Analytical equipment should be qualified, and computer systems should be validated to demonstrate suitability for their intended use. To be acceptable to regulatory authorities, electronic records must comply with 21 CFR Part 11, Annex 11 to EU GMPs, and more recent data integrity guidance. Recent EU and FDA reports demonstrate that qualification, validation, and electronic records are priority areas for inspection. A large number of FDA warning letters and the frequency of EU enforcement action in these areas demonstrate that companies sometimes struggle to understand or implement the regulations.

This 2-day course guides attendees through equipment qualification, calibration, and computer system validation processes from planning to reporting. It also explains regulatory requirements in these areas, including EU and US GMPs, as well as data integrity guidance documents from national and international regulatory bodies.

The course not only ensures a full understanding of the regulations and guidelines for equipment and records but helps attendees to develop a risk-based approach to compliance. Interactive exercises will be dispersed into and between the presentations.

Learning Objectives:-

• Learn about the regulatory background and requirements for equipment qualification according to USP <1058> and computer system validation according to GAMP 5
• Be able to explain the difference between equipment calibration, qualification, and system validation
• Learn which equipment/systems need to be qualified or validated
• Be able to allocate equipment and systems to USP <1058> and GAMP 5 categories and to design and execute qualification/validation protocols accordingly
• Understand the logic and principles of instrument qualification and system validation from planning to reporting
• Be able to develop a qualification and validation strategy
• Understand how to archive raw data from hybrid systems: electronic vs. paper
• Be able to define and demonstrate regulatory compliance to auditors and inspectors
• Be able to develop inspection ready documentation
• Learn how to ensure, document, and audit the integrity of GMP records

DAY 01(10:00 AM - 5:00 PM EST)

• 10.00 AM - 10.45 AM - Requirements and approaches for Analytical Instrument Qualification
  • FDA/EU, PIC/S requirements
  • Qualification/calibration issues in FDA inspections
  • USP General Chapter <1058>: Analytical Instrument Qualification
  • The instrument qualification lifecycle
  • Prioritizing calibration/qualification activities
• 10.45 AM - 11.30 AM - Qualification in Practice
  • User requirement specifications
  • Installation qualification
  • Operational qualification
  • Preparing inspection-ready documentation
• 11:30 AM - 11:45 AM - Break
• 11.45 AM - 12.45 PM - Testing and deviation handling
  • Developing test protocols
  • Documenting test evidence
  • Review and approval of test results
  • Handling deviations
• 12:45 PM - 1:15 PM - Break
• 1.15 PM - 2.30 PM - Retrospective qualification and Requalification
  • Qualification of existing systems
  • Leveraging experience
  • Time-based requalification
  • Event-based requalification
  • What and how much to test – a risk-based approach
• 2.30 PM - 3.15 PM - Equipment Maintenance and Change control
  • Preventive maintenance; tasks, documentation
  • Planned and unplanned changes
  • Changing hardware, firmware, documentation
  • Definition and handling of like-for-like changes.
  • Handling changes made by vendors
• 3.15 PM - 4.00 PM: Type and extend of qualification for USP Instrument Categories
  • The approach and benefits of instrument categories
  • How to identify the correct category: A, B, C
  • Type and extent of qualification for each category
  • Required procedures and qualification deliverables
  • Responsibilities for instrument qualification
• 4:00 PM - 4:15 PM - Break
• 4.15 PM - 5.00 PM - Requirements and approaches for GMP Computer Systems
  • 21 CFR Part 211, Part 11, PIC/S, EU Annex 11
  • Most critical inspection findings
  • Which systems need to be validated
  • GAMP 5: A Risk-based Approach to Laboratory Computerized Systems
  • Examples for risk assessment of computer systems
• Validation of Laboratory Computer systems
  • Writing a validation project plan
  • Integrating GAMP 5 with USP <1058> for instrument and computer system validation
  • Writing a validation report

DAY 02(10:00 AM - 5:00 PM EST)

• 10.00 AM - 10.15 AM - Questions and answers from Day 1
• 10.15 AM - 11.00 AM - Validation and Use of Excel in the QC Laboratory
  • Designing spreadsheets for compliance
  • Validation approach for spreadsheets – single and multiple-use spreadsheets
  • When what and how much to test?
  • GAMP 5 recommendations
  • How to ensure spreadsheet data integrity
• 11:00 AM - 11:15 AM - Break
• 11.15 AM – 12.15 PM - Configuration management and change control
  • The IEEE standard for configuration management
  • The change control process for planned changes
  • Unplanned changes
  • Upgrading software
  • What to test after changes
  • How to document changes
• 12.15 PM – 1.00 PM - Periodic revalidation of chromatography data systems
  • The approach and practice of periodic review
  • Using periodic review to reduce the frequency of revalidation
  • Criteria for time-based revalidation
  • Incidents requiring revalidation
  • Validation tasks after installing security and other patches
• 1:00 PM - 1:45 PM - Break
• 1.45 PM - 2.30 PM - Handling raw data and other laboratory records
  • Definition of raw data: electronic vs. paper
  • Acquisition and recording of raw data
  • How to make accurate and complete copies of raw data
  • Changing records
  • Archiving of raw data and ready retrieval
• 2.30 PM - 3.00 PM - Ensuring Integrity and Security of GMP data
  • Most frequent security and integrity issues
  • The importance of electronic audit trails
  • Review of electronic audit trails: who, what, when, and how
• 3:00 PM - 3:15 PM - Break
• 3:15 PM - 4.30 PM - Auditing Laboratory Computer Systems
  • Using FDA inspection practice
  • Importance of data governance policy and controls
  • Preparing inspection-ready documentation
  • Responding to typical inspectional/audit observations
• 4.30 PM - 5.00 PM - Wrap up - Final questions and answers

Who Should Attend:-

• IT/IS managers and system administrators
• QA managers and personnel
• Laboratory managers and supervisors
• Analysts
• Validation specialists
• Software developers
• Regulatory affairs
• Training departments
• Documentation departments
• Consultants