Laboratory Regulatory Compliance Training - Live Webinars, Recordings & CDs

This training program will provide professionals with essential elements of CAPA investigations to assure compliance with regulatory requirements. The corrective and preventive action (CAPA) program is an essential element of a compliant quality management system, as required by international regulations and voluntary standards. Investigations are the backbone of the CAPA program.

This training program will focus on understanding and accepting our respective responsibilities to help ensure that our food supply is safe by pursuing a food safety culture locally, nationally and globally.

This training program will discuss key terms and responsibilities related to FDA inspections and the purpose of the BIMO inspection program. It will also review the general purpose and overall process of an FDA inspection and enhance your inspection preparation strategies.

This training program will provide a review of the current testing requirements and discuss what happened to the old 87/91 LAL Guidance for Industry proposed guidance. The program will also discuss how to transition from one bacterial endotoxin test to another—understanding the RPT (Rabbit Pyrogen Test). Participants will also gain a clearer perspective of the Monocyte Activation Test (MAT).

This training program will provide attendees with the ultimate set of tools in order to help their firms properly create User Requirement Specifications (URS) for Computer Systems Validation (CSV) with emphasis on current industry trends in this particular area as well as current Food and Drug Administration (FDA) regulatory trends and enforcement activity.

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.

Attendees will come away from the training program with the tools they need to understand the various types of enclosures and how to select the correct type of enclosure for their process in order to meet regulations, protect the product, and ensure worker safety. The course is apt for personnel in FDA regulated industries who want to learn about what enclosure is best suited for their process and why.

This webinar will review FDA’s regulations related to suppliers in manufacture of drugs, biologics and medical devices. It will discuss the current regulations, guidance documents and best practices for supplier management and enforceable quality agreement using case studies for a variety of scenarios. Common FDA audit findings will be discussed.

This training program will dispel mistaken paradigms regarding the risk based approach to water system lifecycle. It will detail how to eliminate variability – the cause of most deviations. Attendees will learn how to capitalize on the advantages of online analytical instrumentation (chemical and microbiological rapid methods).

This course will detail various sterilization methods and various approaches for the validation of a sterilization process.

This regulatory training will help attendees understand key benefits for implementing and maintaining an effective global regulatory plan. Attendees will also gain exposure to the elements and a methodology for global regulatory plan development and maintenance.

This training program will discuss why it is important for you to be better aware of and to become better acquainted with FDA inspection best practices. In particular, the webinar will detail a list of Dos and Don’ts before, during and after the inspection.

This training program will detail best practices for documentation, list types of documents, and highlight key documentation requirements. Documentation is essential where FDA and other health authority regulations impose a special recordkeeping burden. In these industries, documentation serves both the scientific and compliance needs, and Good Documentation Practices (GDPs) are a set of activities that enable you to record your data and hand-written entries in a legible, traceable and reproducible manner.

This webinar will teach attendees how to prepare for, manage, and follow up on FDA inspections. It will discuss common pitfalls to avoid during an inspection.

This Clinical Laboratory Improvement Amendments (CLIA) training will be valuable to CLIA regulated, non-waived laboratories that run automated analyzers or semi-quantitative kit tests. It will highlight differences between quality control and quality assessment and the proper methods to meet CLIA guidelines.

This webinar will discuss the current regulatory expectations on how a firm identifies deviations, problems and trends, investigates these to determine the cause, and recommends corrective and preventive actions. It will also explain how to complete these actions and demonstrate how the actions accomplishes the intended correction or prevented the repeated occurrence of the problem.

This FDA guidance training on RUO (Research Use Only) and IUO (Investigational Use Only) products will enumerate FDA requirements for research use only and investigational use only IVD products. The webinar instructor, an industry expert, will highlight appropriate labeling and distribution practices for RUO and IUO products and detail instructions for use of an IVD product labeled RUO or IUO.

This webinar will provide an overview of regulations for the use of social media for promoting FDA regulated products. Attendees will learn how to comply with these regulations and avoid enforcement actions.

In this 90-minute training on laboratory Out-of-specification (OOS) investigations, you will learn what constitutes an OOS observation, what is the OOS investigation process described in the OOS guidance and steps to be taken in the laboratory in the event of an OOS observation.

This webinar will elaborate the scope and content of the recent FDA guidance on validation of analytical methods. The webinar will also illustrate the lifecycle management of analytical procedures and train attendees on documentation requirements and verification of submitted methods.