Live Webinar Computer Systems Validation and Data Integrity for Laboratories

Overview

Data Integrity audits project a moving goal post.  Issues that were top warning letter vote getters have made way for newer ones to include Cybersecurity etc. Our Data Integrity courses which are offered around the world are renowned for addressing such evolving trends.  Consequently, they have attracted record attendances.  Attendee feedback suggests the uniqueness of our offerings.  Particularly significant is the feedback from those who attended similar courses offered by other companies.Chinmoy Roy, our course instructor, is one of the world’s first to design, implement and obtain “fit for use” certification for the world’s largest paperless biologics manufacturing facility in the late 1990s. He is a practicing Data Integrity auditor.  Former FDA inspectors include him on their 3rd party and mock audit teams.  He also continues to provide consulting services in the design and implementation of Data Integrity infrastructures to major multinational companies.  His lucid and pragmatic presentation style and interaction with the trainees/conference attendees, has earned him the “Speaker of the year” award from attendees of the world’s prestigious conference on Data Integrity. The webinar will address inspection approaches and trends and how regulatory agencies view data integrity.  The webinar will also include a primer on CSv, which is also a critical component of Data Integrity that we neglect. This webinar is for novices as well as experienced personnel from QA, IT, manufacturing, regulatory and validation groups.

Session Highlights

•  What is Computer Systems Validation (CSV)

•  Why is URS a key deliverable of CSV

•  What are the Good Quality Attributes of a URS

•  What is Data Integrity

•  What is US FDA’s position on Data Integrity

•  How FDA audits Data Integrity

•  Data provenance and how regulators use it to determine data integrity

•  Which group is primarily responsible for Data Integrity in a company

•  And much, much more…

Who will benefit

• Pharmaceutical industry / Medical device industry / Healthcare industry personnel 

• Developers of software for use in Life Sciences industry

• Validation service providers, IT service providers

• Manufacturing personnel, Manufacturing Automation system vendors and system integrators

• Laboratory personnel

• Users of Cloud

• Clinical Trial Sponsors

• Regulatory VP

• Quality VPs

• IT VPs

• Regulatory Affairs Professionals

• Quality Managers

• Quality Engineers

• Small Business Owners

• GxP Consultants

Meet Your Presenter 

Chinmoy Roy BSEE, MSCS US FDA Expert Data integrity & CSVSubject Matter Expert: Data Integrity, GAMP, CSV, CFR 21 Part 11, Annex 11, Quality Risk Management, Manufacturing Process Automation and IT systemsChinmoy Roy has 37+ years of experience. He is an internationally recognized subject matter expert in CSV, CFR 21 Part 11, Annex 11, Data Integrity and manufacturing process automation systems. He has been invited to speak and conduct training workshops at several international conferences such as ISPE, WBF, Shimadzu’s annual conference for Asia Pacific, etc.His expertise stems from his experience in implementing and obtaining “fit for use” certification for over 200 IT systems. He has worked at and consulted with leading US based companies such as Roche, Genentech, Bayer, Novartis, Johnson and Johnson etc. His pioneering efforts in implementing CFR 21 Part 11 compliant manufacturing IT systems in 1999 while employed by Genentech, was a precursor to FDA’s issuance of Part 11’s Scope and Application guidance in 2003. His workshops are unique in that he blends his field experience to provide case studies to explain the intricacies of implementing regulations. Chinmoy is an Electrical Engineer and a Computer Science post graduate.

For more Details please Contact:
SADIYA SHABREEN Conference Manager
PH. +91 080-48520271 / 9742954444
Email.sadiyas@worldcomplianceseminars.in