Validating Computerised Analytical Equipment and Systems

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Please note that we need about 3 months preparation for the organisation of your in-house training course.

	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