Laboratory Regulations and Guidance Training - Live Webinars, Recordings & CDs

This course will detail various sterilization methods and various approaches for the validation of a sterilization process.

This regulatory training will help attendees understand key benefits for implementing and maintaining an effective global regulatory plan. Attendees will also gain exposure to the elements and a methodology for global regulatory plan development and maintenance.

This training program will discuss why it is important for you to be better aware of and to become better acquainted with FDA inspection best practices. In particular, the webinar will detail a list of Dos and Don’ts before, during and after the inspection.

This training program will detail best practices for documentation, list types of documents, and highlight key documentation requirements. Documentation is essential where FDA and other health authority regulations impose a special recordkeeping burden. In these industries, documentation serves both the scientific and compliance needs, and Good Documentation Practices (GDPs) are a set of activities that enable you to record your data and hand-written entries in a legible, traceable and reproducible manner.

This webinar will teach attendees how to prepare for, manage, and follow up on FDA inspections. It will discuss common pitfalls to avoid during an inspection.

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. It will highlight differences between quality control and quality assessment and the proper methods to meet CLIA guidelines.

This FDA guidance training on RUO (Research Use Only) and IUO (Investigational Use Only) products will enumerate FDA requirements for research use only and investigational use only IVD products. The webinar instructor, an industry expert, will highlight appropriate labeling and distribution practices for RUO and IUO products and detail instructions for use of an IVD product labeled RUO or IUO.

This webinar will provide an overview of regulations for the use of social media for promoting FDA regulated products. Attendees will learn how to comply with these regulations and avoid enforcement actions.

This webinar will elaborate the scope and content of the recent FDA guidance on validation of analytical methods. The webinar will also illustrate the lifecycle management of analytical procedures and train attendees on documentation requirements and verification of submitted methods.

This trade webinar will explain the complex US entry process so companies that import FDA regulated products will benefit from a better understanding of how the process works. It will discuss factors and actions that can lead to an import shipment being delayed or not allowed entry into the USA.

This training on using certified reference material in analytical laboratories will cover FDA and international requirements for selection, purchasing, testing, storage and use of (certified) reference material.

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 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 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.