ISPE

ISPEISPEISPE

ISPEISPEISPEISPE2014

ThinkingAboutQualityPlanning

Multi-FunctionalQualityPlanning

DevelopProcessFeature

DepartmentalQualityPlanning

DetermineCustomerNeeds

IdentifyCustomers

DevelopProductFeatures

DevelopProcessControls

StrategicQualityPlanning

ProvideMeasurement

EstabilishQualityGoals

Pharma

QbD

LIMITEDSEAT Accredited by IAI

A N N U A L C O N F E R E N C EIt’s time to reconsider our way of thinking, it’s 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 it’s 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 stong compliance function, risk assessment and management at all stages of product lifecycle from 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 the implementation of QbD approach.

“WHAT AND HOW TO START”

QUALITY BY DESIGN

SECRETARIAT

CONGRESS ORGANIZER/SECRETARIATMedical Conference Organizer (MCO®) ByPT. Pharma-Pro InternationalMs. JessicaPerkantoran Duta Merlin block C / 35 – 37Jl. Gajah Mada no 3 – 5 Jakarta 10130, IndonesiaPhone : +6221-63869502, ext. 313Fax : +6221-63869503/05Mobile : +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

A N N U A L C O N F E R E N C E6 t h - 7 t h M A Y , 2 0 1 4GRAN MELIA HOTEL, JAKARTA

A F F I L I A T EI N D O N E S I A

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 400.000Refundable 50% one week before May 6th, 2014 for cancellation

Seminar Track Choice: Plenary Session

Track 1

Track 2Please 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

Phone No.

Fax No.

Signature

ISPE IndonesiaA/C No. 0713019060Bank Central Asia (BCA)Fatmawati BranchJl. Rs. Fatmawati No. 1CD

PT Pharma – Pro InternationalPIC : Ms. Jessica (+62812-3085-9682)Phone : (021) 6386.9502Fax : (021) 6386.9503/05Email : secretariat.ispeind@gmail.com Jessica@pharma-pro.com wendy@pharma-pro.comWebsite : www.ispeindonesia.org Please specify participant’s name/

company on the bank transfer receipt

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

Please transfer registration fee to: Please send registration form to:

SPEAKERS

SESSION SCHEDULE

Day 2 : 7th May 2014, 07.30 – 17.00Registration

Wrap-up and Closing Wrap-up and Closing

• 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

• 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

Track I : Process Design and Development Track II : Supply Chain Design

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.

1. BOB TRIBE

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 she’s 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.

2. LINDA AMBROSE

Day 1: 6th May 2014, 07.30 – 18.00Registration

• Opening• Welcome speech• Keynote dan Pembukaan• Increasing Influence of PIC/S in Asia Pacific • Behavioural GMP

Plenary , All Participants

• 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

• 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

Track I : Product Design and Development Track II : Supply Chain Design