Possible Topics to be Covered:

Introduction

• Presenter and participants introduce themselves
• List participant learning objectives
• Overview of the course

Why Validate?

• Want to validate versus must validate approaches
• Cost of compliance versus of non-compliance
• Benefits of validation: delivering a system meeting user requirements

Key Terms and Definitions

• Define words etc
• Problems with equipment qualification
• Introduction to FDA glossary on computerised system validation

The Regulations

• Scope of regulations and guidelines impacting computerised systems
• Historical background to regulations on computerised systems in the pharmaceutical industry
• Overview of regulations and guidelines for GCP and GLP

Workshop

• Compare and contrast the two regulations or guidelines for computerised system validation relevant to the client’s area.

Regulations and Guidelines

• GAMP 3: approaches to validation of systems
• OECD GLP: minimum list of SOPs and an inspectors approach
• Boehm (1970) why complete validation of a system is a myth

Workshop

• Review FDA Warning letters from GLP, GMP and medical device GMP
• Derive common problem areas with computerised systems

System Development Life Cycle

• Overview of SDLC: ISO V model and waterfall model
• Designing Quality validation and verification
• Documented evidence
• ISO 9000-3 (ISO 12207) and Tick-IT quality schemes for software
• What the FDA think of ISO 9000-3

Vendor Audits

• Rationale for vendor audits
• How to carry out vendor audits
• Evidence of system development life cycle activities
• Reporting the results
• Vendor management programmes

Medical Device Regulations

• Discussion on 21 CFR 820: cGMPs for medical devices (Quality System Regulation) for software
• CDRH draft guideline on General Principles of Software Validation

Workshop

• Review General Principles of Software Validation
• Incorporate key requirements in an updated SOP

Revalidation: All or Part of the System?

• Revalidation Policy
• Impact of changes on revalidation: partial, no or full revalidation?

Electronic Signatures and Electronic Records: 21 CFR 11

• Outline of the key points of the legislation
• Publication of enforcement policy 30th July 1999
• Open and closed systems and other definitions
• Trustworthiness of records: the need for an audit trail
• Digital signatures and biometrics
• Legacy systems and electronic records: no grandfathering of systems
• Impact on manufacturing R&D systems

Workshop on Electronic Signatures and Electronic Records

• Review the final regulation and derive regulatory requirements

Keeping a System Validated when Operational

• Change Control and Configuration Management
• Backups, Recovery, Archive and Restore
• Disaster Recovery
• Maintenance of the system

So You Think You are Compliant?

• Real world IT (Information Technology) Departments
• Impact of IT on the compliance status of Regulated systems
• Outsourced operations and service level agreements (SLA)
• Compliance and IT departments: impact of electronic records regulations

Workshop

• Update the audit checklist with points from the operational and IT discussions
• Review whole checklist

System Retirement and Data Migration

• Issues covering system retirement
• Data migration considerations

Review of the Course

• Discussion of participant learning objectives
• Discuss issues arising
• Close of course