Seminar Agenda

Organised by
Intern. Society for Pharm. Engineering (ISPE) Thailand

&
Thai Pharmaceutical Manufactures Association (TPMA)
WORKSHOP:
“An Oral Solid Dosage Plant Design”
Monday 18th – Tuesday 19th October 2010, Siam City Hotel, Bangkok
BACKGROUND AND OBJECTIVE

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)
AGENDA
This two day seminar will cover the following principles and important topics:-
 Project Management - Customer and Supplier relationships – responsibilities and activities of the
pharmaceutical company and responsibilities and activities provided by the design companies,
contracting companies, construction companies.
 The Vision - Case studies describe what a suitable plant might look like based on a typical OSD
process consisting of : dispense, wet granulation, fluid bed drying, compression,
 User requirements - Developing the key user requirements for the plant to meet production and
regulatory requirements covering the product/process, room/facility & systems, including
contamination control, critical utilities, processing equipment and control systems.
 Risk Assessment - Introduce the concept of system impact to manage qualification
 The Design Phase - Design Reviews – the importance of key design reviews leading to an
approved design. Examples of key design points covering the building, HVAC, critical utilities,
processing equipment and control systems.
 The Build phase – key points of build/install
 The Commissioning Phase – use of the correct documentation, concept of GEP, Testing, IQ,
OQ, PQ – what to test and record
 Handover - Final Reports, Ongoing Operation and Change control
The seminar includes Workshop sessions – to consolidate the design review process concentrating on the
facility and the utilities (HVAC) The workshop sessions are designed to provide practice with the important
management tools of:
 Project Management
 User Requirements Specification
 Design Review
 Risk Assessment
 Qualification and Validation
WHO SHOULD ATTEND

Managers and Engineers from Pharmaceutical Companies
Managers and Engineers from Design and Contracting Companies
ISPE Thailand Affiliate (Khun Oracha, Sutimarn)

Tel: 0-2630-4525 ext. 52, 55 | Fax: 0-2630-4527 | Email: [email protected]
Organised by
&
DAY 1
9:00 Start of morning session

Welcome and introductions
9:05
Keynote: Thailand perspective and opportunities for OSD manufacturing
– OSD Production in Thailand & Asean
– Importance of Regulations
Speaker: Mr. Paiboon Amatamahathana, Thai FDA
10:00 Coffee Break
10:30 Project Management: Good Practices for success and compliance of
pharmaceutical projects
– Project Framework (Customer & Supplier Responsibilities)
– User requirements
– Specification & Design Reviews
– Build phase
– Commissioning & qualification
– Project Documentation & Change Control
Speaker: Mr. Raymond Mikrut, Foster Wheeler
12:00 Lunch
13:00 Start of afternoon session
User Requirements Specification: Case study (Facilities & Utilities)
– The process & capacity
– The building
– Contamination control
– Environmental conditions
– Critical utilities
– Regulatory requirements
Speakers: Dr. Anthony Margetts, Factorytalk co.,ltd.
Mr. Mark Tang
Mr. Totsapol Santitewagun, Globaltech co.,ltd.
14:30 Coffee Break
Start (resume main conference) Good Practice for GMP: Update and
15:00 clarifications for OSD manufacturing
– GMP aspects of Facility Design
– Practical Points for Facility compliance and Project compliance
– Microbiology
Speaker: Ms. Linda Ambrose, Ambrose Consulting Ltd.
16:30 Closure

Organised by
&
DAY 2
9:00 Design Review Workshop: Design Review Workshop:

Track 1 - Facilities Track 2: HVAC
– Facility case study and information – HVAC case study and information
– Design review in groups – Design review in groups
– Group Feedback – Group Feedback
Trainer: Foster Wheeler Trainer: Dr. Anthony, Mr. Mark and
Mr. Totsapol
10:20 Coffee Break
10:40 Cont. Cont.
11:30 Lunch
12:30 Design Review Workshop: Summary of findings and main points
(Expert panel discussion)
13:00 Risk Assessment Workshop: Optimizing the effort of compliance
(Expert panel discussion)
– Risk framework
– Impact assessment
– Critical parameters
– Risk review as part of Design reviews
– Examples
Speaker: Dr. Anthony Margetts, Factorytalk
14:30 Coffee Break
15:00 Validation: A framework for project and compliance control
– Specification and verification
– Risk Assessment & Design reviews
– Good Engineering Practice
– Commissioning & qualification
– Testing – what to test and record
Speaker: Dr. Anthony Margetts, Factorytalk
16:30 Closure

Organised by
&
RESERVATION:
“An Oral Solid Dosage Plant Design”
Monday 18th – Tuesday 19th October 2010, Siam City Hotel, Bangkok
VENUE: 6th Floor, Kamonmart Room, Siam City Hotel:

477 Si Ayuthaya Road, Bangkok 10400: www.siamhotels.com - BTS: Phayathai Station
FEES: The fee is due upon reservation and includes seminar documentation, lunch and coffee breaks.
(Prices INCLUDE VAT 7%) - No Deduction of Withholding Tax.
ISPE Member 4,815 Baht/ delegate
Non-ISPE Member 5,885 Baht/ delegate
HOW TO RESERVE: Seats are limited: First-come-first-serve-basis

STEP 1 STEP 2 STEP 3 STEP 4
FILL-IN PAYMENT SUBMIT CONFIRM
Fill-in the attached Transfer to: Submit your reservation ISPE Thailand will confirm
reservation form with Siam Commercial Bank, form along with bank slip or the received of our
your details Branch: Samyaek Faichai a copy of cheque reservation to the given
Account Current contact person to ensure
Email to: that your seat is reserved.
Account Name: [email protected]
Thai Pharmaceutical or fax to: 02-630-4527
Manufacturers Association
Account Number: LATEST BY MONDAY,
036-2-64381-1 OCTOBER 11TH, 2010
SEMINAR SPEAKERS:
MR. RAYMOND MIKRUT - Project Manager for Foster Wheeler
Raymond Mikrut involved in Project Management since 1983 after graduating from college. Raymond Mikrut has
specialized in Pharmaceutical/Biotech project implementation since 1991. He has a strong understanding of the overall
project management approach together with overall regulatory requirements for pharmaceutical projects.
MR. SOON ENG GUAN - Section head, Pharmaceutical Process Engineering, Foster Wheeler
He has more than 12 years of experience in the Pharmaceutical industry, with the first 7 years spent in the USA
pharmaceutical contract manufacturing as a chemist/ Process engineer involved in cytotoxic product and vaccine in
fill/finish facilities.
DR. TONY MARGETTS - Associate Consultant, Factorytalk Co., Ltd.
Dr. Tony Margetts has more than 20 years in Pharmaceutical Manufacturing Industry. Dr Tony Margetts recently re-
located to South East Asia and operates as an Associate Consultant for Factorytalk Co., Ltd.
His experiences include leading teams for new product introductions including medical devices, gaining FDA pre-
approval inspection of manufacturing sites and he is also Chairman of editorial team for GAMP 5
MR. MARK TANG - Managing Director, Telstar Solutions (Thailand) Co., Ltd.
His technical positions are the Head of Regulatory Affairs (Thai FDA) and cGMP Specialist and Project Scientist for
Pharmaceutical Projects. Previously, at M+W (Thailand) Ltd. in Bangkok, Thailand, his last management position was the
Operations Manager, Projects Director and Head of Business Development. His technical positions are the Head of
Regulatory Affairs (Thai FDA) and cGMP Specialist and Project Scientist for Pharmaceutical Projects.
Previously, at Alpha Therapeutic Corp./Grifols USA LLC/Baxter Inc. in Los Angeles, California U.S.A., my last
management position was the Project Manager and Senior Principal Scientist for Alpha-1 Anti-Trypsin (AAT)
(Aralastâ). His technical positions were in Pharmaceutical (GMP) Manufacturing /Validation/ Quality Project
Management, R & D and QC Laboratory (GLP) Management, Regulatory Affairs (U.S. FDA) Technical Correspondence
and Pre-Approval Inspection.

Seminar Agenda

Uploaded by

Copyright:

Available Formats

Seminar Agenda

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Seminar Agenda

Uploaded by

Copyright:

Available Formats

Organised by

Intern. Society for Pharm. Engineering (ISPE) Thailand

BACKGROUND AND OBJECTIVE

WHO SHOULD ATTEND

ISPE Thailand Affiliate (Khun Oracha, Sutimarn)

9:00 Start of morning session

ISPE Thailand Affiliate (Khun Oracha, Sutimarn)

9:00 Design Review Workshop: Design Review Workshop:

ISPE Thailand Affiliate (Khun Oracha, Sutimarn)

VENUE: 6th Floor, Kamonmart Room, Siam City Hotel:

HOW TO RESERVE: Seats are limited: First-come-first-serve-basis

DR. TONY MARGETTS - Associate Consultant, Factorytalk Co., Ltd.

You might also like