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, behavioral and discipline issues also. It's 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 workplaces after this seminar they will have much more knowledge and tools to handle Data integrity issues at their workplace.

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

4. Please register the following delegate/s for
(For Additional delegates please photocopy this form)
Organisation Details & Authorization:
I / We Hereby Confirm To The Above And Authorize Our Participants To The Programme. Please Send The Invoice To:
Company Name:
Nominating Authority:
Designation: Email:
Company Postal Address:
Tel No.:
* This Booking is Invalid Without Signature
Signature
Participation Fees Include: Workshop kit Documentation, Refreshment, Luncheon, Certificate Of Participation
NON- RESIDENTIAL PROGRAM
Cell No.:
Marcep Inc. Terms and Conditions
Payment terms - Upon completion and return of the registration form, full payment is required not later
than 5 business days from the date of invoice. Payment must be received prior to the event date. Marcep
Inc. reserves the right to refuse admission to the event if payment has not been received.
Cancellation, postponement and substitution policy - You may substitute delegates at any time by
providing reasonable advance notice to Marcep Inc. In the event that Marcep Inc. postpones an event for
any reason and the delegate is unable to attend on the revised date, you will receive full credit of the
contract fee paid. On mutual agreement, you may use this credit for another Marcep Inc. event which must
occur within one year from the date of postponement. Except as specified above, no credits will be
issued for cancellations. There are no refunds given under any circumstances. Marcep Inc. is not
responsible for any loss or damage as a result of a substitution, alteration or cancellation/ postponement
of an event. Marcep Inc. will not take any liability whatsoever if the event is cancelled, rescheduled or
postponed due to act of God, natural calamities or any other emergencies. Please note that while course
speakers and topics were confirmed at the time of marketing, for circumstances beyond our control, the
organization reserves the right to substitute, alter or cancel the speakers and/or topics Marcep Inc.
reserves the right to alter or modify the speakers and/or topics if necessary without any liability to you
what so ever. Updates on any substitutions or alterations will be provided as soon as possible.
Discounts All 'Early Bird' Discounts require payment at time of registration and before the cut-off date in
order to receive any discount. Offered discounts by Marcep Inc. (including team discounts) must also
require payment at the time of registration. All discount offers will stand cancelled if payment is not
received at the time of registration.
For group nomination reply on:queries
info@marcepinc.com
Payment Terms:
Payment Is Required Within 5 Working Days From the Date
Of Invoice. Account Transfer/Cheque/DD Should Be In Favour
Of “Marcep Inc.” Payable At Par In Mumbai.
Investment fees
01 Delegate - INR: 24,500/- (Base Price)
Additional service tax of 15% is applicable
Sales Hotline No.:
or email: raj@marcepinc.com
7506478878
Marcep Inc.
Campz Landmark Bldg., 103, 1st floor,
Next to Tata Motors Showroom, S.V. Road,
Jogeshwari- West, Mumbai- 400102
Tel: 022- 30210100 Fax: 022- 30210103
info@marcepinc.com
PARTICIPATION DETAILS
Name: Designation: Email: Location:
www.marcepinc.com
R
Registration form:
Data Integrity Issues In Pharma Industry
And How To Prevent And Solve
th th
28 July - 29 July 2017
Mumbai