ISPE Thailand Affiliate Past Events

ISPE Thailand 15th Anniversary Annual Meeting 2018
Quality beyond Compliance

Date: 16th - 18th July 2018
Venue:Ambassador Hotel Bangkok, 171 Sukhumvit Soi 11, Bangkok 10110, Thailand
(BTS Nana Station Exit 3),

Flyer & Registration:
Flyer (English)
Flyer (Thai)
Speaker List

ISPE Thailand Student Membership Information

Documents for Download:
Information Flyer
Application Form
Poster Competition

ISPE Thailand 1st Seminar/Workshop Year 2018

Track 1:
Applied Risk Management for Commissioning & Qualification
Speaker: Pierre Winnepenninckx
Track 2: Changes to the PIC/S GMP guidance on the manufacture of sterile medicines (Annex 1)
Speaker: Gordon J. Farquharson

Date: 12th – 13rd February 2018
Venue:Ambassador Hotel Bangkok, 171 Sukhumvit Soi 11, Bangkok 10110, Thailand
(BTS Nana Station Exit 3),

Flyer & Registration:
Flyer (English)
Flyer (Thai)

Practical Quality Management and Data Integrity Seminar
 Tuesday 12th December 2017
Venue: Convention Hall C-D, Ambassador Hotel Bangkok, 171 Sukhumvit Soi 11, Bangkok 10110, Thailand
(BTS Nana Station Exit 3),

Flyer & Registration:

“Energy Complex (ENCO)”
 November 24 2017, 09.00-12.00AM
Venue: 555/1 Vibhavadi Rangsit Road, Bangkok 10900

Flyer & Registration:

“Cleaning Validation Theory and Practice”
 16-17 October, 2017
Venue: Ambassador Hotel Bangkok

Maurice Parlane

Agenda & Registration:

"Pharmaceutical Manufacturing Facility For The Future"

Date: 16-18 August 2017, Ambassador Hotel Bangkok, Thailand

>> Download Agenda Flyer for Thai resident
>> Download Agenda Flyer for Non Thai resident package

EARLY BIRD AND GROUP RATE ARE AVAILABLE, Register now to get discounts!

Online Registration at

(Registration closes on 12 August 2017 or when all seats are fully reserved.)

Track 1 Track 2 Track 3

HVAC Environmental Control Principles – best practices for GMP compliance
Gordon Farquharson, Critical Systems Ltd.

Cleanroom Behavior
The course provides an essential introduction to cleanrooms and to cleanroom behaviour
Philip Vanbeek

Modern OSD factory design: Vertical and horizontal flows, closed system and containment
Don Grubb, Rieckermann Engineering Operations

CASE STUDY: OSD Project in Vietnam
Shigehiro Tahara, PT. CMPlus Consulting Indonesia

OSD Process Improvement using Intermediate Bulk Containers (IBCs)
David Newell, Matcon Group Limited

Track 4 Track 5 Track 6

Pharmaceutical Water Systems – Essential features and practice GMP facilities
Gordon Farquharson, Critical Systems Ltd.

Cleanroom Behavior
The course provides an essential introduction to cleanrooms and to cleanroom behaviour
Philip Vanbeek

Process Design and Scale Up methods - Relevance of Hot Melt Extrusion and Twin Screw Granulation
Dr. Ansgar Frendel, Thermo Fisher Scientific

Manufacturing Processes - New Technologies & Trends
Dr. B. Düthorn, Bosch Packaging, Technology GmbH, Germany and J. Lim, Bosch, Bosch Packaging Technology, Singapore


Join ISPE Japan Annual Conference and Plant Visit

Exclusive, for ISPE member only Date: 16-20 May, 2017

Venue: 16 May: Plant Tour in Toyama, 18-19 May: Annual Meeting at Toyama International Conference Center, 20 May: Optional for local tour visit at Alpen

More information: Click here

“Cleanroom Testing & Certification ”
 2-3 May 2017
Venue: Ambassador Hotel Bangkok

Speaker: Dan C. Milholland

Agenda & Registration: Click here

“GMP Pharmaceutical Facility Design”
 Thursday 16th February 2017
Venue: Ambassador Hotel Bangkok

Speaker: Prof. Leonid Shnayder, Alain Kupferman and Miss Patchareewan Phungnil from Thai FDA

Moderator: Miss Danurus Wattanavekin and Miss Mukdavan Prakobvaitayakit

Presentation slide: Click here



“Data Integrity”
 Tuesday 18th October 2016
Venue: Mandarin Hotel Bangkok

Speaker: Ms.Charlie Wakeham

Moderator: Prasert Lertlerphunt

Workshop Answers: Click here

After completing Data Integrity seminar presented by Ms.Charlie Wakeham, feedback had been great with almost 300 attendees. The Attendees understood precisely on drug manufacturing. Using the high quality data for assessment is an important factor basis on either papers or electronic documents. Data Integrity is a platform from starting process until the end of production such as recording, operating, data storage, quality control and deleting the data. Nowadays, Data Integrity becomes a primary concern for PIC/S GMP inspectors.

"Update on HVAC and Critical Utilities for Pharmaceutical Industry"
 29th - 30th August 2016
Venue:Convention C-D, 1st Floor, Ambassador Hotel Bangkok

Speaker: Mr. Gordon Farquharson and Dr. Anthony Margetts

Moderator : Mr. Totsapon Santitewagun and Mr. Weerayut Chirarutsami

Attendee job function Pharmaceutical Industry: 
Engineer ,QA, QC, Production and Validation, R&D, RA

The event was very successful due to a large number for attendees which is more than 200 from pharmaceutical industry. We also received a very positive feedback from them.
The meeting objectives are to inform and understand commission qualification maintenance and the HVAC system principals. We concentrated on the new regulations of clean room under ISO 14644-1&14644-2(2015). Besides, GMP the EU&PIC/S Annex11 is expected to update the new version under ISO 14644 recently. We were also concerned on the new Ph EUR WFI monograph and specification for air quality. Therefore attendees could figure out clearer about commissioning qualification maintenance of compressed air. They had learnt Building Automation System (BAS) technology by exclusive speakers.

Click here to download Full Presentations: "HVAC Slide on 29-30 August 2016 "

“PIC/S Requirements for Quality Management”
 Wednesday 7th October 2015
Venue:Convention C, 1st Floor, Ambassador Hotel Bangkok

Who should attend:
Pharmaceutical Industry Owners and Management. Quality Management is an important responsibility for the management team, all managers should attend.

Mrs. Helena Baião

Further information: Agenda and Registration Form

“Preparing for the new PIC/s GMP Annex 15”
Process Development, Process Validation and QbD - How to Manage the Requirements of the New EU/PICS Annex 15

 Tuesday 26th - Wednesday 27th May 2015
Venue: Ambassador Hotel Bangkok

Background and objective:
Here in Asian Region we have to follow PICS regulations, EU /PICS annex 15 states the following:

Process Validation should be based on documented critical process parameters (CPP’s) and critical quality attributes (CQA’s) as a result of risk assessment activities as applicable. If a design space justification is used, the process knowledge and statistics used to confirm a state of control should be available. Validation batches (including continuous process verification) that are released to the market should fully comply with GMP & Marketing Authorisation and meet all validation acceptance criteria.

What do companies need to do to comply with this?

• What companies need to know, overview including regulatory review USA, EU, Asian, and requirements of new PICS GMP Annex 15 for process validation
• Process understanding, CQA, CPP
• Development of acceptable operation range
• Required statistical processes
• Practical application of the ideas-Case Study on generic product
• Review of past records to determine CPP-Case Study (focus)
• Can Continuous Process Verification be developed for existing products?
• Company organization required
• Benefits

Mr. Bikash Chatterjee, Project Executive, Pharmatech Associates, Inc.

Further information: Agenda and Registration Form

ASEAN Life Sciences Conference and Exhibition 2013
The Future of Life Sciences is Here!

 17th - 19th July 2013

Click here to download Full Presentations or Download each topic (Below) seperately

Conference Presentations


Key Note Speech 1: Role of ISPE in the region
Speaker: Dr. Charlotte Enghave Fruergaard, Chairman of the ISPE International Board of Directors


Manufacturing technologies & tools from laboratory to manufacturing
Speaker: Ms. Deborah R Cohen , GE Healthcare Life Sciences


Preassembled facility : an off-the-shelf solution to the  biomanufacturing needs
Speaker: Mr.Nihir Parikh, GE Healthcare Life Sciences


Sterile technology (Restricted Access Barrier System (RABS) and Isolator)
Speaker: Dr. Charlotte Enghave Fruergaard, NNE Pharmaplan


Critical Utility Design and Maintenance
Speaker: Mr. Gaston Loo, MSD Singapore


Key Aspects of Comprehensive Calibration and Maintenance Management System (CMMS) Implementation
Speaker: Mr. Tantra Tantraporn, Grand Thornton


Project Management for Pharmaceutical Production Facilities
Speaker: Mr. Harald Geitz ,io-consultants


Factory Design
Speaker: Alain Kupferman


The role of Manufacturing IT - An Integrated Approach (ERP)
Speaker: Mr. Prateep Juavijitjan, Microsoft Partner (Vantage Business Solutions (Thailand) Co.,Ltd.)


The role of Manufacturing IT - An Integrated Approach (MES)
Speaker: Mr. Florian Seitz, Werum Software & Systems AG


The role of Manufacturing IT - An Integrated Approach (LIMS)
Speaker: Mr. Michael Wang, Accelrys, Inc.


The role of Manufacturing IT - An Integrated Approach (eQMS)
Speaker: Mr. David Margetts, Factorytalk Co., Ltd.


Quality by Design (QbD) and Process Analytical Technology (PAT)
Speaker: Mr. Bikash Chatterjee, Pharmatech Associates, USA

“Good Engineering Practice (GEP)”

 Thursday 26th - Friday 27th July 2012
Venue: Arnoma Hotel, Bangkok

The use of "Good engineering practice" is good practice for managing pharmaceutical industry projects and will reduce time and resources spent on qualification and validation. This event will be two day seminar which will be focused on following:

  • Applicable Regulations
  • Risk Management
  • Practical application of science and risk based approach to process and system equipment verification
  • Making best use of supplier documentation
  • Practical approach to documentation and document approvals
  • Change management and how to gain acceptance of this
  • Opportunity to take part in group exercises to use tools in real life examples

Further information: Agenda and Registration Form

SPECIAL: Group Registration Package - Register from 3 persons onwards receive 300 Baht discount (before VAT) per person!


 24 February 2012
*Please ensure to arrive at least 10 – 15 minutes before 8.30am

Bangkok Lab and Cosmetics Co., Ltd use the latest technology in its production
line and continually pursue new research and development in order to bring novel
higher-quality products to the market. Its factory is accredited with a Good
Manufacturing Practice (GMP) Certificate, which is the highest standard issued by
the Food and Drug Administration (FDA) of Thailand's Ministry of Public Health, for
every product that it manufactures. It is also certified to meet the standards of ISO
9001:2008, ISO 14001:2004, OHSAS 18001:2007, and TLS 8001:2003.

Session 1: Production Area Session 2: QC Area

Further information: Agenda and Registration Form

ISPE Thailand Annual Meeting 2011
“Basic Concept in developing URS for pharmaceutical water system”

 26 August 2011
Time: 9.00 - 16.30
Place: Ground Floor, Convention Hall C , The Ambassador Hotel, Bangkok

Background and Objective:
The event will be one day seminar which has a live demonstratio n. The objective of this seminar is to instill a good engineering practice in pharmaceutical water system design to the pharmaceutical industry in Thailand.

Participants are expected to learn and apply the following concepts:
1) Specifications of pharmaceutical water system in accordance to EU and USP
2) Zero dead leg, surface entrapments and drainability concepts
3) Ozone sanitization
4) Generation and storage system design
5) Distribution (piping and looping) & POU design
6) Orbital welding
7) Low-cost low-energy CIP&SIP design

Further information: Agenda and Registration Form

The ISPE Thailand Affiliate’s workshop on “A practical approach to assessment and control of cross contamination in multi product OSD plants” was held on 11-12July 2011 at The Ambassador Hotel, Bangkok. 

Mr. Gordon Farquharson, ISPE Certified Trainer, was invited by the Affiliate to be a main instructor working together with Dr. Tony Margetts for this workshop.

The two day events attracted a total of 60 participants, mainly from pharmaceutical companies, industry vendors, universities and also regulatory. Starting the day 1 with the session from Thai FDA, Mr. Damrong Thitikornkovit, currently working as a head of inspector s. He updated us on the current status of PIC/S in Thailand and the Thai FDA expectation on cross contamination.  Then continue with Mr. Gordon lectures on Cross Contamination Risk Assessments.

Participants were divided into working groups and contributed actively during the workshop session covering risk identification, risk prioritization and risk control (mitigation), as well as learning how to Identify occupational health and safety risks and control measures. The workshop continued to Day 2 with supported by Mr. Gordon, Dr. Tony and Ms. Linda. At the end each group presented what they learnt from the workshop.

The survey completed by the participants showed that they found the course very useful and the overall quality of instruction was very good

For more information on Thailand Affiliate and our activities, please visit or contact Ms. Oracha Arthithanukati,


PLANT TOUR: Unison Laboratories Co., Ltd.

Date: 25 February 2010
Time: 8.30 - 16.00
Meeting Point: Tesco Lotus – Ramintra ( next to Homepro)
* Please ensure to arrive at least 10 – 15 minutes before 8.30am

This coming plant Tour, Unison Laboratories Co., Ltd. gives us an opportunity to visit the factory at Chachoengsao, which will allow us to have a very close experience on HVAC/ BAS and Purified water plant and QC lab and liquid production plant.

Plant Tour Activities:
Session 1: HVAC/ BAS and Purified water plant
Session 2: QC lab and liquid production plant

Delivering Compliant and Cost Effective Pharmaceutical Projects in South East Asia
An Oral Solid Dose Case Study

Date: 18-19 October 2010
Time: 9.00 - 16.30
Place: 6th Floor, Kamonmart Room, Siam City Hotel, Bangkok

The seminar will focus on case studies on manufacture of oral solid forms with Low to Moderate Active Pharmaceutical Ingredients. This type of plant is probably the most common in Thailand and a number of companies are planning to build new plants. A practical course for 2 days to provide information for design companies, contracting companies, construction companies and owners and engineers from pharmaceutical companies about how to run a project to build a new oral solid dose (OSD) facility to meet PICS regulations and to use industry best practice (based on ISPE publications)

Managers and Engineers from Pharmaceutical Companies
Managers and Engineers from Design and contracting Companies

Further information: Agenda, Registration Form

ISPE Thailand Annual Meeting 2010

Date: Thursday, 15 July 2010
Time: 11:30 – 16:30
Place: The Montien City Hotel, Surawong Road

The 2010 Annual Meeting will consist of informative seminar sessions and the internal meeting for ISPE Member. We would like to ask you to help us to STAY-IN-TOUCH with you by completing your current information in the Attendance Form if you are able to join or not, and return back to us the completed Form until 1 July 2010

Seminar Session 1:
An overview perspective of Renovating/ Building new Facility Experience

Presented by: Ms. Jittaporn Wattanaseree, Bionet-Asia Co., Ltd.

Seminar Session 2:
How to deal with Annual Review, Deviation Report for Utilities Systems

Presented by: Mr. Thamdol Khampiranont, GPO-Merieux Biological Products Co, Ltd.

For reservation or further details, please click on: Agenda and Registration Form

Workshop - "Facility Design & Operation for Compliant Pharmaceutical Manufacture"
May 19, 2010

Presented by: Mr. Gordon Farquharson , Critical Systems Ltd.
Venue: The Montien Hotel, Bangkok

A number of Pharmaceutical Companies here in Thailand are planning new facilities or refurbishment projects. New facilities are normally provided by construction firms as turn-key projects. This involves delivery of management, design, construction, installation and commissioning services. It is therefore timely to keep up to date with best practice, new requirements and industry trends.

This one day seminar will cover the following principles and important topics:-

  • Recent GMP requirements
  • Energy saving & sustainability considerations workshop---is there a conflict with our GMPs?
  • Containment and segregation.

Participants will be limited to 40 persons to ensure practical interactions

To find more details on the seminar: Agenda & Registration Form

ISPE Thailand Upcoming Workshop: "PIC/S Update - Draft Annex 11 Computerized Systems"
August 21, 2009, The Ambassder Hotel

Presented by: Dr. Anthony Margetts, Good Automated Manufacturing Practice editor

The updated Annex11 of the EU GMP will also be the PIC/S standard. Companies currently supplying to or intending to supply PIC/S markets or the EU should be aware of and determine their approach in meeting the regulations. Responsible staff from Companies’ Production and QA departments should understand the benefits these regulations can bring and IT departments will need to review and align their procedures and processes.

The event will include several workshop sessions to help understanding. The sessions will be interactive and will also discuss practical case studies.

To find more details on the seminar: Agenda & Registration Form

ISPE Thailand Annual Meeting 2009: Water Systems
March 31, 2009, Miracle Grand Hotel

The 2009 Annual Meeting will consist of informative seminar sessions and the election of a new President and Vice President. We would like to ask you to state your willingness in being part of the vote for the ISPE Thailand Board 2009 in the attached Form. The main responsibilities of the ISPE Thailand Board is to coordinate the overall Affiliate planning and management of the various activities and events.

ISPE Member Registration: Agenda & Registration Form,
Non-ISPE Member Registration: Agenda & Registration Form

Furthur Information: Roles and Responsibilities of ISPE Board

Presentation: Chirst Qualification, FDA
Photo: image1, image2, image3, image 4

Workshop - "Risk Based Approach to Managing Deviations and Quality Incidents"
February 3, 2009, The Ambassder Hotel

Presented by: Ms. Linda Ambrose, Ambrose Consulting Ltd.

This highly interactive workshop will provide participants with the practical skills necessary to manage quality incidents and deviations using a risk based approach.  Participants are invited to bring examples of incidents or deviation as case studies to discuss in the workshop.

To find more details on the seminar: Agenda & Registration Form

1. Where do product come from
2. Deviation Reporting
3. Quality Incident Impact Assessment Practice
4. Quality Incidents examples
5. Doing Risk Assessment
6. Simple Risk Analysis Record
7. CAPA & Root Cause Analysis
8. CAPA form

Photo: Image1, Image2, Image 3, Image4

Seminar - " How to handle out of specification and deviation"
November, 2008 (TBA)

Presented by: Ms. Linda Ambrose, Ambrose Counsulting Co. Ltd.

Seminar - "GMP Requirements for Equipment and Metal Pretreatment for Pharmaceutical Industry "
October 22, 2008
, Mahidol University, Faculty of Pharmacy (Map)
Presented by: Mr. Peerayoot  Pimhataivoot, NR Industries Company Limited
                      Mr. Pichet Cheepsujjayan, Johnson’s Laboratories Co., Ltd.

To find more details on the seminar: Agenda & Registration Form

GMP Requirements for Equipment By Mr. Peerayoot : Part 1-2
Metal Pretreatment for Pharmaceutical Industry By Mr. Pichet : Part 1, Part 2

Example URS (User Requirements Specifications):
JETT-BlankURS, JETT-TabletCoaterURS
Photos: image1, image2, image3, image4, image5

Seminar - "Reaching US FDA GMP standards with Information Technology"
September 29, 2008
, Pathumwan Princess Hotel
Sponsored by: ISS Consulting (Thailand) Co., Ltd.
Presented by: Mr.Teerapong Cheepchol, Factorytalk Co., Ltd.
                     (supported by Dr. Tony Margetts, GAMP editor)
                     Mr. Noradash Jirasatitvorakul, ISS Consulting (Thailand) Ltd.

To find more details on the seminar: Agenda & Registration Form

Seminar Presentation to download: Compliance and Information Technology, Computer Systems Validation
Photo: image 1, image 2, image 3, image 4, image 5

Seminar - "HVAC for non sterile and sterile products"
July 24-25, 2008
Richmond Hotel (Map)

Presented by: Mr. Gordon Farquharson, Bovis Lend Lease Co., Ltd.

" Great successes on our last seminar with over 400 attendees consist of 147 companies, 2 universities and 22 sponsors. Mr. Gordon Farquharson, Principal Consultant at Bovis Lend Lease gave a very great presentation on "HVAC for non-sterile and sterile products". He stressed Requirements for non-sterile and sterile products and he also covered 3 case studies into his presentation. "

For more details, please click on the following links:
Visitor's Agenda, Sponsor's List, Case Studies

Mr. Gordon Presentation (10.4 MB)
Photo: image1, image2, image3, image4

ISPE Thailand Annual Meeting 2008
March 19, 2008
Sheraton Grande Sukhumvit Hotel

For more details, please click on the following links:
Agenda, Minute of meeting

Please help us to find the ISPE Thailand President and Vice-president 2008 by clicking a link below and nominate 2 members, when finished, click “send email” button.
Nomination Form, Reponsibility of ISPE Thailand Board

ISPE and PIC/S Present an Interactive Workshop
“Systems Approach to Quality Risk Management”
November 22-23, 2007

Grand Copthorne Waterfront Hotel

Members who reside in emerging economy country (including Thailand) are eligible for the 50% discount on the current registration fee.  

Member Fees

 Current Fee

Emerging Economy Fee

Member Fee (before 8 October)



Member Fee (after 8 October)



For more details, please click on the following links:
PICS-ISPE workshops, Agenda, Registration Form, Hotel Reservation , Delegate Form

Workshop - Preparing for a PIC/S GMP inspection
October 5, 2007
Presented by: Linda Ambrose, Factorytalk

Get details on PIC/S GMP regulatory perspectives, knowledge of best practices through active participation in discussions - with an opportunity to determine and prioritize topics.

For more details, please click on the following links:

Pictures Image1, Image2, Image3

Seminar -New Trends in Pharmaceutical Manufacturing: PAT
September 7, 2007
Pan Pacific Hotel
Presented by: Dr. Helmut Berg, Bayer Technology and Engineering (Shanghai) Co., Ltd.

For more details, please click on the following links:
Pictures: Seminar1, Seminar2

Seminar - Overview of Process Control System and Manufacturing, Automation
August 3, 2007

Presented by: Chatchai Wajakiet, Rockwell Automation

ISPE Dinner Meeting
March 9, 2007

After a great dinner at The Siam City Hotel, Ms. Linda Ambrose, Senior Consultant at Factorytalk Co., Ltd. presented a very interested topic among the Thai pharmaceutical manufacturers: “PIC/S GMP What is the implication for Thai Pharmaceutical Manufacturers?” Over 20 pharmaceutical manufacturers participated in this event.  The warm welcome atmosphere plus the good food brought all the participants together as one in the election of the President and Vice President for ISPE Thailand Affiliate Board 2007.  Majority vote went to Mr. Chartchai Wajakiet as President and Mr. Bernhard Thurnbauer as Vice President.

For more details, please click on the following links:
Agenda, Minutes of Meeting
Pictures: image1, image2, image3

R.X. Manufacturing Plant Tour
February 2, 2007

76 Moo 10 Tumbon Narapirom
Amphur Banglane Nakornpathom 73130
Tel. (034) 298117-21

For more details click on the following link:

Training Course
AP Congress

ISPE/TPMA Seminar:
“PIC/S—Requirements for Films/Foils for Pharmaceutical Use,” 6 Nov.

Erwin Pasbrig, PhD, director R&D at Alcan Packaging Pharmaceutical Europe and USA, presented to 60 participants on PIC/S regulatory requirements for packaging material such as foils.  He stressed the PIC/S requirements for blister materials and foils requirements from a development perspective and in pharmaceutical manufacturing.  He also covered the anti counterfeiting features on primary packaging materials: overt and covert features and the different security levels.

For mor details on the event please click on the following links:
Seminar agenda
Pictures : Image to ISPE AP1, Image to ISPE AP2
1/2 day Seminar
Thai Pharmaceutical Exhibition
Thursday 14th September 2006
Swissotel Le Concord Hotel, Bangkok.

For more details on the event please click on the following links:
TPE (Thai Pharma Exhibition) Swiss Hotel Floor Plan TPE 2006

Workshop GMPs
Singapore Conference
Training Course
Group to Achema
India Conference APIs and Q7A
Education Workshop cGMP
Japan Conference
Training Course
Training Course Biotech
Workshop GMPs
Training Course C&Q
Educational Workshop cGMP
Seminar Good Design Pratices for PIC/S GMP Pharmaceutical Facilities