Conference Description:

With new guidelines and requirements in place the focus of both FDA and international inspections is shifting shift more and more to computer systems and Electronic records. An example is the new EU Annex 11 with requirements for periodic evaluation, vendor agreements, incident management and structured back-up. Just in the last three years more than 30 warning letters mentioned violations for computer systems, some of them with disastrous consequences for the companies.

Reference material for easy implementation:

-SOP Auditing Computer Systems
-Part 11 checklist
-Checklis

Areas Covered in the Session :

>. FDA regulations and guidelines
10 most frequently found deviations and how to avoid them
>. Developing an SOP for audits of computer systems.
>. Effective development and use of audit checklists
>. Conducting the audit: review procedures, walk through the computer system area
>. Most critical computer system questions to ask: traditional and new ones
>. Auditing for data integrity
>. Documenting detailed audit findings
>. The audit summary report

Who Should Attend:

>. IT Departments
>. QA Departments
>. Operations Departments
>. Users of computer systems in regulated areas
>. Analysts and lab managers
>. Validation specialists
>. Training Departments
>. Documentation Departments
>. Consultants