Electronic Records and Electronic Signatures (21 CFR Part 11)

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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:
  • Implications of the final rule and how it affects day to day practice - what are the real issues and how to deal with them.
  • Electronic records and closed systems defined and what they mean
  • Electronic records and their management and how 21 CFR 11 will affect:
    • Open and closed systems
    • Security and access control issues
    • The use of hybrid systems (paper signatures and electronic records) ? What systems create electronic records and are governed by 21 CFR11?
  • Is validation of all systems and documentation required? If so, how can the data be collected and presented effectively
  • The real impact of 21 CFR 11 on electronic signatures, digital signatures, and record and signature linking
  • Enforcement update from the FDA: Compliance Policy Guide - You must comply!!
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.
  • Case studies of real examples of Establishment Inspection Reports, Warning Letters and Inspectional Observations (Form 483) e.g.. Gaines Chemical Company 483 observations in December 1999. Linweld warning letter August 1999 and its consequences. Plus examples of other companies....
  • Key learning points from inspections involving 21 CFR 11 and the safeguards that you need to implement.
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.
  • Why you need a policy for 21 CFR 11 compliance: contents and coverage
  • Checklist for assessing how your project is progressing
  • Setting up an inventory for all computerized systems and risk assessment for each system.
  • Gap and Plan Approach - what it is, and how to use it effectively to assess if your systems are compliant
  • Evaluating each system against validation and electronic records/electronic signature (ER/ES) requirements (Gap) with real examples of non-compliance
  • Making sure your administrative and procedural controls are in place (Gap)
  • Planning to make your system compliant (Plan for Remediation)
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
  • Compliance assessment of an Excel spreadsheet
  • Discuss possible procedural and technical solutions
  • Outline the limitations of this approach and potential differences with larger systems
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?
  • Look at your process and computer validation requirements: can you improve the process and gain benefits from working electronically as well as reducing your validation workload?
  • What are the specification needs and the possible problems associated with:
    • The system requirements
    • Electronic records/electronic signature (ER/ES) requirements
  • How to evaluate the new system/application
    • Electronic Records and Electronic Signatures (21 CFR 11) Requirements
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.
  • What the Qualification definitions are and who and what they refer to:
    • Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)
  • Is there a 'real' need for IQ and OQ review of vendor supplied material?
  • Designing a PQ (end user testing) specifically for electronic records and signatures - including backup and recovery/archive and restore mechanisms.
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?
  • Necessity of communicating with all departments before making changes that impact the validation status of user applications
  • Is your organization's network qualified?
  • Are there procedures in place to cover IT operations?
  • What types of electronic records are generated in normal IT operations, and are the IT systems you use to generate electronic records validated?
  • Impact of the Pharmacia warning letters on outsourcing IT operations
  • Understanding the IT problems and the practical solutions

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