The focus of this training is to review, compare, and contrast currently available draft and final guidance documents in order to understand the various agencies’ current thinking on data integrity and how it impacts the GxP-regulated industry. The outcome will be the delivery of data governance strategies that position organizations for compliance.
This course will address the implementation logistics of the questions answered by the FDA in the guidance, to allow you to develop an implementation plan for the short and long term. Come to this session to learn how to take the FDA recommendations into specific industry settings including sites, sponsors and IRBs.
This webinar will provide direction and information on the second Cyber Security guidance entitled “Postmarket Management of Cybersecurity in Medical Devices” issued by the US FDA in December 2016, helping you make sense of the terminology and align the technical guidance to business risk in your program.
In this course, we will examine the “why” behind the mandate and how it can change the way therapies are being developed, leading to faster market delivery of better drugs. We will explore FDA’s vision of having electronic access to all submission data in ways that are not currently feasible. The electronic standards for exchange of nonclinical data (SEND) and clinical data (SDTM), developed by CDISC, will be discussed, focusing on SEND.
This course addresses the 2016 implementation of FDA’s and CBP’s new entry information program — the Automated Commercial Environment (ACE) — which applies to the initial importer, the customs broker, and the foreign firm associated with an imported product’s entry into the U.S. Importers and brokers currently struggle to use the correct FDA information codes, and failure to do so may cause the entry to be detained and monetary fines.
Risk-Based Monitoring (RBM) is changing the way companies are conducting clinical trials. Adopting RBM requires changes to a company’s processes and tools for monitoring. Building a quality risk management program and implementing technology will be critical in strategies to increase quality and efficiency and deliver accurate analyses of clinical study site performance and data quality.
This course will provide an overview of the 21 CFR Part 11 Electronic Record and Electronic Signature (ERES) requirements and the current compliance landscape for IT systems.
Based on a wealth of real-life experience and laced with real-life examples, this course builds on Good Automated Manufacturing Practices mandates to define practical steps for a risk-based approach to validation.
This course will focus on the current top five FDA regulatory enforcement trends relevant to computerized systems compliance, validation, and data integrity.
This course will focus on the current top five FDA regulatory trends, warning letters and enforcement actions related to Computer Systems Validation (CSV).
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.
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 [...]
