Laboratory Testing and Validation Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar on objectionable microorganisms will show how to identify and prevent objectionable microorganisms that are beyond the ones outlined in USP <1111>. Attendees will learn the clinical implications due to presence of objectionable microorganisms.

This method validation training will address the regulatory requirements which apply at the various stages of product development, and suggest proven strategies for compliant and phase-appropriate analytical method validation.

This webinar on HPLC Method Development and Validation will outline similarities and differences in validations, and regulatory requirements, outline approaches specific to HPLC and to the various hyphenated detections systems.

This Validation of Bioanalytical Methods and Procedures training will demonstrate how to validate bioanalytical methods and procedures, in analytical laboratories, for FDA compliance.

This 2-hr Dissolution Instrument Qualification webinar will discuss recent FDA requirements for dissolution instrument qualification and provide practical suggestions to avoid pitfalls in performance of the tests, minimize Performance Verification Test and product failures.

This webinar will focus on the key attributes of an effective cGMP investigation, the role of management, employing quality control tools, CAPA effectiveness checks and Warning Letters associated with cGMP compliance. Attend this training and learn how you can avoid “Failure to Investigate" Observations by FDA.

This Pharmaceutical compliance training will provide instruction on how to establish and maintain a Maintenance & Calibration program for pharmaceutical instrumentation & equipment.

This Laboratory compliance training will review the regulations that cover each environment and present simple and effective strategies for satisfying the requirements. The analytical instruments and equipment used in GXP laboratories must be calibrated and qualified for use in regulated testing. This includes quality control labs attached to cGMP facilities, GLP (Good Laboratory Practices) labs supporting animal toxicology studies and GCP (Good Clinical Practices) labs supporting clinical trials. Additionally, labs supporting EPA studies are also regulated.

This Pharmaceutical training provides guidance to the pharmaceutical industry pertaining to the investigation process for occurrences where laboratory results fall outside of specification limits.

This presentation will cover sections 4 and 5. These contain the requirements for accreditation. ISO 17025 “describes” the elements of a good management system for a laboratory. It also details the principles for a laboratory to ensure technical competence.

This Validation training will guide attendees through the entire process from defining specifications, through developing and implementing validation experiments to FDA compliant documentation.

This 90-minute webinar on laboratory OOS investigations will review the regulatory requirements for an OOS Investigation. You will learn common regulatory pitfalls and how to structure an Investigation report that satisfactorily documents the investigation.

This training will focus on the regulatory requirements for a Corrective and Preventive Actions (CAPA) system. Attendees will learn how to develop an effective CAPA system.

This webinar will explain the cGMP and ICH validation requirements for analytical procedures and discuss key factors that would affect validation process of analytical procedures. It will review the differences between validation and re-validation plan.

This webinar will discuss the common deficiencies in relation to compliance and validation issues that typically found with pharmaceutical Quality Control labs.

Upon completion of this training program, attendees will learn key elements of a change management process, identify key indicators of change and learn the regulatory requirements for change control. This session will also discuss different observations due to the lack of effective change control program.

An Annual GLP training is a requirement for all personnel involved in Good Laboratory Practices (GLP) studies. The webinar course serves both as an initial training for new employees, new to GLP concepts will serving as a refresher course for experienced senior employees. The webinar provides an overview of the GLP to remind the attendees of the regulatory requirements for organizations in which bioanalytical testing is conducted.

This Quality Practices for R&D CMC Laboratories training will associate with generating, reviewing, utilizing or contracting analytical studies for pharmaceutical product development.