2019: The ISPE Indonesia Annual Conference

Rabu, 26 Juni 2019
Dibaca : 556 Kali

The ISPE Indonesia Annual Conference is a prestigious event for pharmaceutical industri and their stakeholders, the theme for 2019 event is Sustainable Compliance Driving Business Growth, which include a plenary session and 6 breakout track.

PROGRAM. PLENARY: Keynote Speeches and Panel discussions

Track 1: Leadership and Quality Culture
Track 2: Driving from Conventional to New Technology
Track 3: Quality Data Integrity
Track 4: Control Strategy
Track 5: New Manufacturing Trends
Track 6: Sustainable Compliance

Agenda. Day 1 - Monday, 24 June 2019

08.00 - 08.45: Registration. Plenary (Angsana 1)
08.45 - 09.00: Opening (ISPE Indonesia)
09.00 - 09.30: Keynote Speech - Dirjen Kimia, Farmasi dan Tekstil Kementerian Perindustrian Republik Indonesia (Ir. Achmad Sigit Dwiwahjono, M.PP)
09.30 - 10.15: Expo Opening, Break
10.15 - 11.00: Indonesia 4.0 - Direktur Industri Kimia Hilir dan Farmasi Kementerian Perindustrian Republik Indonesia (Dr. Ir. Taufiek Bawazier, M.Si)
11.00 - 12.00: Industry Leaders Readiness for the Coming Industry 4.0 (Rhenald A. Khasali)
12.00 - 13.00: Lunch
13.00 - 13.45: Driving Quality Culture through Leadership (Raman Roestan, Direktur Utama PT. Bio Farma Persero)
13.45 - 14.45: Quality is Free (Frans Mardi Hartanto)
14.45 - 15.15: Break
15.15 - 15.45: Rusian Regulator (Vladimir Orlov)
15.45 - 16.15: Current Regulation and Requirement to Export Product to Australia (Dr. Stephen Firmer, Asia Pasific Consultants)
16.15- 16.45: Malaysian Regulator (Mohammad Lukmani)
16.45 -17.00: Panel Discussion (Retno Tyas Utami)
17. 00: Closing

Agenda. Day 2- Tuesday, 25 June 2019

Track 1 :Leadership and Quality Culture

08.30 - 09.15: Journey to Sustainable Compliance (Rendy Nasution, PT Bayer Indonesia)
09.15 - 10.00: Executives Roles on shaping Quality Culture (Benni Sutisna -Dexa Group)
10. 00 - 10.45: Become Visionary Leader (Frans Mardi Hartanto)
10.45 - 11 30: Break

Track 3 : Quality Data Integrity

11.30 - 12.15: E-QMS / PQS : Data Integrity by Design in Paper and Hybrid (Pipiet Manuhpitasari, Factory Talk)
12.15 - 13.00: Chromatographic Software Capabilities to Help meet your Data Integrity Requirement (Bernard YS Tan - Lab Informatics Agilent Technologies)
13.00 - 14.00: Lunch

Track 5 : New Manufacturing Trends

14.00 - 14.45: Increased Plant Productivity and Safety by Process Linking (Frederic Dietrich- Dietric Engineering Consultants s.a.)
14.45 - 15.30: Approach of Data Integrity Implementation in Manufacturing (Indra Gunawan PT Bayer Indonesia)
15.30 - 16.00: Break
16.00 - 16.45: Continuous Bioprocessing for mAbs and Proteins : Upstream to Downstream, Formulation & Filling (Xiang Liang Lin -Esco)
16.45 - 17.30: Biosimilar Regulation in Indonesia (Juliati , S.Si ,M.Biomed. BPOM)
17.30: Closing

Agenda. Day 2- Tuesday, 25 June 2019

Track 2 : Driving From Conventional to New Technology

08.30 - 09.30: Risk Management in Storage Stability Testing, a Risk and Science Based Approach (Roland Kerbs - Nagano)
09.30 - 10. 15: From Industry 4.0 to Pharma 4.0 : The Holistic Control Strategy (Orchun Thakral -Werrum)
10. 15 - 11.00: Risk Based Commisioning and Qualification (Joonleong Ng -No Deviation)
11.00 - 11.30: Break

Track 4 : Control Strategy

11.30 - 12.15: A New Concept for Safer Medicines : Serialization and Aggregation (Bart Vansteenkiste- Domino)
12.15 - 13.00: oRABS vs Isolation Techmology and Design Implementation of CIP/SIP Systems Applied to Isolated Filling Lines (Andrea ZANOTTO - IMA Life Division)
13.00 - 14.00: Lunch

Track 6 : Sustainable Compliance

14.00 - 14.45: A Practical Approach to Cleaning Validation- Guidelines ,Toxicological Limits, Sampling (Richard Chai - Steris)
14.45 - 15.30: Practical Implementation of The Lifecycle Approach to Process Validation (Maurice Parlane)
15.30 - 16.00: Break
16.00 - 16.45: Applying Continuous and Ongoing Process Verification during Lifecycle: from Control Strategy to Product Quality Review (Maurice Parlane)
16.45 - 17.30: Business perspectives -How Quality drive the Business (Krestijanto Pandji)
17.30: Closing.

Related Link
Contact Us

ISPE Indonesia Affiliate Secretariat

Website : www.ispeindonesia.org

alamat Titan Centre
Jln. Boulevard Bintaro, Block B7/B1 No.5 Bintaro Jaya, Sektor 7
Tangerang 15244, Indonesia
telp +62 21 745 2673
fax +62 21 745 2614
email info@ispeindonesia.org

ISPE Headquarters

Website : www.ispe.org

alamat 600 N. Westshore Blvd., Suite 900
Tampa, Florida 33609 USA
telp +1-813-960-2105
fax +1-813-264-2816
email ask@ispe.org
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