The recent changes in the requirements for initiating clinical trials within the European Union apply to all clinical trials of medicinal products (including Biologics). This presentation will provide you with an understanding of key updates, major differences, and common trouble spots.
This course will be of benefit to anyone in the life sciences who is interested in 3-D printing as a method for developing a therapeutic product (e.g., medical device, drug delivery system, etc.), including those already using 3-D printing but want a better understanding of FDA’s position on the subject.
The purpose of this training is to present techniques and strategies for auditing computer systems validation documentation for compliance to applicable global regulations, plus internal policies and SOPs. Current issues including cloud systems and data integrity will be discussed.
In this training, you’ll learn the five common areas where device trials tend to fail, plus review actionable steps to help you anticipate potential pitfalls and resolve them before they occur.
This course outlines a beginner’s path in determining if social media is appropriate for a given clinical study, presenting a candid discussion of the challenges in today’s research environment.
While it is important to learn and understand common RCA tools and techniques (e.g., the 5 Whys, Fishbone diagrams), the science of root cause analysis is critical to developing sound corrective and preventative action (CAPA) plans. By attending this session, you will learn, practice, and apply this science to create RCA tools specifically useful for both simple and complex clinical trials, risk management, and issues management.
The establishment of clear roles and responsibilities within & between CRO and sponsor on who assesses, monitors and documents risk management activities is critical to both compliance and success. Learn to recognize areas to assess for gaps in current approaches to CRO selection and oversight related to quality risk management.
Historical, scientific and regulatory information will be reviewed as part of this presentation along with case scenarios to help build a better understanding of the special considerations encountered with clinical research involving children.
Member of the Association for GxP Excellence (AGXPE)? Contact us to learn how you can save 25% on this course. DescriptionWho Should AttendWhat To ExpectDescription COURSE DESCRIPTION OVERVIEW In April 2016, the FDA issued its draft “Data Integrity and Compliance with cGMP Guidance for Industry.” This document quickly followed similar documents issued by other global [...]
Put yourself and your company a step ahead of competitors by understanding the technical skills and regulatory requirements necessary to meet the impending eCTD mandates.
This session which will outline how the new guidance and electronic systems can decrease – or even eliminate – the likelihood of quality gaps seen in the paper approach.
