| 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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