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

The training program will cover DEA record-keeping requirements and effective security that a DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced inspection and the auditing methods.

This training program will discuss the concept and application of uncertainty of measurement (MU) as required by ISO/IEC Standard 17025:2005 for laboratory accreditation, from a practical microbiological perspective, using unambiguous language and useful examples.

This training program will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful.

The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.

This Quality management training will provide valuable assistance in process development include in Equipment Validation, Tracking, Calibration, and Preventive Maintenance.

This life science product stability testing webinar will explain, in detail, the requirements of the FDA’s drug stability guidelines that are stipulated for drug products and how to design a product stability testing plan that can be applied to new or modified products in the pharmaceutical, biotechnology and medical device industries.

Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.

This training on bio-analytical methods validation will help you to understand the FDA and EMA guidance for Instrumental, ligand binding and cell-based assays and also review of recent 483s impacting validation.

This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.

This training program will cover in detail the method validation of gas chromatography (GC) and gas chromatography mass spectrometry (GC-MS). It will focus on key elements of validation including injector, column, detection system, data system and much more.

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.

This webinar on laboratory investigation will provide guidance on procedures used in investigating unexpected results for non-clinical and clinical trials and will discuss several suggested procedures, avoiding unnecessary re-analysis.

This training on pharmaceutical laboratory OOS investigations will explain how to recognize and address atypical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate investigations.

This training on using the QbD approach to analytical method lifecycle is designed to provide participants with a lifecycle approach to developing and validating analytical methods and comply with compendial requirements. The webinar presenter will use case studies to illustrate each stage in the process.

In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDLC) methodology used to approach Computer System Validation (CSV), including all of the phases, sequencing of events, deliverables, and documentation requirements.

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 in detail the fundamentals of data integrity including the FDA guidance document. It will teach attendees practical steps to identify and avoid data integrity issues in pharmaceutical laboratory.

This webinar provides understanding of the requirements for residual solvents addressed in ICH, USP, EP and JP and focus on the recent changes to USP <467>. It will also help attendees utilize strategies to minimize the testing and resources required to meet the requirements.

This webinar will explain the final version of USP Chapter <1224> and FDA guidance for conducting and documenting method transfer between laboratories and sites, and provide tools for effective implementation.