Validating Computerised Analytical Equipment and Systems

  Content 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 system
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
  Content 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

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