Trainings By Informa Markets in India
Informa


Data Integrity and Computer System Validation Workshop

04 Nov - 05 Nov 2020   |   Virtual Course


Course Overview

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.

It has been well over 15 years since the US FDA issued their last guidance on computer system 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

Easy networking opportunities
Well-known trainers who will lead this 2-day workshop
Interactive case studies and exercises
12+ hours of extensive learning on Data Integrity and Computer System Validation
Case studies & practical sessions
Dedicated Q&A sessions with the trainers

Benefits of Attending


Understanding and adoption of GAMP 5 guidelines
Learnings from warning letters issued with real-time case studies and group exercise
Comprehending the importance of good documentation practices
Expertise the 5 key elements of Data Integrity and setting up Audit trail review SOPs
Apprehending regulators (FDA & EMA) perspective on DI & CSV
Learning risk mitigation techniques using design architecture of PLC/DCS/MES automation system

Speakers

Chinmoy Roy

BSEE, MSCS
Specialist: GAMP, CSV, CFR 21 Part 11, QRM, Manufacturing

Sam Brooks

Trainer & Principal Consultant

Who Should Attend?


Industries

  • Pharmaceuticals
  • APIs
  • Life sciences
  • Bio-Pharmaceuticals

Designation

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

Departments

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




Similar Courses


Oops, no record found!