Validation and Part 11 Compliance of Computer Systems and Data

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 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
  
  

Registration Details:

NetZealous - GlobalCompliancePanel

NetZealous Services India Pvt. Ltd.
Gururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar, 
Bangalore - 560078 Karnataka, INDIA

Phone:  1800 425 9409 

Fax:  080-25149544 

[email protected]

http://www.globalcompliancepanel.in/

Registration Link - http://www.globalcompliancepanel.in/control/validation-part-11-compliance