ISPE Indonesia

2015 ISPE Indonesia Annual Conference

When:
May 19, 2015 @ 8:00 am – May 20, 2015 @ 5:00 pm
2015-05-19T08:00:00+07:00
2015-05-20T17:00:00+07:00
Where:
Holiday Inn
Jalan Griya Utama No.1
Tanjung Priok, Kota Jakarta Utara, Daerah Khusus Ibukota Jakarta 14350
Indonesia

new ISPE 2015 - WEB-01
Maintaining Compliance through Effective and Efficient Operation
(Effective and Efficient Operation)

CONFERENCE HIGHLIGHTS

The  quality compliance is a challenge to pharmaceutical industry around the world and need continuous review and improvement considering the intended use of the medicinal product, which are life saving, restoring health and preserve health as well as enhancing quality of life.  Pharmaceutical industry should comply with the regulation and haphazard operation cannot be tolerated so do not place patients at risk and even fatal due to inadequate safety, quality or efficacy. This will need full commitment of the top management regarding compliance to  GMP and  regulation , review all systems and  compliance measurements.

However the compliance and all the subsequence efforts to achieve, are always perceived as high cost operation, especially in the era of tight competition in this decade. Therefore management should also be able to review their cost structure and implement effective and efficient operation without compromising quality, and understand that actually compliance effort is a quality cost reduction. Several ways to achieve this objective are among others, by applying LEAN concept with reliable & robust process and improve productivity across company.

This 2-days conference  will provide all participants with knowledge on compliance measures , review  and  plan  productivity improvement in operation as well as the importance of Management Review. 

 


IMPORTANT PROGRAM

  • Opening Ceremony & Keynote by Head of National Agency
    of Drug and Food Control of Republic of Indonesia

    Tuesday, 19th May 2015
  • Conference
    Tuesday & Wednesday, 19th & 20th May 2015
  • Exhibition
    Tuesday & Wednesday, 19th – 20th May 2015
  • Election of ISPE Indonesia Affiliate President
    Tuesday, 19th May 2015

SPEAKERS

 

Dra. Maura Linda Sitanggang, Ph.D
Director General of Pharmaceutical and Medical Devices Ministry of Health
Indonesia

 

Linda Ambrose
Head of Ambrose Consulting Ltd., Developing Quality Mindset, Thailand
United Kingdom

 

Shigehiro Tahara
Director of CM Plus Corporation
Japan

 

Wiwy Sasongko
IMS Helath Indonesia
Indonesia

Sayekti Sulisdiarto
Corporate Technical Advisor Mensa Group
Indonesia


 

Tentative Agenda (The schedule can be changed without notice)

ISPE INDONESIA AFFILIATE
ANNUAL CONFERENCE 2015

Managing Compliance Through Effective
And Efficient Operation
Holiday Inn, 19-20 May 2015

Day 1, May 19th, 2015
 08.00 – 08.45 Registration
Plenary
 08.45 – 09.40 Opening 
 09.40 – 10.10 Keynote (KaBadan POM)
Dr. Roy A Sparringa M.App. Sc., Head of National Agency of Drug and Food Control of Republic of Indonesia
 10.10 – 10.45 Break 
10.45 – 11.30 Improvement of Accessability of Quality Medicine for Universal Health Coverage
Dra. Linda Sitanggang, Ph.D., Director General of Pharmaceutical and Medical Devices, MOH of Republic of Indonesia 
 11.30 – 12.15 Current Indonesian Pharmaceutical Market Outlook
Wiwy Sasongko, IMS Health Indonesia 
 12.15 – 13.00 Regulatory Control Perspective on Pharmaceutical Industry Compliance
Dra. Togi J. Hutadjulu MHA.  DirectorProduction Control of  of Therapeutic Products and Household Products, NADFC 
13.00 – 14.00 Lunch
Breakout Session
Track 1
 14.00 – 14.45 Cost of Quality 
 14.45 – 15.30 Break 
 15.30 – 16.15 Quality Metric
Track 2  
 14.00 – 15.00 Lean Manufacturing
 15.00 – 15.45 Break 
 15.45 – 16.30 Lean Qualification
Shigehiro Tahara, Director of CM Plus Corporation, Japan 
 16.15 – 18.00 Election of ISPE Indonesia Affiliate President 
 
Day 2, May 20th, 2015
Breakout Session
Track 1
 09.00 – 09.45 Data Integrity
 09.45 – 10.15  eQMS
 10.30 – 11.00 Break
 11.00 – 11.45 GMDP (Good Manufacturing & Distribution Practice)
 11.45 – 12.30 Quality System Review
 12.30 – 13.30 Lunch
Track 2
 09.00 – 09.45 Value Stream
 09.45 – 10.30 TBD
 10.30 – 11.00 Break
 11.00 – 11.45 Energy Saving
 11.45 – 12.30 Productivity Improvement through Communication Skill
 12.30 – 13.30 Lunch
Plenary
 13.30 – 14.30 Process Waste
 14.30 – 15.30 Process and Product Performance Review and Continuous Improvement
 15.30 – 16.00 Break
 16.00 – 17.00 Management Review
 17.00  Closing

 


» Read Announcement ISPE Annual Conference 2015 ( Pdf File)


 

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