This 90-minute course will provide you with the tools to understand proper conduct of GLP studies, safeguard against inspection deficiencies, and satisfy regulatory agencies that your efforts are compliant.
Just recently, FDA released two guidances and a draft memorandum describing what manufacturers may do (and may not do) to communicate this information to healthcare providers, consumers, and payors. Learn all about communicating beyond the label in this webinar.
Don’t wait until an FDA inspection to learn there are deficiencies with your approach to drafting and implementing Quality Agreements! This course will provide an overview and discussion of significant portions of the guidance.
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.
This session will provide an overview of the state of FDA guidance on social media with an emphasis on explaining where FDA has provided guidance on compliant use of social media and where FDA has failed to provide guidance.
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.
The focus of this training is to understand how to transform traditional vendor and infrastructure qualification activities and software validation activities into actionable steps for ensuring compliance in the cloud, whether it be with IaaS, Paas, or Saas approach.
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.
This course is designed to provide you with an understanding of the concerns of FDA investigators, the methodologies used by the FDA and the tools necessary to successfully manage these inspections.
This training will underline the meaning of electronic data integrity and how to comply throughout the data lifecycle (i.e., creation to use to archive to deletion). By attending, participants will be able to orchestrate data governance and computer systems validation strategies that position organizations for compliance.
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