s, the Quality Control Lab oratory has been a prime target for FDA investigators during site inspections. Since that time, investigators have made many 483 observations. Unless the firm reacts very aggressively, the 483 observations will be escalated to Warning Letter citations.

By careful review and analysis of the regulations, inspectional guidance, 483 observations and Warning Letter, internal audit observations and deviations, along with a review of laboratory practice and procedures, a laboratory can proactively identify areas for improvement. The laboratory can then implement actions that will prevent future observations of non-compliance. 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: A large number of FDA 483 observations are made in Quality Control Laboratories. All laboratory personnel should be aware of areas the investigators review and the type of observations that are made in other organizations. With this information, laboratory personnel should be look for ways that their laboratory operations can be improved to avoid these observations.

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. The discussion for each observation will include an analysis of what went wrong, systems, procedures and records the laboratory should have in place that would prevent a similar observation and several questions that a laboratory manager or an auditor might ask to assure that appropriate systems, procedures and records are in place and being followed.

After completion of this seminar, laboratory personnel will be able to critically evaluate key areas in the laboratory operations for compliance and identify areas for improvement.

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

• Quality Control Laboratory Managers
• Quality Control Laboratory Supervisors
• Quality Control Analysts
• Quality Control Microbiologists
• Quality Assurance Manages
• Quality Auditors