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Validation and Part 11 Compliance of Computer Systems and Data  

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IT/IS managers and system administrators, QA managers and personnel, Laboratory managers and supervisors, Analysts, Validation specialists, Software developers, Regulatory affairs


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Seminar Summary:

Analytical and other equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. (see full course description)


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Training Course Syllabus:

Validation and Part 11 Compliance of Computer Systems and Data

2-Day Workshop by Dr. Huber

Course Description:

Analytical and other 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 not only the text but also the meaning of 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.

Additional Bonus Material for easy implementation (all available as Web download):

70-page primer Analytical Instrument Qualification and System Validation (authored by Dr. Ludwig Huber)
10 SOPs related to validation and qualification of equipment and computer systems, change-control, Risk assessment, maintenance, security and integrity of electronic records
Full Set of Qualification examples for an HPLC system
Full set of Validation examples of a chromatographic Data System

Learning Objectives:
Attendees will:

Learn about the regulatory background and requirements for equipment qualification according to Annex 15, USP <1058>, and computer system validation according to GAMP Guides
Learn how to ensure and document integrity of raw data and other records according to Part 11 and Annex 11
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 avoid and/or respond to FDA inspectional observations and warning letters

Course Outline:
Sessions indicated with (*) include one or more workshop exercises

Day One (8:30 AM - 4:30 PM)

8:30 AM - 9:00 AM: Registration Process

9:00 AM: Session Start

Day 1 – Lectures and Workshop Exercises

Module 1 (*)

Requirements and approaches for Instrument Qualification and Computer System Validation

FDA/EU, ICH and PIC/S requirements
Lessons from recent FDA Warning Letters and how to avoid them
Understanding the terminology: qualification, calibration, verification, validation.
EU/PUCS GMP Annex 15: Validation and Qualification
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”
Planning for cost-effective qualification and validation
Which instruments require qualification/validation

Module 2 (*)

Going through the equipment qualification phases

Develop a project plan from the master plan
Writing requirement specifications
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
Maintenance, requalification and change control

Module 3 (*)

Cost Effective Validation of Computer Systems: Step-by-Step – Part 1

Selecting the right validation lifecycle model
Going through examples of a complete computer system validation from beginning to end
How risk assessments can help to determine the type an extent of validation
Defining user requirements based on risk
Vendor assessment and supplier agreements
Testing and documenting installation
Going through examples for OQ and PQ testing
Writing the validation report

Module 4 (*)

Validation of Computer Systems – Part II

Leveraging validation efforts of identical systems
Validation of existing equipment and computer systems
Preparing inspection ready validation documentation
Integrating the GAMP® guide with USP <1058> for integrated instrument and system validation
Special considerations for IT infrastructure qualification and validation of networked systems
Validation and use of cloud computing in FDA/EU regulated environments
Recommendations for different cloud models and services

Day Two (8:30 AM - 4.30 PM)

Day 2 - Lectures and Workshop Exercises

Module 5 (*)

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

Module 6 (*)

Maintaining the validated State of computer systems or Control of Operation and Retirement

Ongoing training of users and IT staff
System maintenance and data backup
Change control: Handling planned and unplanned changes
How to deal with security patches
Periodic review vs. revalidation
Disaster recovery and business continuity
Retirement of computer systems and data migration

Module 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, and from the UK MHRA and WHO GMP data integrity guidelines
FDA/EU inspection and enforcement practices of electronic records: examples of FDA warning letters reports
User requirements for Part11/Annex 11 based on risk
Upgrading old or purchasing new systems: compliance and business aspects
Six steps for implementation of Part11/Annex 11

Module 8(*)

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

Definition of raw data: FDA/EMA requirements
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, 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 using security
Preparing your company for data integrity audits

Seminar Summary:

Analytical and other equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. (see full course description)

print this agenda print agenda for the Validation and Part 11 Compliance of Computer Systems and Data training seminar

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