QC Laboratory Compliance and Meeting FDA Requirements

This two-day course is designed for all persons who work in, supervise, or are involved in the management of pharmaceutical and medical device Quality Control laboratories. The course will also be of benefit to entry-level Quality Assurance professionals and others who audit QC Labs, or whose responsibilities include ensuring lab regulatory compliance. This seminar will also provide participants with an understanding of how to effectively handle out-of-specification results, deviations, laboratory investigations and Corrective and Preventive Actions and certainly how to prepare for QC Lab FDA Inspections as well as current enforcement trends. The seminar is applicable for all levels from senior management to laboratory personnel who need an operating knowledge of the responsibility ascribed by their positions. The seminar will also be of value to manufacturing management who interface with QC or are responsible for QC functions. R&D and product development personnel who work with clinical trial material should also find this course beneficial.