“The Compliance Certification Board (CCB)® has approved this event for up to 13.8 live CCB CEUs. Continuing Education Units are awarded based on individual attendance records. Granting of prior approval in no way constitutes endorsement by CCB of this event content or of the event sponsor.”
Mark Powell
Director, Mark Powell Scientific Limited
Course Description
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. The 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
Agenda
DAY 01(10:00 AM - 5:00 PM EDT)
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 - Lunch
1.15 PM - 2.30 PM - Retrospective qualification and Requalification
- Qualification of existing systems
- Leveraging past experience
- Time-based requalification
- Event-based requalification
- What and how much to test – 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 EDT)
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 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 - Lunch
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 will Benefit
- 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
In Partneship With Compliance Online
Mark Powell
Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development. During this time, he was responsible for method validation, verification and transfer activities, as well as the qualification of laboratory instruments and computerized data systems.