ComplianceOnline

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.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

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
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 5:00 PM)
  • 8:30 – 9:00 AM: Registration
  • 9:00 AM: Session Start Time
  • 09.00 - 09.45: Requirements and approaches for Analytical Instrument Qualification
    • FDA/EU, PIC/S requirements
    • Qualification/calibration issues in FDA inspections
    • USP Chapter <1058>: current and proposed changes
    • The instrument qualification lifecycle
    • Planning for cost-effective calibration/qualification
  • 09.45 - 10.30 (*): Going through the qualification phases
    • Writing requirement specifications
    • Installation and installation qualification
    • Testing for initial operational qualification
    • Leveraging system suitability testing for on-going performance qualification
    • Preparing inspection ready documentation
  • 10:30 - 11:00: Break
  • 11.00 - 11.45 (*): Testing and deviation handling
    • Developing generic test protocols
    • Documenting test evidence
    • Going through an example test protocol
    • Review and approval of test results
    • Handling deviations
  • 11.45 - 12.30: Retrospective qualification and Requalification
    • Qualification of existing systems
    • Leveraging past experience
    • Time based requalification
    • Event based requalification
    • What and how much to test
  • 12:30 - 13:30: Lunch
  • 13.30 - 14.15 (*): 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
  • 14.15 -15.00 (*): 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
  • 15:00 - 15:30: Break
  • 15.30 - 16.15 (*): Requirements and approaches for Laboratory Computer Systems
    • FDA Part 211, Part 11, PIC/S Annex 11
    • Most critical inspection findings
    • Which systems need to be validated
    • Learning from the new GAMP® guide: “A Risk based Approach to Laboratory Computerized Systems”
    • Examples for risk assessment of computer systems
  • 16.15 - 17.00 (*): Validation of Laboratory Computer systems
    • Writing a validation project plan
    • Going through a complete laboratory computer system validation from beginning to end
    • Integrating the GAMP® guide with USP <1058> for integrated instrument and system validation
    • Writing a validation report as a mirror to the plan
    • Preparing inspection ready validation documentation
Day 02(8:30 AM - 4:30 PM)
  • 08.30 - 09.00: Review of day
    • Questions and answers from Day 1
    • Main conclusions and action items
  • 09.00 - 10.00 (*): Validation and Use of Excel in the QC Laboratory
    • Designing spreadsheets for compliance
    • Validation approach for spreadsheet applications
    • When, what and how much to test?
    • Recommendations from GAMP®5 for testing native Excel functions
    • How to ensure spreadsheet and data integrity
  • 10:00 - 10:30: Break
  • 10.30 - 11.15 (*): Configuration management and Change control
    • The IEEE model for configuration management and change control
    • The change control process for planned and unplanned changes
    • Versioning of software and computer systems
    • What to test after changes
    • How to document changes
  • 11.15 - 12.00 (*): Periodic review and revalidation of chromatographic data system
    • The approach and practice of periodic review
    • Using periodic review to reduce frequency of revalidation
    • Criteria for time based revalidation
    • Incident requiring revalidation
    • Validation tasks after installing security and other patches
  • 12:00 - 13:00: Lunch
  • 13.00 - 13.45 (*): 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 of data and other records
    • Archiving of raw data and ready retrieval
  • 13.45 - 14.30: Ensuring Integrity and Security of Laboratory (Raw) data
    • Most frequent security and integrity issues: going through recent 483's, EIRs and warning letters
    • The importance of electronic audit trail to document data integrity
    • Review of electronic audit trail: who, what, when and how
    • Examples how to ensure and document data integrity
  • 14:30 - 15:00: Break
  • 15:00 - 16.15 (*): Auditing Laboratory Computer Systems and records for FDA Compliance
    • Using FDA Inspections as model for laboratory audits
    • Going through a typical FDA computer system inspection
    • Preparing inspection ready documentation
    • Responding to typical inspectional/audit deviations
    • Learn how to avoid or respond to FDA 483s and warning letters
  • 16.15 - 16.30: Wrap up – Final questions and answers
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Dr. Ludwig Huber

Dr. Ludwig Huber
Director and Chief Editor, LabCompliance

Dr. Ludwig Huber is Director and Chief Editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories . Mr. Huber is an expert for FDA and equivalent international compliance and for ISO/IEC 17025 laboratory accreditation. He is also the Chairman, presenter and panel discussion member at US-FDA industry training sessions and conferences.

He served as a team member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP® special interest group on laboratory equipment. In addition, he was awarded as Presenter of the Year of the Institute for Validation and Technology. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press.

For more information, visit www.ludwig-huber.com

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Seminar One Registration

September 14-15, 2017, Boston, MA
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September 14-15, 2017, Boston, MA

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Location

Courtyard Boston Cambridge
777 Memorial Drive,
Cambridge, MA, 02139, United States
Tel: 617-492-7777

September 14-15, 2017

Special Offer

Special Offer for the attendees of this seminar

Rooms available at only $329 per night.

You must book by August 11th @ 9am EST, 2017.

Book your group rate for COMPLIANCE ONLINE

Please note: Hotel rooms are limited and based on availability.

How to Reach

General Driving Directions:

From Boston Logan International Airport – BOS: 7.3 mile(s) W:
  • Exit Airport and take MassPike (I-90) West to Exit 20 (Cambridge)
  • Continue straight and cross bridge
  • Take first right after bridge onto Memorial Drive
  • Hotel is 200 yards ahead on the left.
From Manchester-Boston Regional Airport – MHT: 55.1 mile(s) SE
  • Follow I-293 to I-93S towards Boston
  • Take exit 26B (Storrow Drive West) and continue for 3 miles
  • Bear right at the Central Square/MassPike exit and turn right at the light
  • After crossing the bridge, take first right onto Memorial Drive and Hotel is on the left.
From T F Green Airport – PVD: 62.1 mile(s) NE
  • Take I95N to I93N
  • Then, take exit 26 (Storrow Drive West) and follow Storrow Drive
  • Take the Central Square/MassPike exit and turn right at light
  • After crossing the bridge, take first right onto Memorial Drive and Hotel is on the left.

Other Transportation:

Bus Station
  • South Station: 5 mile(s) SE
Subway Station
  • B.U. Central (on the Green Line): 0.8 mile(s) SE
  • Central Station (on the Red Line): 0.8 mile(s) NE
Train Station
  • Back Bay Station (BBY): 3 mile(s) SE
  • South Station (BOS): 5 mile(s) SE

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.

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Local Attractions of Boston, MA

Boston Public Garden

Boston Public Garden

This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.

Boston Public Library

Boston Public Library

The Boston Public Library was the first large municipally-funded public library in America. It has a central location right in the heart of Copley Square, facing the Trinity Church, easily accessible by taking the Green Line to Copley station (or also near to Orange Line Back Bay stop).

Fenway Park

Fenway Park

Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right in downtown Boston - so it is very accessible if you are visiting the area.

Museum of Fine Arts

Museum of Fine Arts

Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyptian collections and early American art.

Museum of Science

Museum of Science

The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space travel to wildlife to physics to human biology to an in-depth look at Boston's "Big Dig" project.

North End

North End

This Italian neighborhood, Boston's oldest, is known for its wonderful restaurants and historic sights.

Old North Church

Old North Church

The signal from the steeple of Boston's oldest church triggered the War for Independence that led to the birth of America. On that fateful night in 1775, the two lanterns in the steeple told Paul Revere that the British were approaching by boat, not on foot.

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