Sept 01-02, 2016 | Location: San Francisco, CA || Sept 15-16, 2016 | Location: Boston

2 Day Seminar

Assuring Data Integrity in the Life Science Industry

$895 For Each Attendee Limited Seats Left

Special Group Discount For Four Attendees

Chinmoy RoyBSEE MSCS

Subject Matter Expert: Data Integrity,

GAMP, CSV, CFR 21 Part 11, Annex 11,

Quality Risk Management,

Manufacturing Process Automation

and IT systems

Chinmoy Roy has 35+ years of

experience. He is an internationally

recognized subject matter expert in

Data Integrity, CSV, CFR 21 Part 11,

Annex 11 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 issue

In the face of aggressive audits by regulatory agencies, life sciences companies continue to face

unprecedented compliance challenges in ensuring data integrity. Such audits are unlikely to abate

anytime soon. On the contrary, the agencies are hiring very highly literate computer experts to audit and

aggressively pursue data integrity issues during audits. In the past four years, highly visible audits and

investigations coupled with aggressive prosecution have resulted in significant financial judgments

against even the most leading life sciences companies. Consequently, companies can no longer ignore

the heightened challenges of ensuring data integrity in their enterprise. Business expediency requires

them to train their personnel in understanding data integrity so that they can effortlessly identify and

remediate potential data integrity problems before the auditors do so.

This interactive two-day workshop planned by WCS provides attendees the opportunity to interact with a

Data Integrity Subject Matter Expert. Filled with numerous case studies from companies across the world,

this workshop provides participants with the knowledge, approaches and techniques to effectively

establish, monitor, control and assure the integrity of paper based and electronic data. It is designed for

novices as well as experienced personnel from QA, IT, manufacturing, laboratory, regulatory and

validation groups. It should also be of special interest to mid-level as well as senior level management.

Addressed will be data integrity case studies, inspection approaches and

483s and warning letters. Take back to your work, samples of Data

Integrity related SOPs such as corporate wide Data Integrity policy, data

integrity risk management, data integrity validation etc.

Area Covered

What is Data Integrity

Data Life Cycle design and controls

Attributes of Data Integrity and how they map to predicate rules

How do you know you have a Data Integrity problem in your

company

Elements of Data Integrity Assurance program.

Roles and responsibilities of different groups in ensuring Data

Integrity

What Data Integrity SOPs do auditors expect to see during audit and

should their contents be validating Data Integrity

Learning Objectives

What are the recent regulatory changes for Data Integrity?

What should be the management structure for DI accountability?

What are the documentation requirements for Data integrity?

What factors to consider before establishing a DI plan?

How does CFR 21 Part 11 requirements translate to data integrity

requirements?

What are the success factors for a DI program?

How is DI validated?

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

Regulatory Affairs

group, Quality Unit

Laboratory personnel

Users of Cloud

Clinical Trial Sponsors

Course Outline:

DaY ONE (08:30 AM to 05:00 PM)

Introductions by attendees

CFR 21 Part 11 unplugged

Meaning of Data Integrity (DI) and DI attributes

Principles of DI and role of Management, Business and IT in ensuring DI

Break

Distinctions between PQS, Data Governance and data management

What are the predicate rules for DI?

Lunch Break

Group exercise: Mapping DI attributes to Part 11 regulations

Data Lifecycle and Data states

Meaning of complete data, raw data and metadata

Break

Why and when Data Integrity issues occur

The DI framework elements in your enterprise that auditors expect to see

Principles of Ethical code conduct

Seminar 1 : Sept 01-02, San Francisco CA

Seminar 2 : Sept 15-16, Boston

DAY TWO (08:30 AM to 05:00 PM)

Summary of previous day’s Key Learnings

Using a data integrity based checklist to assess the DI health of your

enterprise

Data Integrity Maturity Model for your enterprise

Break

Configuration of audit trails for CDS software and other manufacturing

systems

Designing for and Validating Data Integrity

Lunch Break

Group exercise: Developing test scripts for validating Data integrity

What are Data Integrity SOPs

Some typical contents of DI SOPs

Break

DI Assurance Plan contents

Analyze Data Integrity 483’s and Warning letters issued in the past 3 years

Presentation of certificates of training