Date: Thursday, 15 July 2010
Time: 11:30 – 16:30
Place: The Montien City Hotel, Surawong Road
FREE OF CHARGE for ISPE Member

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

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

Presentation:
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 - "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

Presentation:
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

" 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

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

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:
Agenda

Pictures Image1, Image2, Image3

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:
Agenda

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 more details on the event please click on the following links:
TPE (Thai Pharma Exhibition)
Swiss Hotel Floor Plan TPE 2006
TPE PRICE LIST
OBJECTIVE July06