Clinical Laboratory Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar will cover the basic statistics of compliance and non-compliance and how to use a statistical approach to monitor the operation in the laboratory.

This webinar on automating laboratory assays will teach you how to translate an assay that is performed manually to one that is fully automated, with high quality and with proper validation and quality assurance for regulatory purposes.

The webinar will cover the federal regulatory approach to regulating laboratory-developed tests including the role of CLIA, the rationale for and opposition to direct FDA oversight, the goal of possible federal legislation and the prospects for future action by the FDA and/or Congress.

This webinar will help you learn how to validate bioanalytical methods. This session will teach you the pitfalls behind bioanalytical methods validation, allowing one to transition between assays with ease.

In this webinar attendees will learn the key issues and sample requirements (collection methods, sample inhibition and sample volume) for molecular diagnostics and the tools (PCR, DNA fluorescent assays & NGS assays) you need to deal with your laboratory challenges in clinical laboratory.

This training on assay validation will teach you how to validate an assay for clinical diagnostics and transition the assay into the clinical laboratory for diagnostic use.

This webinar will discuss best practices for preparing for an international announced inspection as well as how to be always prepared for those in the US who may be inspected at any time. It also discusses the various roles of the persons who will be assisting during the inspection and suggests how to organize support personnel to aid in keeping the inspection going smoothly and identify and address issues before FDA sees them.

This webinar will cover in detail the regulatory requirements of Clinical Laboratory Improvement Amendments (CLIA). It will also discuss major lab quality standards such as facility administration, general laboratory systems, personnel qualifications & responsibilities, proficiency testing and more.

This webinar will teach you how and when to implement complimentary activities to an outsourced quality function and how to integrate this information into a fully-functioning program.

This webinar will give you the tools you need to maintain a quality supply of media and reagents in a variety of microbiology laboratories. A thorough understanding of the variety of challenges necessary in maintain quality media and reagents will be brought to the fore. This will allow you to perform microbiology testing with confidence.

This webinar training will benefit manufacturers of manufactured products to achieve an effective, robust and compliant SOP and STM which will result in a cost effective and efficient manufacturing and testing of products. A well planned and written SOP or STM will reduce the incidence of out-of-specification (OOS) results, failure, product non-conformances, deviation and invalid assay investigations.

In this training program, attendees will learn how process robustness tools and metrics can be utilized to enhance process understanding and control. The new FDA paradigm is shifting to the expectation that organizations certified by other standards such as ISO and EFfCI demonstrate process robustness. It is the obligation of the primary pharmaceutical provider to ensure process robustness throughout the supply chain.

This training will provide the attendees best practices for handling FDA inspections to avoid form 483 and Warning Letters.