Laboratory Regulatory Compliance Training - Live Webinars, Recordings & CDs

This training on laboratory controls will focus on the systems within a laboratory that will be audited by an FDA investigator using the systems based inspection approach. You will understand the FDA focus on systems and how you might improve procedures in your laboratory to be better prepared for a regulatory agency inspection.

This webinar will clarify the cleaning and material handling requirements outlined in USP 797 and present additional best practice guidelines. It will discuss principles related to the selection, preparation and use of cleaning, disinfection and deactivation agents. The correct sequencing of critical activities related to daily and monthly cleaning of both primary and secondary engineering controls will be presented as well.

This webinar will explain the principles of lean and value stream mapping. Attendees will learn how to apply lean concepts to continuous improvement work across the quality system.

This webinar will focus on the current trends in FDA inspections and guidelines that can be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn how to prepare for an FDA inspection to avoid Warning Letters.

This webinar will provide an overview of OSHA chemical hygiene plan. It will discuss requirements of OSHA’s occupational exposure to hazardous chemicals in the Laboratory Standard (29 CFR 1910.1450), including labeling requirements.

This webinar will explain how to generate a practical and compliant methodology to handle equipment requalification. Attendees will learn about common pitfalls to avoid when requalifying equipment.

This webinar will explain how to implement an Enterprise Resource Planning (ERP) system by integrating a company’s existing quality system. It will cover selection, analysis, initiation, design, validation and test phases, including change control.

This webinar will explain the regulatory path of an in vitro diagnostic (IVD) and Laboratory Developed Test (LDT). It will discuss the CLIA regulations for Laboratory Developed Tests (LDTs), including companion diagnostics (CDx) and how these differ from the FDA’s authority.

This training will outline the possible consequences for failing to promptly and adequately correct significant violations related to cGMPs, new drugs or devices, labeling or other regulatory issues resulting in advisory, administrative and judicial actions.

This webinar will discuss FDA's requirements for medical device supplier management and the controls you need to have in place to ensure compliance with quality. It will cover how to structure a supplier quality agreement and the tools and methods you need for evaluating and assessing suppliers.

This FDA audit training provides an overview of the audit readiness process from internal evaluation of your quality systems to the logistics of the audit itself; with key emphasis placed on equipping you and your team with the skills needed to present expert testimony during interviews with regulators.

The webinar will discuss best QC practices and procedures for verifying the suitability and performance characteristics of microbiological media and reagents.

This webinar will discuss the terms GLP and GMP, their definition, similarities and differences and their application in the biologics or pharmaceuticals development environment.

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.

The Clinical Laboratory Improvement Amendments (CLIA) training will outline the CLIA standards for frequency, methodology and also give examples of practical application.

In this Quality management training you will learn how to develop thorough maintenance documents that are clear and confusion-free and you will discover how to perform and document corrective work in a manner that eliminates ambiguity.

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 lab compliance training will provide 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 virtual seminar will start by evaluating important areas for regulated companies to focus in 2013-2014, based on the U.S. FDA’s recent "Strategic Priorities" initiative. The second-half of the session will discuss how FDA's global initiatives affect supplier chain management and vendor audits and how you can prepare to address them.

This webinar on handling FDA inspectors will discuss practical tips to cope with a difficult FDA compliance officer or inspector. You will learn how to wiggle out of complicated situations, make legal arguments and challenges to the FDA agent and use meeting requests and other tools to ease tensions.