Your Survival Guide for Tomorrow
Process Validation is a Quality and Business critical process in the Pharmaceutical industry and an essential element of GMP.
Processes that are not validated in a robust manner could endanger patient safety.
For successful completion of process validation a gamut of other validations and qualifications need to be completed and that includes facility and equipment qualification, utilities qualification, cleaning validation, analytical method validation etc.
All these make validation documentation complex and crucial.
Regulatory agencies across the globe have stringent expectations for validation and qualification and the success of a pharmaceutical organization depends how well it is equipped to face these challenges.
Introduction of ICH Q8, Q9, Q10 and Q11 as well as the changes made by FDA and EMA in their
Validation and Qualification guidelines make it all the more important for the industry to understand these challenges.
ISPE, recognising these challenges, brings to you a two day conference exclusively on validation and we are sure participants will immensely benefit from this event.
Eminent speakers and Subject Matter Experts from industry will help you understand the detailed aspects of all the topics covered.

0830 – 0930 Hrs Registration
0930 – 0940 Hrs
0940 – 1000 Hrs
1000 – 1020 Hrs
1600 – 1630 Hrs
1630 –1715 Hrs
Welcome & Introduction
Address by Chief Guest
Address by Guest of Honour
Chairman ISPE India Affiliate
Dr. Prakash Mody, Chairman &
Managing Director, Unichem
Laboratories
Dr. G. N. Singh, Drugs
Controller General India (To be confirmed)
To be confirmed 1020 – 1100 Hrs
1100 – 1130 Hrs
1130 – 1230 Hrs
1230 – 1330 Hrs
Address by Keynote Speaker
Networking Break
Process Validation – FDA
Perspective
Process Validation – EMA
Perspective
1330 – 1430 Hrs
1430 – 1515 Hrs
1515 – 1600 Hrs
1715 – 1730 Hrs
1730 Hrs
To be confirmed
To be confirmed
Networking Lunch & Exhibition
Overview of the Process Validation
Landscape - From QbD into PV and various international PV guidance.
Mr. Maurice Parlane,
Director, CBE Pty Ltd and New
Wayz Consulting Ltd, New
Zealand
WHO-Non-Sterile Process
Validation
Dr.Vimal Sachdeva,
Technical Officer - WHO
Geneva
Networking break
Process Validation for Legacy
Products - How to approach PV for a Legacy Product
Mr. Maurice Parlane,
Director,
CBE Pty Ltd and New Wayz
Consulting Ltd, New Zealand
Open session
Close of the day's sessions
.

0930 – 1015 Hrs New Approaches to Cleaning
Validation
To be confirmed
1015 – 1100 Hrs
1100 – 1130 Hrs
EU Guidelines for GMP - Annex 15,
Qualification & Validation
To be confirmed
Networking break
1130 – 1215 Hrs
1215 – 1300 Hrs
QbD approach to Analytical Method
Development and Validation
Ms. Vanishree Acharya,
Managing Director and SME-
Life Sciences
Kromaspects SciTec Solutions
Pvt. Ltd.,Bangalore.
Contamination control through
ASTM E2500 based HVAC system qualification
Mr. Sasidharan Menon,
Subject Matter Expert (SME) -
Design & Evaluation
Controlled Environments for
Contamination Control
1300 – 1400 Hrs Networking lunch
1400 – 1445 Hrs
1445 – 1530 Hrs
Analytical Equipment Qualification
Pharmaceutical Water System
Qualification
Ms. Vanishree Acharya,
Managing Director and SME-
Life Sciences
Kromaspects SciTec Solutions
Pvt. Ltd.,
Bangalore.
To be confirmed
.
1530 – 1600 Hrs Networking Break
1600 – 1645 Hrs Data Integrity and Quality of
Documents
Dr. Ranjana Pathak, Head of
Global Quality, Cipla Limited,
Mumbai
All speakers 1645 – 1715 Hrs Open session
1715 Hrs Close of the conference

Completed form along with draft/cheque made payable to “ISPE India Affiliate” should be sent to:
Secretariat, ISPE India Affiliate
1001 Dalamal House, 10th Floor, Nariman Point, Mumbai 400021
Tel: +91-22-30089476 email: admin@ispeindia.org / ispeindia@gmail.com
* Participants get special rates on hotel booking for ISPE Annual Conference: please mention that you are attending at time of booking.
Ms Anokha Kumar, Sales Manager
Hyatt Regency, Mumbai, Sahar Airport Road, Andheri East, Mumbai 400099
Tel: +91-22-66961419 Mob: +91-9820918323 Fax: +91-22-66961235 email: anokha.kumar@hyatt.com
After payment no refund will be given on cancellation, delegate name may be substituted with another, ISPE will not be responsible for any loss or damage, alteration or cancellation by your organisation.
Join ISPE now to qualify to save on future events and to receive all the benefits of membership. To see all the benefits of ISPE membership, visit www.ispe.org and click on Join Membership.
Due to limited availability, places at the Conference will be allocated on a first come, first served basis.
Member
Basic Rate Service Tax
14.5%
Total (INR)
8734 1266 10000
Non Member
Basic Rate Service Tax
14.5%
Total (INR)
13100 1900 15000
Basic Rate
Student Member *
Service Tax
14.5%
Total (INR)
4367 633 5000
*A limited number of student registrations are available.
A student is an undergraduate/graduate who can document enrolment in a Signature accredited, degree granting, academic program. Please send completed registration form, copy of student identification, and payment.
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