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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

http://www.amtel.co.th/

https://www.techopedia.com/definition/27858/data-integrity-networking

http://www.techradar.com/us/news/world-of-tech/the-importance-of-big-data-analytics-in-business-1267606


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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.



Seminar




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)



Seminar




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)



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Venue Information

Convention Hall C-D, Ambassador Hotel, Sukhumvit Soi 11

Schedule


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)



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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



Seminar




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.


http://www.ispeth.org/EVENT-4_2017

mailto:[email protected]

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