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Please note that we need about 3 months preparation for the organisation of your in-house training course.
|08.40 - 09.00||INTRODUCTION|
|09.00 - 10.00||UNDERSTANDING THE REGULATORY REQUIREMENTS OF 21 CFR 11
It is imperative you understand the regulatory requirements for both 21 CFR 11 and the interaction with the applicable predicate rule, otherwise you will have problems implementing an effective approach for Part 11 compliance. Furthermore, the compliance policy guide sets out the FDA's expectations when they inspect a pharmaceutical company. This presentation will explain in detail:
|10.00 - 11.00||LESSONS TO BE LEARNED - 21 CFR 11: CASE HISTORIES
Learn how the regulations are interpreted and enforced by the FDA from actual case studies and what measure should you have in place before you are inspected.
|11.00 - 11.15||Break|
|11.15 - 12.15||21 CFR 11 COMPLIANCE ASSESSMENT AND REMEDIATION PROCESS
To develop a Part 11 compliance assessment and remediation programme you must understand the processes and issues involved. This presentation will explain how to develop a policy that will enable you to become compliant.
|12.15 - 13.15||INTERACTIVE ASSESSMENT OF AN EXCEL SPREADSHEET FOR 21 CFR 11 COMPLIANCE
In order to illustrate 21 CFR 11 compliance, an interactive assessment of an Excel spreadsheet will be demonstrated. This workshop will explain how 21 CFR 11 requirements impact spreadsheets and what features to look for when assessing systems in your organisation
|13.15 - 14.15||Lunch|
|14.15 - 15.15||IMPLEMENTATION AND VALIDATION OF NEW SYSTEMS - 1: REQUIREMENTS, SPECIFICATIONS AND EVALUATION
If you need to replace or update a system what are the benefits you can obtain from 21 CFR 11? Should you replace like with like or redesign to take advantage of the regulation?
|15.15 - 15.30||Break|
|15.30 - 16.30||IMPLEMENTATION AND VALIDATION OF NEW SYSTEMS - 2: QUALIFICATION
Qualification of the system has always been a specific requirement for validation of a system. With the emergence of 21 CFR 11, your system now has to meet the specific requirements for this regulation.
|16.30 - 17.30||WHAT IS THE IMPACT OF PART 11 ON THE INFORMATION TECHNOLOGY DEPARTMENT
Following the Pharmacia warning letters in January 2001, it has become quite apparent that the FDA will be inspecting the IT department to ensure they are compliant with the new 21 CFR 11 regulations. How will your organisation cope with this and what are they doing to ensure compliance within IT? Part 11 extends to the IT Department - but do they know?