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Learn from FDA Warning Letters what inspectors look for and what mistakes other companies make so you can avoid them

 

Compliance Workshop

Learn through case studies and direct interaction with pears and the speaker.

Compliance Workshop 112

Analytical Instrument Qualification and System Validation

 

Time: 9.00 am to 5.00 p.m.

Fee: US$ 1699

 

Scheduled Public Seminars

Dates 2015

Location

Venu

April 13/14

San Diego, CA

TBA

July 27/28

Philadelphia, PA

TBA

Flexible in-house or public seminars

Interested in organizing any in-house or public seminar: at any time, anywhere?

If so, click here

 

Overview

Analytical instruments should be qualified and systems should be validated to demonstrate suitability for the intended use. This two day in-person seminar will provide attendees the regulatory background and guidance through the complete process from planning and writing requirement specifications to vendor assessment, installation and operational qualification and ongoing testing during routine use. This interactive workshop will help attendees understand the instrument qualification and system validation processes and will provide templates and examples to develop inspection ready documentation.

Practical examples and interactive exercises will be dispersed into and between the presentations while 50% of the total time will be dedicated to practical sessions. During the seminar, attendees will 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 from the course.Course objectives

Attendees will:

  1. Learn about the regulatory background and requirements for laboratory instrument qualification and system validation
  2. Understand the logic and principles of instrument qualification and system validation from validation planning to reporting
  3. Understand and be able to explain your company’s qualification and validation strategies
  4. Be able to independently prepare and execute test protocols, this includes setting specifications and acceptance criteria
  5. Understand how to review and approve qualification and validation protocols
  6. Be able to develop inspection ready qualification and validation deliverables
  7. Learn how to avoid and/or respond to FDA inspectional observations and warning letters

Course Outline Day 1

Session 1: 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

Session 2: 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

Session 3: 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

Session 4: Retrospective qualification and & requalification

  • Qualification of existing systems
  •  Leveraging past experience
  • Time based requalification
  • Event based requalification
  • What and how much to test

Session 5: 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

Session 6: 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

Session 7. 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

Session 8. 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

Course Outline Day 2

Session 9: Retrospective qualification of equipment and validation of computer systems

  • FDA requirements and enforcement
  • Approaches for existing systems vs. new system validation
  • Documenting system use
  • Leveraging past experience
  • What and how much to test
  • Maintaining the validated state

Session 10: Validation and Use of Excel in the QC Laboratory

  • FDA expectations for control and validation of spreadsheets
  • 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
  • Case study: Going from beginning to the end
  • How to ensure spreadsheet and data integrity
  • Dealing with audit trail requirements
  • Learning from FDA spreadsheet Laboratory Information Bulletins (LIBs)

Session 11: Periodic review and revalidation of chromatographic data system

  • Regulatory requirements
  • The approach and practice of periodic review
  • Periodic review as cost-effective alternative for time-based revalidation
  • Documentation of the review
  • Criteria for time based revalidation
  • Incidents requiring revalidation
  • Re-validation tasks after hardware, firmware and software

Session 12: Network qualification, change control of computer systems

  • Qualification of infrastructure overview
  • Planning and design qualification
  • Installation and IQ
  • Initial and on-going testing
  • Maintaining the validated state
  • Change control: procedures for planned and unplanned
  • Cloud computing

Session 13: Handling raw data and other laboratory records

  •  Definition of raw data: electronic vs. paper
  • Definition of complete, regulated records
  • 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: paper vs. electronic archiving

Session 14: 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
  • Recommendations to ensure, defend and document data integrity
  • Demonstrating integrity through system drawing – step-by-step

Session 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

The Concept of the Interactive Workshops

  • During the workshop practical examples, case studies and collaborative exercises will be dispersed into and between the presentations. At least 50% will be dedicated to practical sessions with life examples. The outcome will be made available for all attendees on a special workshop reference website.
  • After the workshop attendees will have web access to 30+ best practice guides such as master plans, examples, checklists and SOPs. This will enable attendees to easily implement what they have learned 

Who will benefit from the course

By function

  • 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

By industry and organizations

  • Pharmaceutical development and quality control
  • Biopharmaceutical development and quality control
  • API manufacturing
  • Medical device development and manufacturing
  • Clinical research organizations
  • Contract laboratories
  • Equipment suppliers and service providers supporting related organizations

What attendees get

  •  Workshop conducted by an internationally recognized compliance expert
  • Industry proven real-life case studies
  • Highly efficient workshop exercises through prefilled templates
  •  Answers to any issues directly by the trainer in an one-on-one interaction
  • Take home SOPs, templates and examples for cost effective implementation
  • Access to the PowerPoint presentations to train others in your company
  • 30 days phone and e-mail post workshop support through the trainer
  • Certificate of training completion
  • Detailed documentation of the trainer's qualification

More info?

If you are interested in this In-house workshop or in organizing it as public workshop, please click here.

About the speaker: Dr. Ludwig Huber

  • Chairman, presenter and panel discussion member at US-FDA Industry training sessions and conferences
  • Team and/or review member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP special interest group on Laboratory Systems
  • Presenter of the Year of the Institute for Validation and Technology selected out of 170 presenters
  • Author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press
  • Director and chief editor of www.labcompliance.com, the global on-line resource for validation and compliance issues.
  • For more information on Ludwig Huber, click here.
Dr. Ludwig Huber is a frequent presenter at  conferences and has been awarded as IVT's 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

 Free best practice guides for Analytical Instrument Qualification

  • 70-page primer: Analytical Instrument Qualification and System Validation (authored by Dr. Ludwig Huber
  •  Full set of Validation examples of a chromatographic Data System
  • SOP: Analytical Instrument Qualification according to USP  <1058>
  • SOP: Allocating Analytical Instruments to USP <1058> categories
  • SOP: Procedures and deliverables for USP <1058> categories
  • SOP: Qualification of Analytical Balances
  • SOP: Qualification of Refrigerators
  • SOP: User Requirement Specifications (URS) for Analytical Equipment
  • SOP: Change Control for Analytical Equipment
  • SOP: Development and maintenance of test scripts for analytical systems
  • SOP: Requalification of Analytical equipment
  • Master plan: Equipment qualification
  • Example: HPLC Validation Plan
  • Example: HPLC Requirement Specifications
  • Example: HPLC Design Qualification
  • Example: HPLC Installation Qualification
  •  Example: HPLC Operational Qualification
  • Example: HPLC Performance Qualification
  • Example: HPLC: Summary Report
  • Reference Paper: Equipment Qualification in Practice
  • Reference Paper: Selecting Parameters and Limits for Operational Qualification
  • Qualification conditions, frequency of requalification and acceptance limits for 20 laboratory instruments

Free best practice guides for Laboratory Computer Validation

  • SOP: Validation of Laboratory Computer Systems
  • SOP: Periodic Evaluation and Review of Computerized Systems
  • SOP: Revalidation of Software and Computer Systems
  • SOP: Risk Based Qualification of Network Infrastructure
  • SOP: Auditing Computer Systems
  • SOP: Validation of Spreadsheet Applications
  • SOP: Development und use of Spreadsheet Applications
  • Gap analysis: Laboratory computers systems
  • Template/Examples CDS Validation from Beginning to the End - Step-by-Step
  • Template/Examples CDS Project plan
  • Template/Examples CDS Requirement specifications
  • Template/Examples CDS Vendor qualification
  •  Template/Examples CDS Installation qualification
  • Template/Examples CDS Operational qualification
  • Template/Examples CDS Performance qualification
  • Template/Examples CDS Test plan
  • Template/Examples CDS Validation report

Free best practice guides for Part 11/Annex 11 - Data integrity

  • SOP: Integrity and Security of Electronic Laboratory Data
  • SOP: Electronic Audit Trail - Specification, Implementation, Validation
  • SOP: Review of Electronic Audit Trail
  • SOP: Define Scope and Controls for Part 11
  • SOP: Manual chromatographic reintegration
  • Case Studies: Part 11 Implementation
  • Checklist: Security and Integrity of Electronic Data in Laboratories
  • Checklist: Electronic Audit Trail
  • 10 Case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions
  • Retention and Archiving of Electronic Records
  • Checklist: FDA Record Retention and Retrieval
  • Regulatory reference document:
    Drug cGMP Requirements for Laboratory Records
  • Regulatory reference document:
    FDA GCP Regulations: Requirements for Clinical Trial Records
  • FDA Presentation: Edwin Rivera: Data Integrity and Fraud – Another Looming Crisis?
  • FDA Presentation:  Steve Wilson FDA Regulatory Perspective an Data integrity
  • Warning letters and Inspectional observations related to laboratory data integrity and security
  • Literature Reference Papers.
    - Implementing 21 CFR Part 11 - Data Migration and Long Term Archiving for Ready Retrieval
  • Warning letters and Inspectional observations related to electronic raw data and other electronic records.
  • FDA guidance documents and predicate rules

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