The document addresses data integrity issues within the pharmaceutical industry, emphasizing the importance of accurate and reliable data for producing safe medicines. It outlines the key attributes of data integrity and discusses the various challenges faced by Indian pharmaceutical companies, including multiple warning letters from the US FDA. The upcoming seminar, scheduled for July 28-29, 2017, in Mumbai, aims to provide solutions and best practices for addressing these challenges and improving compliance with regulatory standards.

1. Data Integrity Issues In Pharma Industry
And How To Prevent And Solve
The integrity of the data collected and recorded by pharmaceutical manufacturers is critical to ensuring that
high quality and safe medicines are produced. What exactly is data integrity and why is it so important?
Data rising to the standard that is commonly referred to as having “integrity” generally include five key
attributes:
Accuracy – no errors or editing without documented amendments
Attributable – information lists who acquired the data or performed an action and when
Available – for review and audit or inspection over the lifetime of the record
Complete – all data are present and available
Consistent – all elements of the record, such as the sequence of events, are dated or time stamped in
expected sequence
For last four years Indian pharma industry is struggling with issues in their documentation, lab operations and
procedures issues regarding Data integrity and reasons for same are multiple at multiple levels right from Top
management attitude and involvement in such issues.
About 36 warning letters have been issued to Indian companies and asked to get external consultants to resolve
such issues by US FDA.
This seminar will go through actual issues one by one, will deal will related subjects such as 21 CFR part 11
requirements, computer system validations, OOS issues, good document practices, behavioural and discipline issues
also.
Its not enough just to know what is bugging Indian industry, but this seminar will give solutions, suggestions,
deterrents to tackle Data integrity issues and hence when participants go back to their work places after this seminar
they will have much more knowledge and tools to handle Data integrity issues at their work place.
Introduction:
Pharma Painpoints:
th th
28 July - 29 July 2017
Mumbai
02 Days International Forum
Let’s make your pharmaceutical asset safe & better !
For registration & enquiries contact Ms. Hema on: hema@marcepinc.com or Tel: +91- 22- 30210100
www.marcepinc.ininfo@marcepinc.in Cell: 7506478878
We will be proud to become your in house training & business consultancy partner for your workforce & plant
development. For any tailor made training’s or consultancy at your facility in any industry vertical’s just email us
on: hema@marcepinc.com or raj@marcepinc.com
Course Directors: Mr. R. R. Vidwans & Mr. B. K. Reddy
R
An ISO 9001:2015 CERTIFIED COMPANY

2. 1. Data Integrity: In Production: Details of issues. Solutions, deterrents and what companies are doing to solve
this problem
What is data integrity issue?
What the guidelines mention about DI
Why companies face these issues
What are few examples in day-to –day of DI
What companies are doing to prevent these issues
What are the solutions?
2. Data integrity in laboratory environment
3. Recent Data integrity issues in warning letters and how to solve those
Laboratory examples of DI
DI in production and process
What FDA wants from such companies
How to prevent DI issues sited in warning letters
4. Quality matrix by US FDA
5. 21 CFR Part11 and EU Annex 11 Requirements cGMP environment
6. Laboratory compliance and chromatography validation
7. Good Laboratory Compliance Program and Process Mapping Techniques
8. Validation of Computerized Systems in cGMP environment
9. Case Studies and Group Discussion
1. Data Integrity: In Production: Details of issues. Solutions, deterrents and what companies are doing to solve this
problem.
2. Recent Data integrity issues in warning letters and how to solve those.
3. Good documentation practices and DI
4. Data integrity in laboratory environment
5. 21 CFR Part11 and EU Annex 11 Requirements cGMP environment
6. Good Laboratory Compliance Program and Process Mapping Techniques
7. Validation of Computerized Systems in cGMP environment.
8. Validation of Chromatographic systems
You will learn how to:
Two Days Training Agenda
For registration & enquiries contact Ms. Hema on: hema@marcepinc.com or Tel: +91- 22- 30210100
www.marcepinc.ininfo@marcepinc.in
By R. R. Vidwans and B. K. Reddy
Data Integrity Issues In Pharma Industry
And How To Prevent And Solve
th th
28 July - 29 July 2017
Mumbai
02 Days International Forum
Reduce Cost, Improve Quality & Avoid FDA 483 Warning Letters

3. Hoechst, Core, Wockhardt, Serum Institute in 35 years of
practical experience.
In addition to QA, GMP, operational help to
pharmaceutical companies for their US FDA, MHRA,
TGA audits, and establishing complete QA systems in
companies, we have now started training of company
employees in their premises for aseptic processing,
clean room behavior, FDA 483s and how to reduce them,
Quality systems training at Hoechst, Core, Senior
consultant (GMP, quality systems, audits, Injectable
trouble shooting, projects). at PCS Netherlands and
independent associate with a European consulting
company for audits, quality systems, GMP training
Course Director: R. R. Vidwans
Course Director: B. K. Reddy
Product Validations, QC Laboratory Compliance, 21CFR
Part 11 & EU Annex 11 Compliance, cGMP related
Computer System Validations, Analytical Method
Validations, Stability Studies, Product Cleaning
Validations, Data Integrity Systems, Regulatory
Compliance and Quality Management System
Implementation. Hands on experience in implementation
of 21 CFR Part 11 and EU annex 11 requirements.
Investigation of Product Failure Investigations Out of
Specification (OOS) results and provides scientifically
justified corrective and preventive actions.
For registration & enquiries contact Ms. Hema on: hema@marcepinc.com or Tel: +91- 22- 30210100
www.marcepinc.ininfo@marcepinc.in
Data Integrity Issues In Pharma Industry
And How To Prevent And Solve
th th
28 July - 29 July 2017
Mumbai
02 Days International Forum

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Data Integrity Issues In Pharma Industry
And How To Prevent And Solve
th th
28 July - 29 July 2017
Mumbai