| When |
What |
| Day
1 |
|
| 08.40 - 09.00 |
INTRODUCTION |
| 09.00 - 10.00 |
INTRODUCTION TO
COMPUTERISED SYSTEM VALIDATION
- Key terms and definitions
- Problems with qualification
terminology: defining what you really mean
- Global regulatory overview of
GLP and GMP for computerised systems
- System development life cycle
and documented evidence
|
| 10.00 - 11.00 |
OVERVIEW OF
ELECTRONIC RECORDS AND ELECTRONIC SIGNATURES FOR LABORATORY SYSTEMS
- Key points of the regulation
- Step change in validation
requirements
- Compliance Policy Guide
requirements
- Standalone or networked
applications and systems?
- Case studies from warning
letters and 483 observations
|
| 11.00 11.15 |
Break |
| 11.15 - 12.15 |
SYSTEM REQUIREMENTS
SPECIFICATIONS
- Importance of the SRS
- How to write requirements
- Traceability of requirements
- Practical example for a
chromatography data syste
|
| 12.15
- 13.15 |
Lunch
|
| 13.15 - 14.15 |
OVERVIEW OF GUIDES TO
HELP VALIDATION
- GAMP Guide: what is it, features
available for validation
- PDA Technical Guides 18 and 31
- IEEE standards for documentation
Web sites for validation help |
| 14.15 - 15.15 |
Break |
| 15.15 - 15.30 |
APPROACHES TO
VALIDATION RISK MANAGEMENT
- GAMP Guide validation strategy
for laboratory systems
- SQA Questionnaire to classify a
system
- Appliance of science
|
| 15.30 - 16.30 |
CASE STUDY:
RETROSPECTIVE VALIDATION OF A CHROMATOGRAPHY DATA SYSTEM
- Gap and Plan approach
- Assessment of documented
evidence
- Filling the gaps
|
| Day 2 |
|
| 08.30 - 09.30 |
POLICIES AND
PROCEDURES REQUIRED FOR 21 CFR 11 COMPLIANCE
- Policies and administrative
controls required for 21 CFR 11
- Roles and responsibilities
within the organisation
- Procedures for 21 CFR 11
compliance
|
| 09.30 - 10.30 |
REVIEW OF VENDORS
QUALIFICATION MATERIAL ESPECIALLY FOR 21 CFR 11 COMPLIANCE
- Can you save validation effort
by using vendor material?
- Why is it important to review
vendor's qualification material?
- Comparing your requirements to
the qualification package and assessing the gaps
- Fill the gaps or carry the
regulatory risk?
|
| 10.30 - 10.45 |
Break
|
| 10.45 - 11.45 |
CASE STUDIES OF
VALIDATING LABORATORY SYSTEMS AND DISCUSSION OF DELEGATES ISSUES
- Laboratory Information
Management Systems (LIMS)
- Mass spectrometer data system
- Automated dissolution system
- Biotechnology instruments
- Spreadsheets
- Delegates bring their validation
issues for discussion among the course
|
| 11.45 - 12.45 |
LEGACY SYSTEMS AND
DATA MIGRATION
- Legacy systems and their
problems
- 21 CFR 11 requirements for ready
retrieval of data
- Case study of data migration
|
| 12.45 - 13.45 |
Lunch
|
| 13.45 - 14.45 |
AUTOMATED TESTING:
ELECTRONIC NIRVANA?
- Automated testing: advantages,
benefits and disadvantages
- When to consider automated test
tools
- How to use automated test tools
|
| 14.45 - 15.45 |
MAINTAINING THE
VALIDATION OF YOUR SYSTEMS
- Change control and configuration
management
- Protecting your electronic
records: Backup and recovery, Archive and retrieve
- Involving the IT department for
networked applications
|
| 15.45 - 16.15 |
REVIEW OF THE COURSE
- Revisit participant objectives
- General discussion
|
