About Computer System Validation Workshop


Validation of computer systems has become imperative over the last decades as it plays a crucial 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 FDA inspections. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory records are on target of inspectors. The large numbers of warning letters issued to pharmaceutical manufacturing companies also demonstrate that the industry struggles with either understanding or implementing the regulations.

To ensure that companies successfully pass FDA inspections and to also make sure that companies smoothly adopt latest tools & technologies available for validation, CPhI is pleased to announce the 5th Edition of ‘Computer System Validation Workshop’ which is scheduled on  15th -16th November 2018 at Meluha The Fern An Ecotel Hotel, Mumbai.

 The workshop will help you:

  • To understand regulatory requirements and risk-based approach under GAMP guidelines.
  • To deal with data integrity related issues with the support of good documentation practices.
  • To overcome challenges in adopting paperless validation tools

Workshop Trainer


Mr. David Hawley

Principal of David H Hawley Consultancy

Mr. David Hawley is a principal of David H Hawley consultancy, David Hawley was previously Senior Principal Consultant in the area of Regulatory Compliance and Computer Systems Validation and Director of Life Sciences for Business & Decision North America. Mr. Hawley has vast experience the life Sciences Industry, particularly in the areas of Validation and Compliance, IT Project Management, Cloud System compliance, ERP systems, Infrastructure Qualification & Management and Production Management of pharmaceuticals and medical devices. His key experience includes management, planning, and implementation of diverse IT, process and other projects in the Life Sciences Industry, particularly Computer System Validation; small systems to large implementations such as SAP, Oracle E-Business Suite, Microsoft AX and Epicor in the USA, UK, Ireland, mainland Europe, Asia and elsewhere. He has particular experience of Pharmaceutical and Medical Device production, IT Quality Systems, MES, Documentation Systems, CAPA, IT Quality and the compliance regulation of cloud-based systems. Mr. Hawley has over 30 years of experience in IT in the Life Sciences Industry, including 20+ years as part of the Pfizer group in the UK, and more than 14 years international consulting experience, with 10 years as Director of Life Sciences, North America for an international consulting company based in Paris. Mr. Hawley is a regular writer and presenter of a Life Sciences Web seminar series, writer of articles and presenter on the Life Sciences circuit. Mr. David Hawley has an excellent knowledge of 21 CFR Parts, 11, 210, 211, 600 and 820, Annex 11, ISO2000/ITIL ISO 27000 series, ISO14385, HIPAA, SOX, GAMP®5 and the associated GAMP Good Practice Guides.

Advisory Board Members


Sanjay Nandavadekar

Sanjay Nandavadekar

Director – IT, Cipla

Sachin Bhandari

Sachin Bhandari

Head-CSV, Sun Pharma

Manish Kumar Singh

Manish Kumar Singh

Associate Director - Regional Automation, Johnson & Johnson

Who should attend?


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

 

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

Key highlights/USPs of the workshop


A well-known trainer who will lead this 2-day workshop

Interactive case studies and exercises

12+ hours of extensive learning on cleaning validation from the guru of validation

Panel Discussion which will led by industry stalwarts from top pharma Indian companies

Key Topics of the workshop


Regulatory requirements & expectations for CSV - FDA, EU, WHO

GAMP5 guidelines – Risk based approach to be compliant with computerized system

Panel discussion on importance of data integrity in CSV

How to write effective and efficient test cases

Validation maintenance and preparing validation report

Adoption and implementation of ERP, cloud computing & mobile application

Discover the benefits of and paperless validation

Adopting ‘Paperless Labs’ – LIMS & EL

Sponsors


Media Partners

Venue


address

Meluha The Fern An Ecotel Hotel, Mumbai, Maharashtra, India

Contact Us


For Content

Amruta Manjrekar
+91 22 6172 7006
amruta.manjrekar@ubm.com

For Marketing & Communications

Steffi Misquitta
+91 22 6172 7082
steffi.misquitta@ubm.com

For Delegate Registrations

Ram Shukla
+91 99307 92737
Ram.shukla@ubm.com

For Delegate Registrations

Aparna Marar
+ 91 9619133045
Aparna.marar@ubm.com

For Exhibit and Partnership

Liza Bora
+91 96646 53691
liza.bora@ubm.com