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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. | |
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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
Seminar Fee Includes:
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
Companies and departments:
- Pharmaceutical development and Quality control laboratories
- Quality control laboratories of API manufacturers
- Contract laboratories
- Clinical Research Organization
- Suppliers and service providers of instruments and computer systems
Course Outline:
Sessions indicated with (*) include one or more workshop exercises
| Day One (8:30 AM - 4:30 PM) | Day Two (8:30 AM - 4.30 PM) | ||
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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
Module 2 (*) Going through the equipment qualification phases
Module 3 (*) Cost Effective Validation of Computer Systems: Step-by-Step – Part 1
Module 4 (*) Validation of Computer Systems – Part II
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Day 2 - Lectures and Workshop Exercises Module 5 (*) Validation and control of Excel spreadsheet applications
Module 6 (*) Maintaining the validated State of computer systems or Control of Operation and Retirement
Module 7(*) Introduction to FDA 21 CFR Part 11 and EU/PICS Annex 11
Module 8(*) Ensuring and documenting Integrity of Laboratory (Raw)data and other Records
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®GAMP is a registered trademark and stands for Good Automated Manufacturing Practice
®Excel is a registered trademark of Microsoft
The concept
- 50 % of the time will be dedicated to workshop type exercises using prepared fill-in templates and to interactive discussions
Meet Your Instructor
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Dr. Ludwig Huber Chief Advisor - Global FDA Compliance, Labcompliance
For more information, visit www.ludwig-huber.com/qualification |
Register Now
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- Fill this form with attendee details & payment details
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Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]
Payment:
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Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.
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