Description
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>
01/01/0001
To
01/01/0001
Training Company
The Center for Professional Advancement (CfPA)
Industry
Clinical Research Organization
Course Category
Address
90 Minute Accredited Online Training
90 Minute Accredited Online Training,
