ISPE ISPE ISPE

2014

ISPE ISPE ISPE ISPE ISPE

QUALITY BY DESIGN
Accredited by IAI

WHAT AND HOW TO START

ANNUAL CONFERENCE 6 th - 7 th M A Y , 2 0 1 4 GRAN MELIA HOTEL, JAKARTA

INDONESIA A F F I L I AT E

Its time to reconsider our way of thinking, its time to know, learn, decide and implement that Quality is not just a slogan and cannot only be tested into the product, but it must be built into product form the beginning. Now its time to implement QbD Quality by Design. QbD is defined as a systematic approach to developing products, that begins with predefined objectives and emphasises product and process understanding based on sound science and quality risk management . QbD implementation is a culture shift incorporating quality principles and function, stong risk compliance assessment and management at all stages of lifecycle from product development throughout distribution system and refocuses attention and resources on what is important to the customers i.e patients, health professionals, distribution chain. This conference will give an introduction in building Quality into product through implementation of QbD approach. the

ANNUAL CONFERENCE

SEAT
Strategic Quality Planning

LIMITED

Thinking About Quality Planning

Provide Measurement

SECRETARIAT
CONGRESS ORGANIZER/SECRETARIAT Medical Conference Organizer (MCO) By PT. Pharma-Pro International Ms. Jessica Perkantoran Duta Merlin block C / 35 37 Jl. Gajah Mada no 3 5 Jakarta 10130, Indonesia Phone : +6221-63869502, ext. 313 Fax : +6221-63869503/05 Mobile : +62812-3085-9682 (Jessica) Email : secretariat.ispeind@gmail.com : jessica@pharma-pro.com : wendy@pharma-pro.com Website : www.ispeindonesia.org MCO is certified by Indonesia Authority of MICE Industry and registered trademark of PT. Pharma-Pro International. This name is protected by Indonesia copyright laws

MultiFunctional Quality Planning

Pharma
Departmental Quality Planning Estabilish Quality Goals Develop Process Feature Develop Process Controls

QbD
Determine Customer Needs Identify Customers Develop Product Features

SPEAKERS
1. BOB TRIBE After having worked in the pharmaceutical industry in a senior Quality Assurance position, Bob Tribe joined the Therapeutic Goods Administration (TGA), Australia. He became Chief GMP Inspector in 1980, a position he held until his retirement in 2004. While at TGA he was elected Chairman of PIC/S in 2000-2001. After retiring from TGA he established Bob Tribe Consulting and has assisted many GMP regulatory authorities around the world reach the PIC/S level of regulatory control and consults to pharmaceutical manufacturers wishing to achieve compliance with PIC/S GMP requirements. Bob is a member of the WHO Expert Committee on Specifications for Pharmaceutical Preparations and undertakes GMP inspections for the WHO under its Pre-qualification Programme. He is also the ISPE Regulatory Affairs Advisor for the Asia-Pacific region. 2. LINDA AMBROSE Has worked in the pharmaceutical industry for almost 40 years during which time she has worked in Europe, USA & Asia in both large multinational companies as well as smaller generic companies. She has also managed the UK Medicines Inspectors and been a member of the PIC/S Executive Committee. Although shes been based in Asia for the last 10 years, Linda is also visiting lecturer in Advanced Pharmaceutical Sciences at the University of Manchester in the UK. With post graduate qualifications in business, psychology and the neuroscience of leadership, Linda is passionate to help her clients with operational improvement programmes, organisational development, team & individual staff development & training. She has a specialist interest in Organisational Psychology and using GMP & Quality Systems to benefit business strategy and in the development of QA & Technical staff.

REGISTRATION FORM
Seminar Fee ISPE Indonesia Affiliate Member : IDR 2.000.000 Non ISPE Indonesia Affiliate Member : IDR 3.000.000 Lecturer : IDR 1.000.000 Student : IDR 400.000 th Refundable 50% one week before May 6 , 2014 for cancellation Seminar Track Choice:
Plenary Session Track 1 Track 2 Please choose Track 1 or Track 2

Main Business :
Pharmaceutical Industry Other Pharmaceutical Related (Distributor, Pharmacy, etc) Suppliers and other pharmaceutical industry services Others

Please fill in with capital letters:

Please Complete Name: ISPE member, No. Non Member ISPE Company Department E-mail address

Day 1: 6th May 2014, 07.30 18.00 Registration

Plenary , All Participants Opening Welcome speech Keynote dan Pembukaan Increasing Influence of PIC/S in Asia Pacific Behavioural GMP

SESSION SCHEDULE

Track I : Product Design and Development QbD approach in Generic Product Development Implementation on Dossier Submission Guideline in Indonesia Designing Drug Delivery System and Dosage Form Manufacturing Facility Design : Manufacturing System, Facility, machine& equipment and critical utility

Track II : Supply Chain Design GMP in API manufacturer (ICH Q7) API auditing system and philosophy Mutual Responsibility and Relation between Industry and Supplier Outsourcing-Insourcing, what to be considered

Phone No. Fax No. Signature

Day 2 : 7th May 2014, 07.30 17.00 Registration

Track I : Process Design and Development Critical Process Parameter and Control Strategy determination Design of experiment and design space Analitycal method Development Container and closure system Development Bioequivalence test in product development, BE vs comparative dissolution Selection of comparator for equivalent assessment of interchangeable for multisource products (generic) Approvable letter Product Data base and Product audit Wrap-up and Closing Track II : Supply Chain Design QMS in raw material supplier and FG Distributor Development of robust /strong Supply chain system Selection of RM supplier related to product and process development Validation related to Supply Chain system (pre and post production) Vendor Selection Process, What to be considered Distributor Audit and evaluation Continuous Evaluation of API manufacturer and Supplier Wrap-up and Closing

Please transfer registration fee to:

ISPE Indonesia A/C No. 0713019060 Bank Central Asia (BCA) Fatmawati Branch Jl. Rs. Fatmawati No. 1CD

Please send registration form to:

PT Pharma Pro International PIC : Ms. Jessica (+62812-3085-9682) Phone : (021) 6386.9502 Fax : (021) 6386.9503/05 Email : secretariat.ispeind@gmail.com Jessica@pharma-pro.com wendy@pharma-pro.com Website : www.ispeindonesia.org

Please specify participants name/ company on the bank transfer receipt

Along with bank transfer receipt at the latest by 21 April 2014