ence 2015 er Annual Conf Continuous

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Continuous

Manufacturing and Automation

Friday and Saturday

24th and 25th April 2015

Hotel Hyatt Regency, Mumbai

Continuous Manufacturing and Automation

Continuous Manufacturing has for some time been spoken about as the future of pharmaceutical production. ISPE India Affiliate has decided to take the lead and base a two-day event, its Annual Conference 2015, around this very subject. The conference will cover not just Continuous Manufacturing and Automation but various closely related aspects such as Validation, Regulation, Human Resources and much more.

This is in keeping with ISPE's goal to help the pharma industry in general and its members to stay at the leading edge of technical innovation and to fulfil ISPE's motto: “Connecting a World of Pharmaceutical Knowledge”.

The event

The conference will be on Friday and Saturday, the 24th and 25th of April, 2015. The venue will be Hotel Hyatt Regency in Mumbai. It is a two-day event and delegates will be required to attend both the days in order to receive their certificates.

Please note that spaces are limited and registrations will be accepted strictly on a first come, first served basis.

Why you should attend

If you work in the Indian pharma industry, whether in the technical or the marketing sides, this conference will be of crucial importance to you. For the first time you will get the opportunity to understand the future of Continuous Manufacturing in India, to ask questions that concern you and receive answers from the leading experts in their fields, and to ensure you are in a position to plan a Continuous Manufacturing future for your company.

An added bonus - Prize Event!

In order to ensure that we confirm learning through the course of the event, there will be a prize questionnaire given to every participant, the answers to which depend on the subject matter of the event, and the delegate with the most correct answers*, who submits the questionnaire on time, will receive, at the end of the second day a prize whose value is no less than Rs 40,000!

*If more than one delegate has the same number of correct answers, the winner will be chosen by drawing of names.

About ISPE

ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for 22,000 pharmaceutical science and manufacturing professionals in

90 countries. ISPE aims to be the catalyst for “Connecting a World of

Pharmaceutical Knowledge” by providing members with opportunities to develop technical knowledge, exchange practical experience and collaborate with global regulatory agencies and industry leaders.

ISPE India Affiliate Annual Conference at Hotel Hyatt Regency, Mumbai

Friday 24th and Saturday 25th April 2015

Continuous Manufacturing & Automation

Day 1

Time Topic Speaker

0830-0930 Hrs

0930-0940 Hrs

Registration

Welcome & Introduction Mr R Raghunandanan,

Chairman

ISPE India Affiliate

0940-1000 Hrs

1000-1020 Hrs

Address by Chief Guest

Address by Guest of Honour

Dr G N Singh,

Drugs Controller General India

Dr H S Kamble,

Commissioner,

FDA, Maharashtra

1020-1100 Hrs Address by Keynote Speaker Mr Damian Greene,

Immediate Past Chairman,

ISPE International Board of Directors

1100-1130 Hrs Networking Break

1130-1215 Hrs Regulatory Considerations for

Continuous Manufacturing

Dr Rapti Madurawe, US FDA

Division Director (Acting), Division I,

OPF, US FDA, CDER, OPQ

1215-1315 Hrs Why Continuous Manufacturing -

Technical / Scientific

Considerations

Dr Markus Krumme,

Head of Continuous Manufacturing,

Novartis, Switzerland

1315-1400 Hrs Networking Lunch and Exhibition

1400-1445 Hrs Facility of the Future Mr Jim Breen,

Senior Vice President, Engineering,

Johnson & Johnson

1445-1530 Hrs Cost of Quality in Continuous

Manufacturing scenario

Dr Fran Zipp,

President,

Lachman Consulting, US

1530-1600 Hrs Networking break

1600-1645 Hrs Human Factor in automation Mr Ronald Sequeira,

Executive Director, Human

Resources, GlaxoSmithKline,

Mumbai

1645-1715 Hrs Open Session

1715 Hrs Close of the Day’s Session

ISPE India Affiliate Annual Conference at Hotel Hyatt Regency, Mumbai

Friday 24th and Saturday 25th April 2015

Continuous Manufacturing & Automation

Day 2

Time Topic Speaker

0930-1015 Hrs New generation Equipment Dr Jochen Thies,

Head of Process Technologies,

Glatt Germany

1015-1100 Hrs

1100-1130 Hrs

1130-1215 Hrs

1215-1300 Hrs

1300-1400 Hrs

1400-1445 Hrs

1445-1530 Hrs

1530-1600 Hrs

1600-1645 Hrs

1645-1700 Hrs

1700-1715 Hrs

1715 Hrs

Continuous Manufacturing,

Technical Considerations with special reference to Granulation

Mr Dilip Parikh,

President

Dpharma Group Inc; US

Networking break

Computerised Systems in

Manufacturing Operations

Mr Timur Kabadayi,

Managing Director,

Conval Group, Turkey

Continued compliance through

Laboratory automation

Dr Ranjana Pathak,

Global Quality Head,

Cipla Ltd, Mumbai

Networking Lunch

Data integrity through automation Dr David Churchward,

Expert GMDP Inspector,

MHRA

Validation in Continuous

Manufacturing

Networking Break

Mr S C Singhai,

Chairman,

ISPE Hyderabad Chapter

Continuous Manufacturing,

Process Analytical Technology &

Process Control

(To be confirmed)

Open Session

Announcement of Quiz winner(s)

All speakers

Close of the conference

Payment/Conference contact

Completed form along with draft/cheque made payable to “ISPE India Affiliate” should be sent to:

Mr Amol Gamare, Executive, ISPE India Affiliate

1001 Dalamal House, 10th Floor, Nariman Point, Mumbai 400021

Tel: +91-22-30089476 email: admin@ispeindia.org / ispeindia@gmail.com

Hotel contact for preferential room rates

* 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

Cancellation policy

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.

Registration Fees

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.

Hurry

Due to limited availability, places at the Conference will be allocated on a first come, first served basis.

Member

Basic Rate Service Tax

12.36%

Total (INR)

Non Member

Basic Rate Service Tax

12.36%

Total (INR) Basic Rate

Student Member *

Service Tax

12.36%

Total (INR)

8900 1100 10000 13350 1650 15000 4450 550 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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Front Cover picture credits (l to r):

Science Museum London, Skolkovo Foundation, epSos .de

Used under Creative Commons License: http://creativecommons.org/licenses/by/4.0/legalcode

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