Practical Quality Management and Data Integrity
Seminar
Tuesday 12th December 2017
Convention Hall C-D, Ambassador Hotel Bangkok, 171 Sukhumvit Soi 11, Bangkok 10110, Thailand
(BTS Nana Station Exit 3), http://www.amtel.co.th/
BACKGROUND AND OBJECTIVE
Data integrity has become a major institutional challenge as big data analytics increasingly drives
decision-making. To guarantee data integrity, organizations need to establish strong Quality
Management Practices that will help protect and maintain data during its life cycle i.e. from initial
generation and recording, through processing, use, archiving, retrieval, and (where appropriate)
destruction.
Recently, several pharmaceutical firms around the world are getting several FDA warning letters on
data integrity violations. Several regulatory organizations have published guidelines and guidance
regarding data integrity. Attention on Data Integrity to electronic records is primality because these
systems have not yet been as closely examined as traditional paper based systems. However,
whether records are paper or electronic does not really matter. The core principles of Data Integrity,
i.e. ALCOA+, apply to both.
The ISPE Thailand seminar on Practical Quality Management and Data Integrity will enable you to
view Data integrity as a whole system or all components of the system starting from organization,
culture, and oversight. Throughout the meeting, you will learn more about challenges and
opportunities that our region faces in establishing an effective Quality Management System and how
this is the basis for effective Data integrity. Best practices for introducing and managing Data
integrity in your organization, especially paper based systems, will be covered.
Importantly, this seminar promises a unique opportunity for interaction between you, the
pharmaceutical industry, and Thai FDAs for their point of view on Data integrity.
The objective of the seminar includes:
• Update on Thai FDAs perspective on Data integrity
• Realize the importance of Quality Management System, which is the basis for Data integrity
• Understand the key challenges and opportunities in establishing effective Quality
Management and Data integrity system
• Comprehend the principle of Data integrity for both paper based and electronic systems
• Learn how to apply the principle of Data integrity in practice via case studies
• Refine your organizations’ Data integrity mechanisms in place to meet the needs of
regulatory requirements and current best practices
Practical Quality Management and Data Integrity
Seminar
Tuesday 12th December 2017
Convention Hall C-D, Ambassador Hotel Bangkok, 171 Sukhumvit Soi 11, Bangkok 10110, Thailand
(BTS Nana Station Exit 3), http://www.amtel.co.th/
In addition, benefits of the seminar include interacting and exchanging ideas among delegates, Thai
FDAs and the trainers. Delegates will have the opportunity to discuss their challenges and problems
Get to know Speaker
Dr. Anthony Margetts
Dr. Anthony Margetts is Principle Consultant for Factorytalk’s Compliance department and a highly experienced and leading international Pharmaceutical and Chemical engineering practitioner and project manager with +30 years working experience in the chemical/pharmaceutical/medical device industries. Professional Qualifications:
• BSc Chemical Engineering, Birmingham, UK, 1967
• PhD Chemical Engineering, Birmingham, UK, 1971 • Chartered Engineer 1979
Relevant professional experiences
As Principle Consultant, Dr Margetts leads key compliance consulting assignments. He is considered a global expert in the fields of GMP compliance and validation for the Pharmaceutical and regulated industries. He worked for AstraZeneca (formerly Zeneca and ICI Pharmaceuticals) since 1988. He has been
responsible for a variety of international projects, e.g. leading teams responsible for technical
transfers, new product introductions and preparations for international, European and US FDA pre-
approval and regulatory inspections. During his time at ICI/Zeneca/AstraZeneca he managed the
introduction of new medical device products, including setting up global supply chains and ensuring
their compliance to international standards.
Practical Quality Management and Data Integrity
Seminar
Tuesday 12th December 2017
Convention Hall C-D, Ambassador Hotel Bangkok, 171 Sukhumvit Soi 11, Bangkok 10110, Thailand
(BTS Nana Station Exit 3), http://www.amtel.co.th/
During the 1990’s he managed the introduction of new world-wide validation procedures and was
the Chairman of a UK Pharmaceutical Industry Group charged with writing a Guideline on Computer
Systems Validation which evolved over a number of editions and expanded from UK through Europe,
USA and Japan and is now called the Good Automated Manufacturing Practice (GAMP) Guide. Dr
Margetts was chairman for the editorial review of the latest version GAMP 5, published in 2008
which has now become the world wide reference for Computer Validation in the Healthcare
Industries.
Dr. Anuchit Sekthira
Dr. Anuchit Sekthira is associate director, validation global quality assurance Americas in leading pharmaceutical company in the USA with +30 years working experience in the qualification and validation. Professional Qualifications:
• PhD Chemical Engineering (University of Mississippi, USA)
• MSc Chemical Engineering (University of Mississippi, USA)
• BSc Chemical Engineering (University of Florida, USA)
• BSc Chemistry (Chiang Mai University, Thailand)
Practical Quality Management and Data Integrity
Seminar
Tuesday 12th December 2017
Convention Hall C-D, Ambassador Hotel Bangkok, 171 Sukhumvit Soi 11, Bangkok 10110, Thailand
(BTS Nana Station Exit 3), http://www.amtel.co.th/
Dr. Sasivimol Kittivoravitkul
Dr. Sasivimol Kittivoravitkul is managing director of Advance Pharmaceutical manufacturing Co., Ltd.
(APm) with +10 years experienced in pharmaceutical industry.
Professional Qualifications:
• PhD Computer Science (Imperial College London, UK)
• MSc Computer Science (Imperial College London, UK)
• BSc Statistics (Chulalongkorn University, Thailand)
Practical Quality Management and Data Integrity
Seminar
Tuesday 12th December 2017
Convention Hall C-D, Ambassador Hotel Bangkok, 171 Sukhumvit Soi 11, Bangkok 10110, Thailand
(BTS Nana Station Exit 3), http://www.amtel.co.th/
Venue Information
Convention Hall C-D, Ambassador Hotel, Sukhumvit Soi 11
Schedule
Practical Quality Management and Data Integrity
Tuesday 12th December, 2017
08:30 – 09:00 Registration
09:00 – 09:15 Opening Remark
by Mr. Totsapon Santitewagun (ISPE Thailand President)
09:15 – 10:30 Regulatory Perspective on Data Integrity
by Dr. Suchart Chongprasert (Acting Director of Drug Control Bureau, Thai FDA)
Ms. Achiraya Praisuwan (GMP Inspector, Thai FDA)
10:30 – 11:00 Coffee Break
11:00 – 12:00 How to Implement a Quality Management System
by Dr. Anthony Margetts (ISPE Thailand Vice-President)
12:00 – 13:00 Lunch Break
13:00 – 14:30 Practical Data Integrity
• How to start
• What to do to manage data integrity in your company
• Data integrity in paper and electronic systems
Data Integrity Case Studies
by Dr. Anthony Margetts (ISPE Thailand Vice-President)
Practical Quality Management and Data Integrity
Seminar
Tuesday 12th December 2017
Convention Hall C-D, Ambassador Hotel Bangkok, 171 Sukhumvit Soi 11, Bangkok 10110, Thailand
(BTS Nana Station Exit 3), http://www.amtel.co.th/
14:30 – 15:00 Addressing Data Integrity across your organization
by Dr. Sasivimol Kittivoravitkul (ISPE Thailand Committee)
15:00 – 15:30 Coffee Break
15:30 – 17:00 Discussion Forum : Our challenges in establishing effective Quality Management
and Data Integrity system
Discussion Panel :
Dr. Suchart Chongprasert
Dr. Anthony Margetts
Dr. Anuchit Sekthira
Moderator : Dr. Sasivimol Kittivoravitkul
Registration Fees
Type Fee (Baht)
ISPE & TIPA Member 2,000
Non-Member 3,000
Remark: Seats are limited to 100 Attendees with first-come, first-served basis
Practical Quality Management and Data Integrity
Seminar
Tuesday 12th December 2017
Convention Hall C-D, Ambassador Hotel Bangkok, 171 Sukhumvit Soi 11, Bangkok 10110, Thailand
(BTS Nana Station Exit 3), http://www.amtel.co.th/
HOW TO REGISTER
1. Online Registration Browse website WWW.ISPETH.ORG/EVENT-4_2017, fill-in delegate details and click submit
2. Confirmation ISPE staff will confirm your registration status via email. If not receive email within 2 working days after submitted the form, please contact our staff.
3. Payment Make a payment to reserve your seats and capture/ scan transferred evidents i.e. payslip to email [email protected]
REGISTRATION CLOSES ON 8 DECEMBER 2017 OR WHEN ALL SEATS ARE FULLY RESERVED. FIND OUT MORE INFO & CONTACT US: WWW.ISPETH.ORG EMAIL: [email protected] T: +6688-090-4664
PAYMENT
Payment must be received with in 8 December 2017 otherwise the
reservation will be cancelled. All payments should be made in Thai Baht
BANK > KASIKORN BANK, LAD PRAO 67 BRANCH
ACCOUNT > ISPE FOUNDATION
NUMBER > 027-8-46566-7
SWIFT CODE > KASITHBK
BANK ADDRESS > 2347 LADPRAO 67, WANGTHONGLANG,
BANGKOK, THAILAND 10310
SUBSTITUTION / CANCELLATION
Substitute delegates are not
allowed. Cancellations must be
received in writing at least 10
business days before the start of
the event.
TERMS AND CONDITIONS
All fees stated include
luncheons, refreshments and
documentation. It does not
include the cost of
accommodation and travel.
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