It is absolutely necessary for all laboratory personnel to be aware of the current compliance issues and the ways of preventing FDA 483 and Warning Letter observations. To do so, they must:
o Be proactively alert
o Identify problem areas, and
o Implement corrective actions in order to prevent regulatory actions.
How do laboratories make this happen? Are there specific methods and procedures that they must keep in mind that will help them be or do all these?
These are what a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will impart. To enroll for this webinar, please log on to http://www.compliance4all.com/control/w_product/~product_id=500991LIVE/
Jerry Lanese, an independent consultant who focuses on Quality Systems and the components of an effective Quality System, will be the speaker at this highly interesting and valuable session, which will be useful to professionals in the laboratory compliance space, such as laboratory managers, laboratory supervisors, laboratory analysts, Quality Assurance managers and Quality Assurance record reviewers.
Step by step understanding
Jerry will start by discussing the non-conformances in the laboratory most often cited by the FDA and the relevant regulation in this regard. He will follow this up with a discussion of specific observations that relate to the laboratory cited in Warning Letters and FDA 483s.
When making an analysis for each observation; he will make participants understand what went wrong that attracted the observation from the FDA. He will explain the systems, procedures and records the laboratory should have in place to prevent a similar observation from the FDA in the future. He will also familiarize the participants with questions that a laboratory manager or an auditor might ask to make sure that appropriate systems, procedures and records are in place and are being followed.
Jerry will cover the following areas during this webinar:
o The most common FDA observations that apply to the laboratory
o The regulations and standards that apply to laboratory operations
o Specific warning letter and 483 observations that apply to laboratory operations including:
o Analysis of deficiencies
o Procedures that will prevent similar observations
o Assessment questions that might be used by a manager to determine if a similar non-conformance exists in the laboratory