Trainings By Informa Markets
Informa


Data Integrity & Computer System Validation Workshop 2021

15 Mar - 17 Mar 2021   |   Virtual Course


Course Overview

DATA INTEGRITY

Data Integrity (DI) has become a focal point of FDA inspections, as is evidenced by the number of warning letters citing data integrity and the resulting number of import alerts. With increased reliability on computers and automated systems, it is extremely vital for a pharmaceutical organization to ensure efficacy, quality and safety of drugs. Company Quality Management Systems are being scrutinized as to how the integrity of raw data (both electronic and manual) generated in the Quality Control Laboratory and in Operations (Manufacturing and Engineering) can be assured.

COMPUTER SYSTEM VALIDATION

It has been well over 15 years since the US FDA issued their last guidance on Computer Systems Software Validation. Since then, the computing and controls technologies have undergone a significant evolution to include Cloud Computing, Agile Software Development, Paperless validation, Mobile Computing, Artificial Intelligence, Lab Robotics System etc.
Validation of computer systems has become imperative over the last decades as it plays a vital role in getting compliant with GAMP guidelines. As there are latest tools & technologies available to validate computer systems, pharmaceutical manufacturing companies have to meet regulatory guidelines and expectations to avoid 483s and pass regulatory inspections.

Program Focus

DATA INTEGRITY
Setting the scene: What is DI and why is it important
How to implement data governance
Risk Assessment in Data Integrity
Understanding data integrity by design & its implementation
Implement Best DI practices for lab & manufacturing records
COMPUTER SYSTEM VALIDATION
Regulatory Imperative / Overview
Leveraging suppliers involvement in system validation
CSV Processes and Deliverables
Requirements Management and Risk Based Testing
Understand & using Computer System Assurance (CSA)
Audit and Inspection Readiness: What is an inspector looking for?

Benefits of Attending


Learn how to implement GAMP 5 guidelines

Overcoming challenges on adopting Computer System Assurance

Understanding regulatory requirements & audit trail in Data Integrity

Learning from past 483s & warning letters on CSV & DI

Who Should Attend?


 

Industries

 

  • Pharmaceuticals
  • APIs
  • Life sciences
  • Bio-Pharmaceuticals

 

Departments

 

  • Quality Assurance
  • Quality Control
  • IT
  • Validation
  • R&D

 

Designation

 

  • Vice Presidents
  • Associate Vice Presidents
  • CQA Heads/ Plant Heads
  • Deputy General Managers
  • General Managers
  • Senior Managers
  • Managers
  • Assistant Managers
  • Senior Executives




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