Seminar, 28 February 2019. New Pharma Traceability Regulation: How to Achieve Compliance and Boost Production Efficiency

Tanggal Posting : Sabtu, 2 Februari 2019
Dibaca : 131 Kali

ISPE In Collaboration with ANTARESVISION. SEMINAR: NEW PHARMA TRACEABILITY REGULATION: HOW TO ACHIEVE COMPLIANCE AND BOOST PRODUCTION EFFICIENCY. February 28, 2019. Titan Center.

Serialization and Track & Trace for ethical pharma products, soon to be enacted in Indonesia, represent a huge challenge for the pharmaceutical industry. While contributing to the ultimate goal of patient safety, manufacturers and contract packagers have the demanding task of complying to regulations and, at the same time, keeping control on costs and minimizing validation efforts.

The aspect of product coding is just one of many that need to be considered into a bigger picture when implementing serialization and aggregation technology: several areas from plant engineering to IT systems, to operations, quality and training are going to be affected.

We will learn how the implementation of Track & Trace within production lines, distribution centers and IT infrastructure can generate a unique opportunity for boosting efficiency and adding value to supply chain management.

The purpose of this full-day seminar is to provide essential information on:

  • Requirements set out by the Indonesian NRA
  • Impact of serialization on production lines, warehouse, data management systems
  • Key steps to implement a serialization solution
  • Criteria for choosing the solution provider
  • Maximizing safety, performance and efficiency on packaging lines
  • Project planning and resources to deploy

Main topics to be covered in this seminar will be:

  • Regulatory compliance
  • Implementation roadmap: from project requirements to design, deployment and go-live
  • Standalone hardware solutions versus integration on packaging lines
  • Specific requirements for production lines and distribution centers
  • Specific options for companies with no e-management systems in place
  • Serialization data management and communication with authorities
  • Key factors for maintaining operational efficiency
  • Lessons learned from worldwide implementation experiences

Target audiences are Regulatory experts, Supply chain management, Plant engineering, IT systems engineers, Project management, Operations, Warehouse management, Quality & validation, Internal training, Packaging and artwork/marketing departments.

PEMBICARA: ISPE Indonesia bekerja sama dengan Antares Vision yang memiliki pengalaman sebagai implementor track and trace system.

REGISTRASI: ISPE Indonesia Affiliate Secretariat T: +62 21 7452673 F: +62 21 7452614 E: secretariat.ispeind@gmail.com

TEMPAT: TITAN Center, Jl. Boulevard Bintaro Blok B7/B1 No.5 Bintaro Jaya Sektor 7, Tangerang 15224

BIAYA SEMINAR: Anggota ISPE: Rp 600.000. Non Anggota: Rp 900.000.

Pembayaran dilakukan melalui transfer ke: Rekening ISPE Indonesia, BCA Cabang Sentra Menteng Bintaro No .6800-762888,  paling lambat 25 Februari 2019 dan tidak ada pembayaran di tempat.

Bukti transfer kepesertaan dikirimkan ke Sekretariat ISPE, melalui email: secretariat.ispeind@gmail.com

Catatan:

  • Pendaftaran paling lambat tanggal 25 Februari 2019 dengan mengirimkan formulir kepesertaan dan bukti transfer.
  • Kepesertaan anggota tidak dapat dialihkan kepada non anggota tanpa tambahan biaya.
  • Pembatalan paling lambat tanggal 25 Februari 2019 Pembatalan yang dilakukan setelah 25 Februari 2019 tidak ada pengembalian biaya pendaftaran.
  • Pengalihan kepesertaan paling lambat tanggal 25 Februari 2019 Peserta seminar akan memperoleh SKP dari IAI

Secretarial ISPE Indonesia Affiliate | Titan Center, Jl Boulevard Bintaro Blok B7/B1, Bintaro Jaya Sektor 7, Tangerang 15224. T: +62 21 7452673. F: +62 21 7452614. E: secretariat.ispeind@gmail.com

 

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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

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