Secretariat ISPE Indonesia Affiliate Jl Martimbang 22B, kebayoran Baru, Jakarta Selatan 12120. T : +62 21 7224 590 F: +62 21 7222 043 E : secretariat.ispeind@gmail.com, hp: 0813-8734-5158

www.ispe.org Jakarta, 10 Agustus 2012

No : 013A/ISPEIND-VIII/12 Re : Workshop "Analytical Method Validation

In order to continuously share up-date information to the pharmaceutical industry, ISPE Indonesia Affiliate will hold workshop for professionals in the industry, especially in Quality Control and Analytical Development Laboratory on : :

"ANALYTICAL METHOD VALIDATION. Date : 18 dan 19 September 2012 Time : 08.00 17.00 wib. Place : Hotel Acacia Jl. Kramat Raya N0.81

Jakarta 10450 Analytical method is an important procedure for realease of material before being used for manufactured, release of products before sale, stability study/tests and support various validation works such as process and cleaning validation. Therefore it is important to validate the analytical method to confirm the suitability for intended purpose.. Durin the workshop there will presentation of various material including introduction, test parameters for various analytical methods including HPLC, spektrophotometry and other tests method/techniques, microbioligical and documentation needed to do the validation. Participants will also have the chance to theoretically implement through group discussion/study and for this purpose it is required to bring along laptop on day 2. This workshop will be lead by professional in their area, among others Mr. Joseph Talpaneni (R&D Analytical Method Development from Dexa Group), Iin Susanti from Biofarma and speakers from ISPE Indonesia Affiliate. Fee for the workshop is Rp. 1.500.00 for ISPE members and Rp. 2.000.000,- for non members. Dead-line for confirmation and payment latest 14th September 2012 , transfered to ISPE Indonesia Affiliate account at BCA Fatmawati. No. 0713019060, no registration not payment will be accepted on site. Due to the case study activity in the workshop, participants will be limited and registration will be based on first register first served. Who has an interest to participate in this workshop can register by filling in the attached registration form and send to ISPE Indonesia Affiliate Secretariat by Fax. 021-7222043 together with payment.

Secretariat ISPE Indonesia Affiliate Jl Martimbang 22B, kebayoran Baru, Jakarta Selatan 12120. T : +62 21 7224 590 F: +62 21 7222 043 E : secretariat.ispeind@gmail.com, hp: 0813-8734-5158

ISPE member who register is not allowed to transfer to other participant ecpecially ro non-member. ISPE Indonesia Affiliate, M. Sumarno Education Program Director

Secretariat ISPE Indonesia Affiliate Jl Martimbang 22B, kebayoran Baru, Jakarta Selatan 12120. T : +62 21 7224 590 F: +62 21 7222 043 E : secretariat.ispeind@gmail.com, hp: 0813-8734-5158

www.ispe.org Workshop

on Analytical method Validation

Tentative Agenda Day I : 18 September 2012 : 8.00 9.00 Registration, morning break 9.00 9.15 Opening 9.15 10.45 Introduction to Analytical Methode Validation 10:45 12.30 Test parameters and acceptance criteria 12:30 13:30 Lunch 13:30 15.00 Test parameter and acceptance criteria 15:00 - 15:30 Coffee break 15:30 16:45 Analytical method validation for Mikrobiological method 16:45 17:10 Grouping Day II : 19 September 2012 : 9.00 10.00 Documentation 10.00 12.00 Goup discussion 12:00 13:00 Lunch 13:00 14.30 Group presentation 14.30 - 15:00 Coffee break 15.00 16.00 Group presentasi 16:00 16:30 Q&A and closing

Secretariat ISPE Indonesia Affiliate Jl Martimbang 22B, kebayoran Baru, Jakarta Selatan 12120. T : +62 21 7224 590 F: +62 21 7222 043 E : secretariat.ispeind@gmail.com, hp: 0813-8734-5158

Workshop on : "Analytical Methode Validation Date: 18-19 September 2012

REGISTRATION FORM (attach payment slip and fax to ISPE Indonesia Affiliate secretariat) Company

Address

Phone & Fax no.

Telp..........................................Fax......................................

Participant Name & Title

1. Name ............................................. Title ............................................. ISPE member ID : ........................................ Email : ........................................

2. Name ............................................. Title ............................................. ISPE member ID : ........................................ Email : ........................................

Send to : ISPE Indonesia Affiliate Secretariat, Fax no. +62 21 7222043, attach the payment evidence Rp 1.500.000/participant for ISPE member and Rp 2.000.000/participant for non member, limited seats and no on-site payment. Payment to be transferred to ISPE Indonesia Affiliate account at BCA Fatmawati no . 0713019060 Jakarta, .............................. Participant (.......................................)

REGISTRATION FORM