Computer Systems Validation Workshop 2017

CSV WORKSHOP 2017

Validation of computer systems has evolved over the last decade and now it is considered as an integral part of GxP requirements. While the methodology has developed and advanced with latest version of GAMP guidelines, the complexity of software technology still leaves a gap between the regulatory expectations and the awareness of the guidelines. This can result into increased scrutiny by FDA which may lead to warning letters received by pharmaceutical companies.

To ensure that companies successfully pass FDA inspections and to also make sure that system and its applications fulfil its intended purpose, CPhI is pleased to announce the 4th Edition of ‘Computer System Validation Workshop’ which is scheduled on 9th -10th November, 2017 in Mumbai.

The workshop will help you:

  • To understand regulatory requirements and risk based approach under GAMP5 guidelines.
  • To deal with data integrity related issues with the support of good documentation practices.
  • To know overall challenges that occurs during validation and strategies to overcome those challenges.

TRAINER

Sam Brooks

Co-Chair of GAMP Europe Steering Committee

Sam Brooks is a governance, risk management and compliance expert with more than 20 years’ experience in pharmaceuticals. Trained as an instrument and control engineer, his roles have included development of real-time systems, manufacturing business improvement and CSV. He spent 10 years with Novartis ultimately leading the global Information Governance and Management function for Animal Health and OTC Divisions. He is now principal consultant and director at Brooks I3 Ltd delivering information and systems governance and compliance services to the life-sciences sector.

KEY TOPICS OF THE WORKSHOP

  • Regulatory requirements and recommendations under the 21CFR Part 11
  • EMEA Annexure 11 for Computer Systems Validation
  • Strategies for Good Documentation practices
  • Risk Assessment for software and systems
  • Cloud and Mobile Application Validation
  • How to validate and qualify PLC machines
  • Achieving compliance by building a complete understanding of GAMP 5
  • Recent 483s issued on CSV & data integrity
  • Special session by Indian Pharma Expert on ‘Enterprise Application Validation’

KEY HIGHLIGHTS/USPS OF THE WORKSHOP

  • Content covering major reasons included in the recent warning letters issued to Indian pharma companies
  • Trainer with expertise in GAMP
  • Interactive case study/ exercises and dedicated Q&A sessions
  • Special session by top notch CSV expert from Indian pharma industry

COUNTDOWN TO THE EVENT

 

Register Today

WHO SHOULD ATTEND?

Managers/Senior Managers/ Assistant Managers/ General Managers/ Plant head/ Site Head from:


Quality Assurance

Quality Control

IT

R&D

VENUE

EVENT PARTNERS

Exhibit Partner

Media Partner