21 CFR Part 11: Strategies for Cost Effective Compliance Using a Risk-based Approach Training Course :

<strong>Course Schedule - Pre-recorded Course</strong><br/><br/>The FDA requires that computer systems involved with the generation, processing, storage or analysis of regulated data conform to 21 CFR Part 11, which provides guidance for system validation; archiving and storage, audit trails, (optional) electronic signatures and data integrity.<br><br> This 90-minute <b><i>accredited</b></i> online training course provides an overview of the requirements of 21 CFR Part 11 and provides a strategy for cost effective compliance.<br><br> <b><u>Module 1:</u> Overview of 21 CFR Part 11</b><br>   • Background of the regulation<br>   • Cost as an access issue<br>     – Components of cost<br>     – Minimizing unnecessary regulatory burdens<br>   • Major Components<br>     – System validation<br>     – Audit Trails<br>     – Archiving<br>     – (Optional) electronic signatures<br>     – Data integrity<br><br> <b><u>Module 2:</u> A Risk Based Approach to Cost Effective Compliance</b><br>   • Risk as the defining characteristic<br>   • A Multi-tier standard<br>   • Low, Medium and High Risk situations<br>     – Full validation<br>     – Data integrity checks<br>     – Audit trails<br>     – Electronic signatures<br>     – Archiving with confirmation<br>     – Basic Validation<br>     – Bare bones validation<br><br> <b><u>Module 3:</u> A Strategy for On-Going Control of Computer Systems</b><br>   • Risk factors<br>     – Frequency; severity<br>   • Steps<br>     – Inventory of systems<br>     – Adoption of multi-tier plan<br>     – Categorization of systems<br>     – Progress toward compliance<br>   • Summary; New developments<br>   • Key issues<br><br> <b>Question and Answer Session</b><br>