Validation and Part 11 Compliance of Computer Systems and Data

Course "Validation and Part 11 Compliance of Computer Systems and Data” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

GlobalCompliancePanel Refer a Friend Program: Any Customer to 3 Referrals "Can Participate 2 Days Seminar for free of Cost

Overview:

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 numbers 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 , 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 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 report

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

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

Agenda:

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
Understanding the terminology: qualification, calibration, verification, validation.
EU/PICS GMP Annex 15: Validation and Qualification
USP Chapter 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 systems require qualification/validation

Lecture 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
System Suitability testing for performance qualification
Preparing and executing test protocols
Preparing inspection ready documentation
Maintenance, requalification and change control

Lecture 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
Rrisk assessment for type and extend 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

Lecture 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 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
Validation of mobile apps

Day 2 Schedule:

Lecture 1:

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 2:

Maintaining the validated state of computer systems

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

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, 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 4:

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
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:

Dr. Ludwig Huber

Chief Advisor - Global FDA compliance, Labcompliance

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

Location: Sydney, Australia Date:April 21^st & 22^nd, 2016 and Time: 9:00 AM to 6:00 PM

Venue: Hilton Sydney

Address: 488 George Street, Sydney, Australia 2000

Price:

(Without Stay) Price: $1,695.00 (Seminar for One Delegate)

(With Stay) Includes Price: $2,095.00 (Seminar for One Delegate)

Until March 10, Early Bird Price: $1,695.00 from March 11 to April 19, Regular Price: $1,895.00

Until March 10, Early Bird Price: $2,095.00 from March 11 to April 19, Regular Price: $2,295.00

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