2-Day Virtual Seminar Analytical Instrument Qualification and System Validation


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Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory are records are on target of inspectors. The large number of warning letters issued to laboratories also demonstrate that they struggle with either understanding or implementing the regulations.

This 2-day course provides the regulatory background and guides attendees through the complete equipment qualification, calibration and computer system validation processes from planning to reporting. It also helps to fully understand Part 11 and Annex 11 requirements to ensure and document integrity and other requirements for electronic records and signatures.

The course not only ensures a full understanding of the regulations and guidelines for equipment and records but also provides templates and examples to develop inspection ready documentation. Interactive exercises will be dispersed into and between the presentations. About 50% of the total time will be dedicated to practical sessions. Here attendees work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned in the course.

Learning Objectives:

Attendees will:

  • Learn about the regulatory background and requirements for equipment qualification according to USP <1058> and computer system validation according to GAMP Guides
  • 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 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 explain your company’s qualification and validation strategies
  • Understand how to archive raw data from hybrid systems: electronic vs. paper
  • Be able to define and demonstrate Part 11 compliance functionality to auditors and inspectors
  • Be able to develop inspection ready documentation during on-going routine operation
  • Learn how to ensure, document and audit integrity of raw data and other records

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

Companies and departments

  • Pharmaceutical development and Quality control laboratories
  • Quality control laboratories of API manufacturers
  • Contract laboratories
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 a 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 - 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
Seminar (Price/Register)
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

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Speaker: Dr. Ludwig Huber, Director and Chief Editor, LabCompliance

Dr. Ludwig Huber, Ph.D., is the director of Labcompliance and editor of www.labcompliance.com, the global online resource for validation and compliance. Dr. Huber is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems". He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies.


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