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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 110

Validation and Part 11/Annex11 Compliance of Computerized Analytical Systems and Data


Time: 9.00 am to 5.00 p.m.

Fee: US$ 1699


Scheduled Public Seminars

Dates 2015



Jan 19/20


Hotel Orchard Mandarin

Oct 6/7

Zurich, Switzerland


Flexible in-house or public seminars

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

If so, click here


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 2-day 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.

Course objectives

Attendees will:

  1. Learn about the regulatory background and requirements for equipment qualification according to USP <1058>, computer system validation according to GAMP Guides
  2. Learn how to ensure and document integrity of raw data and other records according to Part 11 and Annex 11
  3. Be able to explain the difference between equipment calibration, qualification and system validation
  4. Learn which equipment/systems need to be qualified or validated
  5. Be able to allocate equipment and systems to USP <1058> and GAMP categories and to design and execute qualification/validation protocols accordingly
  6. Understand the logic and principles of instrument qualification and system validation from planning to reporting
  7. Be able to explain your company’s qualification and validation strategies
  8. Understand how to archive raw data from hybrid systems: electronic vs. paper
  9. Be able to define and demonstrate Part 11 compliance functionality to auditors and inspector
  10. Be able to develop inspection ready documentation during on-going routine operation
  11.  Learn how to avoid and/or respond to FDA inspectional observations and warning letters


Session 1

Requirements and approaches for Analytical Instrument Qualification and Computer System Validation

  • FDA/EU, ICH and PIC/S requirements
  •  Lessons from recent FDA Warning Letters and how to avoid them
  • How to motivate managers to allocate resources for Part 11 compliance
  • How to motivate users of equipment and computer systems to comply with Part 11 and other regulations
  • Understanding the terminology: qualification, calibration, verification, validation
  • USP Chapter <1058> for analytical instruments: current and proposed changes
  •  Lessons from GAMP®5 and from the GAMP® guide: “A Risk based Approach to Laboratory Computerized Systems”
  • Which instruments require qualification/validation
  •  Selecting the right validation approach for commercial off-the-shelf systems
  •  Planning for cost-effective qualification and validation

Session 2

Going through the equipment qualification phases

  • The instrument qualification lifecycle
  • Developing a master plan and project plans
  •  Writing requirement specifications
  • Selecting and qualification of suppliers
  •  Documenting installation and installation qualification
  •  Testing for initial operational qualification
  •  Leveraging system suitability testing for on-going performance qualification
  • Preparing and executing test protocols
  •  Preparing inspection ready documentation
  • Documenting evidence of testing and handling deviations

Session 3

Dealing with specific USP <1058> requirements

  • Qualification of firmware
  •  Unplanned and routine maintenance
  •  Change control
  • Time and event based requalification: the importance of risk assessment
  •  Definition and handling of like-for-like changes
  •  Allocating laboratory equipment in one of three USP categories A, B or C
  •  Type and extent of qualification each category
  • Responsibilities of management, users, QA, and suppliers

Session 4

Cost Effective Validation of Laboratory Computer Systems: Step-by-Step

  • Writing a validation project plan
  •  Going through a complete laboratory computer system validation from beginning to end
  •  Setting specifications, vendor assessment, IQ, OQ, PQ, and writing the validation report
  •  How risk assessments can help to determine the type an detail of validation
  •  Integrating the GAMP® guide with USP <1058> for integrated instrument and system validation
  •  Validation of existing systems
  •  Preparing inspection ready validation documentation• Special considerations for IT infrastructure qualification and validation of networked systems
  • Special considerations for IT infrastructure qualification and validation of networked systems

Session 5

Maintaining the validated State of computer systems

  • Ongoing training of users and IT staff
  •  System maintenance
  •  Change control: Handling planned and unplanned changes
  •  How to deal with security patches
  •  Periodic review vs. revalidation of data systems
  •  Criteria for time based revalidation
  •  Disaster recovery and business continuity
  •  Data migration and retirement of computer systems

Session 6

Validation and control of Excel Spreadsheet applications

  • 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
  •  Going through examples
  •  Excel spreadsheet validation from beginning to the end: A case study that can be used by everybody

Session 7

Introduction to FDA 21 CFR Part 11 and EU/PICS Annex 11

  • Objective, scope, current situation and future of Part11
    • Requirements overview and spirit of the regulation
    • Requirements for electronic records
    • Requirements for electronic and digital signature
    • Additional requirements from the PICS/EU Annex 11
    • FDA/EU inspection and enforcement practices of electronic records: examples of recent FDA warning letters and EU inspection reports
    • Define user requirements for Part11/Annex 11 based on risk
    • Upgrading old or purchasing new systems: compliance and business aspects
    • Six steps for risk based implementation of Part 11/Annex 11

Session 8

Ensuring and documenting Integrity of Laboratory (Raw)data and other Records

  • Definition of raw data: FDA/EMA requirements
  •  Defining and documenting ‘complete records
  •  What to archive for hybrid systems: paper records or electronic records
  •  The importance of electronic audit trail to document data integrity
  •  Review of electronic audit trail: who, what, when and how
  •  How to ensure availability of electronic records throughout the entire retention period
  •  The importance of validating security and integrity functions
  •  Examples how to ensure and document data integrity and security
  •  Auditing laboratories for Part 11 and Annex 11 compliance
  • Preparing your organization for FDA and other inspections

®GAMP is a registered trademark of ISPE and stands for Good Automated Manufacturing Practice

The Concept of the Interactive Workshops

  • During the workshop practical examples, case studies and collaborative exercises from laboratories, office applications and manufacturing 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 access to 30+ best practice guides such as instrument qualification and computer validation templates, 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
  • Quality control directors and delegates
  • 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, 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 IVT conferences and has been awarded as the '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

®GAMP is a registered trademark of ISPE and stands for Good Automated Manufacturing Practice