Event Information



Validation and Part 11 Compliance of Computer Systems
Validation and Part 11 Compliance of Computer Systems


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.

Additional Bonus Material for easy implementation:

  • 70-page primer Analytical Instrument Qualification and System Validation (authored by Dr. Ludwig Huber)
  • 10 SOPs related to validation and qualification of analytical 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

Why should you attend?

  • Learn about the regulatory background and requirements for equipment qualification according to USP <1058>, 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
  • Understand and Implement  the new UK MHRA GMP Data Integrity Guideline
  • 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

Companies and Departments:

  • Pharmaceutical development and Quality control laboratories
  • Quality control laboratories of API manufacturers
  • Contract laboratories
  • Clinical Research Organization
  • Suppliers of analytical instruments and laboratory computer systems

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


Day One:

Lecture 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
  • 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"
  • Selecting the right validation approach for commercial off-the-shelf systems
  • Planning for cost-effective qualification and validation
  • Which instruments require qualification/validation

Lecture 2:

Going through the equipment qualification phases

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

Lecture 3:

Dealing with specific USP <1058> requirements

  • Qualification of firmware
  • Unplanned and routine maintenance
  • Change control
  • Time and event based requalification: the implortance 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

Lecture 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 and 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

Day Two:

Lecture 1:

Maintaining the validated State of computer systems

  • System maintenance
  • Change control: Handling planned and unplanned changes
  • How to deal with security patches
  • Periodic review vs. revalidation of chromatographic data systems
  • The approach and practice of periodic review
  • Using periodic review to reduce frequency of revalidation
  • Criteria for time based revalidation

Lecture 2:

Validation and Use 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:

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 GMP Data Integrity Guideline.
  • 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

Lecture 4:

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, Annex 11 and for the new UK MHRA GMP Data Integrity Guideline


Dr. Ludwig Huber

Chief Advisor - Global FDA compliance, Agilent Technologies

Dr. Ludwig Huber, Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. For more information, please visit Dr. Huber's website www.ludwig-huber.com

Date: April 28th & 29th, 2016                       Time: 9 AM to 6 PM

Venue Name & Address: The LaLiT Mumbai

Sahar Airport Road, Andheri East, Mumbai, Maharashtra – 400059

Price: ₹ 14,000

Register now and save 2000 (Early Bird)

Until March 15, Early Bird Price: 14,000 from March 16 to April 26, Regular Price: 16,000

Contact Address:

NetZealous BDA as GlobalCompliancePanel

Phone: 080-32528001

Fax: 080-25149544 

Email: customersupport@globalcompliancepanel.com

Website: http://www.globalcompliancepanel.in

Registration Link - http://bit.ly/Validation-and-Part-11-Compliance-of-Computer-Systems

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