CSV Brochure 14072014

Computer Systems Validation
For Pharma & Biotech
GAMP5, Compliance and beyond Goa: 15
November 2014
Hyderabad: 17 November 2014
Ahmedabad: 19 November 2014
2
ABOUT THE PROGRAM
Goa
Hyderabad
Ahmedabad
Computer Systems Validation
Computerized systems are used extensively to capture, analyze and store data, report information and to
control equipment and processes in the life sciences industry at laboratories and manufacturing facilities.
Internal and external audit of pharmaceutical and biopharmaceutical industry has consistently indicated a
lack of validated computer control in the industry. Computer validation has become one of the key areas of
strong emphasis for regulatory agencies such as Food and Drug Administration (FDA-US), and EU.
This training course provides the fundamentals required to understand the methodology used to validate a
computer-related system. Practical recommendations on how to increase efficiency and ensure that
validation is performed correctly the first time, are used through the entire course. The concepts introduced
provide a comprehensive framework for validation of computerized systems and present a logical and
practical approach to the validation of any computerized system to meet both regulatory concerns and
business needs within the pharmaceutical environment.
Our Expert Speaker
Managing Director, CONVALgroup, Life Science Consulting Pvt. Ltd.,
Toronto, CANADA - Istanbul, TURKEY - Pune, INDIA (2000 onwards),
 Evaluation of Complex and Significant Compliance Problems
 Design and Management of Corrective Action Programs
 Regulatory Training such as Computerized System Validation,
Risk Management
 Quality System Improvements
 Computerized Systems/Facilities/Equipment Qualifications such as ERP
TIMUR KABADAYI, M.Sc., MBA
Systems (SAP, JDEdwards), MES Systems (WERUM), Lab System (CDS,
LIMS, CDMS), BMS Systems, Automation Systems
 Reference Projects: Eczacıbası Zentiva, Abdi Ibrahim, Baxter, Bilim, GSK
Turkey, Roche Shanghai, Roche Turkey, Sandoz, and Mefar
Manager Software Testing and Validation, APOTEX INC. Toronto, CANADA (1998-2003)
 Lead the 21 CFR Part 11 Compliance and Remediation Project
 Validation Strategies for Major IT Projects such as SAP R/3 Version 4.6C All Modules, HP ChemStation Upgrade and
ChemStore Implementation, Oracle Clinical, Document Management Software Bladerunner, NuGenesis, Labware
LIMS, and Network Validation.
 Vendor audits such as Oracle, SAP, e-Vault, Watson LIMS, Labware LIMS
 Preparation of Validation Policies and Procedures for the Apotex Global Group of Companies
 Liaison with Regulatory Agencies on the Computerized Systems
Compliance Issues
Manager Plant Engineering, ECZACIBASI PHARMA Lüleburgaz, TURKEY (1992-1998)
AGENDA
Computer System Validation For Pharma & Biotech
“GAMP5, Compliance and beyond”
Goa: 15 November2014
Hyderabad: 17 November 2014
Ahmedabad: 19 November 2014
Time
09.00am - 09.30am
Topic
ISPE & Membership
By
ISPE Board Member
Lecture 1
09.30am - 11.00am
Generic Validation, GAMP and user- supplier relationship
11.00am - 11.15am
TEA BREAK
Timur Kabadayi
Lecture 2
11.15am - 12.15pm
US and EU Guidelines on CSV
Timur Kabadayi
12.15pm - 01.30pm
VMP, User Requirement Specifications, DQ,IQ,OQ,PQ
Timur Kabadayi
01.30pm - 02.15pm
LUNCH
02.00pm - 03.00pm
VMP, User Requirement Specifications …( Continued)
Timur Kabadayi
03.00pm - 04.15pm
CFR 21 Part 11 Electronic records and signature
Timur Kabadayi
04.15pm - 04.30pm
TEA BREAK
Lecture 3
Lecture 4
Lecture 5
04.30pm - 06.00pm
Integrating Manufacturing / Testing systems in ERP
Timur Kabadayi
About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is the World’s largest not-forprofit association serving its Members through leading scientific, technical and regulatory
advancement throughout the pharmaceutical lifecycle. The 20,000 Members of ISPE are building
solutions in the development and manufacture of safe and effective pharmaceutical and biologic
medicines and medical delivery devices in more than 90 countries around the world. Founded in
1980, ISPE has its worldwide headquarters in Tampa, Florida, USA. Visit www.ISPE.org for
additional Society news and information.
CONFERENCE CONTACTS
TRAVEL AND HOTEL
Amol Gamare, Executive
ISPE India Affiliate
Cell: +91.9702187849, Tel: +91.22.30089475/6
email: [email protected] / [email protected]
* Participants get special rates on hotel booking for ISPE Conference: please
mention that you are attending at time of booking.
ISPE India Affiliate
1001, Dalamal House, 10th Floor, Nariman Point
Mumbai 400021
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 organization.
PLEASE CONSIDER THIS FORM AS AN INVOICE
Computer Systems Validation:
“GAMP5, Data Integrity, Compliance and beyond”
Goa - Hyderabad - Ahmedabad
REGISTRATION FEES
Registration fee includes refreshment breaks, and will be accepted by mail/courier.
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.
Mem ber
Non Mem ber
St udent Mem ber*
Basic Rate Service Tax Total (INR)
12.36%
Basic Rate Service Tax Total (INR)
Basic Rate Service Tax Total (INR)
12.36%
3000
371
3371
12.36%
433
3500
3933
1500
185
1685
*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.
REGISTRATION TERMS AND CONDITIONS: Registration form should be duly filled and signed by the authorized person.
You are requested to email the duly filled and signed Registration Form first and then courier/mail
it along with registration fees on or before 5 working days prior to the event.
PAYMENT INFORMATION
Please check the applicable category:
Non-Member
ISPE Member : ID No.:
Completed form along with draft/ cheque made payable to “ISPE India
Affiliate” should be sent to:
Amol Gamare
Please tick the venue:
Goa
Hyderabad
Executive,
ISPE India Affiliate
1001, Dalamal House, 10th Floor, Nariman point,
Mumbai - 400021
Cell: +91.9702187849, Tel: +91.22.30089475/6
email: [email protected] / [email protected]
Ahmedabad
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email (Required for confirmation)*
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