This training will cover compliance requirements for running clinical trials in pediatrics, particularly in the EU to comply with the EU ethical considerations guidance for running clinical trials in pediatrics.
This webinar will help clinical laboratories, analyzing samples from clinical trials, understand the compliance requirements concerning ICH GCP for FDA and EMA compliance.
The rapid expansion and broad applicability of software functions / applications deployed on mobile or other general-purpose computing platforms has created concerns with industry and the US FDA. This has resulted in the FDA focusing on the subset of software functions dealing with medical issues which the Agency intends to apply its authority. What are these issues / software app claims, and how will this affect the medical device industry.
This session will include the requirements for all of the complaint handling responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback. Also covered will be the application of risk management to a complaint handling system, and a specific risk management system explained.
This training program will offer attendees an understanding of human errors in GMP related environments, factors and causes, and control measures to be put in place to reduce the same.
This course provides medical device/pharmaceutical professionals with the information they need to prepare for and manage any type of FDA inspection. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the validation essentials for medical device manufacturers. You’ll learn about what processes needed to be validated and what steps you need to take to validate processes. Validation is a powerful tool in understanding, optimizing, and controlling manufacturing processes. We’ll cover the essential steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.
In this webinar, you will how to manage General Safety and Performance Requirements (GSPRs) according to EU MDR 2017/745 Annex I for full compliance with new EU Medical Device Regulation mandatory starting 26-May-2021
Research Billing is complex and often manual process for many health systems. Attendees will learn how system integrations can improve the quality of a health care system’s compliance program
This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.
Events in the world are affecting how we do business with travel restrictions we face new uncharted waters, Companies need to maintain their certifications / suppler status and are required to be audited either by a CB or a customer periodically. To protect the client and the auditor remote auditing has been proposed as the solution. The big question is how do we prepare for a remote audit? What are some challenges and how do we address them? Some guidelines have been flowed down from Certifying Bodies to their auditors. This session will share those guidelines and help you prepare for a successful remote audit.
This training program will provide a comprehensive look at the changes in the new access rights under HIPAA and CLIA regulations and prepare attendees for the process of incorporating the changes into how they do business in their facilities. It will also explain how the HIPAA audit and enforcement activities are now being increased and what needs to be done to survive a HIPAA audit.
This Quality management training will provide valuable assistance in process development include in Equipment Validation, Tracking, Calibration, and Preventive Maintenance.
This 90-minute webinar will examine in detail the U.S. FDA and EU MDD requirements for DHFs, DMRs, DHRs, and TF/DDs - their formats, content, and their commonalities, differences, interrelationships, and similarities.
The one-hour training discusses the major elements that should be considered prior to, during, and after the performance of a dose audit. The training is designed to instruct attendees on how to critically think about the preparation, performance, reporting, and responding to failures for a dose audit.
In this webinar, you will learn how to classify medical devices according to EU MDR 2017/745 Annex VIII for full compliance with new EU Medical Device Regulation mandatory starting 26-May-2021
Corrective and preventive action (CAPA) is a process of the quality management system that begins with the identification of a problem (or opportunity), goes through a series of steps including identification of the root causes and deployment and verification of a solution, and documentation and deployment of lessons learned. The deliverables include not only elimination of the problem at hand, or realization of the opportunity, but application of the best practices learned to related activities.
