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

This webinar on objectionable microorganisms will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.

This training program will focus on U.S. FDA and EU's MDD expect documented risk-based VMP planning, though the CGMPs mention little about it. The course will analyze product V&V versus process/ equipment V&V and how to use DQ, IQ, OQ, PQ, and ASTM E2500 equivalents.

Upon completion of this training program, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, based on the System Development Life Cycle (SDLC) framework. They will have received the guidance on industry best practices necessary to develop a compliant and cost-effective validation program. They will understand the steps for validating laboratory systems, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs. Attendees will gain a good grasp of how to leverage these practices across all systems by creating a standardized program.

This webinar will explain how to implement an effective and FDA compliant GMP training program. It will discuss regulatory requirements and expectations for a well-trained workforce.

This training program will assist those responsible for planning, executing or managing the integration of a business system with any laboratory system governed by FDA regulations. On completing the program, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, and how they apply to any integrated business system.

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).

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 webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. Learn how to identify and avoid potential pitfalls during deviation investigations.

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

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.