"Laboratory Compliance Training delivered by leading experts through webinars. This section contains compliance training for laboratories in areas - QC Microbiology, Auditing Analytical Laboratories, Clinical Laboratory Improvement Amendments (CLIA), Good Laboratory Practices (GLP), GXP and EPA Laboratories and USP <467>."
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.
Instructor : Barry CraigLiveThursday, June 7, 2012
This 90-minute webinar will clarify your confusion about Test Article Characterization for GLP drug studies. You will learn the correct way to use GMP characterization data in a GLP study, understand how to characterize a medical device as a test article, learn the common mistakes made in test article characterization and the basic requirements for drug and device stability testing.
This webinar will provide a detailed information on the critical requirements of ISO 17025 and recommendations for cost effective implementation. You will learn steps towards laboratory accreditation and how to prepare for an ISO 17025 audit.
This 90-minute webinar will help you to develop a sound bioanalytical process to ensure quality data. It will cover techniques for bioanalytical data management for the purpose of assuring a regulatory agency that the data have been collected, managed, and archived to the highest standards of quality assurance. You will understand the aspects of bioanalysis that can be run according to GLPs and the aspects in which GLPs do not apply.
This webinar provides an easy to follow outline for developing and updating the required HHS Laboratory Compliance Plan for any provider who bills Medicare or Medicaid for services.
This 90-minute webinar will help you understand when a new product being developed begins to fall under the umbrella of a regulated study, teach you the basic principles of GLP study to better separate regulated activities from basic research, provide practical tips on how to keep GLP-related materials separate from non-GLP materials, and manage equipment designated for GLP use.
This webinar on verification of compendial methods will give a good understanding of the revised USP Chapter <1226> and FDA requirements and provide recommendations and tools for effective implementation.
This webinar will identify some of the incorrect lore attached to liquid chromatography and will consider HPLC from a multi-dimensional point of view. It will expand your awareness of fundamental chromatographic phenomena rarely discussed in academic courses so that more informed, efficient, and effective choices can be incorporated into the development effort.
This webinar discusses the high risks of scientific misconduct in regulated studies. You will understand the main issues in producing study results of the highest integrity, learn how managers can implement a system for ensuring accurate and reliable data, understand the "red flags" of questionable data or reporting and develop a plan for identifying the high-risk steps in your operation.
This Validation training will address the regulatory requirements which apply at the various stages of development, and suggest proven strategies for compliant and phase-appropriate analytical method validation
Dan Swanson
Dan Swanson CMA, CIA, CISA, CISSP, CAP President and CEO, Dan Swanson & Associates is a 24-year internal audit veteran, who most recently was director of professional practices at the Institute of Internal Auditors. Prior to the IIA, Swanson was an independent management consultant for over 10 years.
