Life Sciences Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar on outsourcing medical device manufacturing will discuss practical decision making steps you can follow to analyze whether to transfer or invest in keeping production in-house. If you decide to transfer production, then this training will detail the options and next steps to transferring it to the right facility or contract manufacturer.

This water systems webinar training will discuss the myths surrounding microbial monitoring and control approaches and alert you to the pitfalls of believing these myths which could cause over-confidence in a system’s design for microbial control or the suitability of your microbial test methods.

This webinar will discuss regulatory requirements for the medical device software development process and how the documentation needed for MDD technical files and for FDA submission can be developed as part of that process.

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 microbial excursions training will address microbial excursion and the best practices for troubleshooting them. Attendees will gain a new understanding of the complexity of troubleshooting outbreaks and contamination issues based on real life experiences and details of specific excursion.

This FDA software validation training will discuss how to approach strategic software validation planning so as to satisfy FDA by complying to new enforcement initiatives by FDA.

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 medical foods regulatory compliance training will explain the regulatory processes to designate and market a product as medical food. Common issues with FDA compliance will be discussed using case studies and potential solutions will be provided.

This training will provide a solid understanding of FDA Requirements for Device Labeling. Attendees will gain comprehensive knowledge on creation, approval and control of labels and labeling.

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 webinar on Design History Files (DHF) will provide a step-by-step procedure for all medical device companies that are considering the need to bring their product design history files up to date with the current standards.

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 for medical device manufacturers will discuss the CDRH interpretation of the GHTF guidance and how manufacturers should develop process validation plans and conduct production process validation.

This training on ISO 14971:2007 will help you understand the risk management process for medical devices, including risk analysis, risk evaluation, risk control and post-production information.

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.

This 3 hour virtual seminar on China regulatory compliance processes for life science products will discuss the regulatory structure and requirements for compliance against China’s CFDA regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products.

This webinar will help you understand and comply to the Unique Device Identification (UDI) policies, both current and the upcoming FDA requirements for importers, manufacturers and hospitals.

This webinar explains concepts required for a calibration program that satisfies FDA’s Quality System Regulation (QSR), ISO 13485, and ISO 9001. It defines the concepts of accuracy and precision that define the measuring equipment’s requirements. It also explains the meaning of traceability.