New York Professional Events List

Validation and Part 11 Compliance of Computer Systems and Data

Jul 12, 2017 - 09:00 AM - Jul 13, 06:00 PM
Global Compliance Panel
Hilton Zurich Airport Hohenbühlstrasse 10, 8152 Opfikon, Switzerland,

ZIP: Switzerland
Phone: 1 929 900 1853

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 records are the target of inspectors. The large number of FDA Warning Letters also demonstrate that the industry struggles with either understanding or implementing the regulations.

This 2-day interactive course provides the regulatory background and guides attendees through the complete equipment qualification 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 by attendees to easily implement what they have learned in the course.


Course Objectives:

  • Learn about the FDA requirements for equipment qualification according to Annex 15, USP <1058>, and computer system validation according to GAMP Guides
  • 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 each step and practices of instrument qualification and computer system validation
  • 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
  • Learn how to ensure and document integrity of raw data and other records according to Part 11 and Annex 11
  • Understand FDA's New and ongoing Part 11 inspection and enforcement practices
  • 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

Who Will Benefit:

  • IT/IS managers and system administrators
  • QA managers and personnel
  • Laboratory Managers and Supervisors
  • Analysts
  • Validation Specialists
  • Software Developers
  • Regulatory Affairs
  • Consultants
  • Documentation Departments
  • Training departments
  • Pharmaceutical development and Quality control laboratories
  • Quality control laboratories of API manufacturers
  • Contract laboratories
  • Contract manufacturers
  • Clinical Research Organisation
  • Suppliers and service providers of instruments and computer systems


Day 1 Schedule

Lecture 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 Systems"
Planning for cost-effective qualification and validation
Which instruments require qualification/validation

Lecture 2:
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, from the UK MHRA and from the WHO GMP data integrity guidelines
FDA/EU inspection and enforcement practices of electronic records: examples of recent FDA warning letters
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

Lecture 3:
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
Preparing and executing test protocols
Maintenance, requalification and change control

Lecture 4:
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
Going through examples for OQ and PQ testing
Writing the validation report
Day 2 Schedule

Lecture 1:
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
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

Lecture 2:
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

Lecture 3:
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 planning
Retirement of computer systems and data migration

Lecture 4:
Ensuring and documenting Integrity of Laboratory (Raw)data and other Records
Learnings from the new FDA guide: Data Integrity and GMP Compliance
Definition of raw data and meta 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
Steps for validating security and integrity functions
Examples how to ensure and document data integrity and security
Preparing your company for data integrity audits


Speaker Details

Dr. Ludwig Huber

Chief Advisor - Global FDA compliance, Labcompliance
  • Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferences
  • Served as 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 Systems.
  • Presenter of the Year of the Institute for Validation and Technology
  • Director and chief editor of, the global on-line resource for validation and compliance issues for laboratories.
  • Author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems"

Event Categories
Keywords: fun, Clinical , design , development , Fun , implement, industry , instruments, learn, pharmaceutical


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