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Parenteral Drug Association Connecting People, Science and Regulation ®

PDA Brazil Chapter Aseptic Processing Techniques Workshop

Nov 12 - Nov 16, 2018 |
Nov 16, 2018 |
Hotel Tribeca Buenos Aires Apart | Buenos Aires , Argentina
  • Chapter
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Objectives

  • Evaluate current aseptic processing procedures.
  • Assess potential risks of product contamination using airflow visualization techniques.
  • Determine the necessary components of an effective environmental monitoring program.
  • Describe the importance of filter integrity testing.
  • Examine the media fill operation to ensure appropriate interventions and observations occur.
  • Discuss finished product testing requirements.
  • Correlate basic microbiology concepts and techniques to multiple aspects of aseptic processing.
  • Demonstrate an understanding of sanitization techniques and disinfectant evaluation by properly operating different cleaning systems.
  • Interpret regulatory requirements for manufacturing sterile products produced by aseptic processing.

Speakers

David Masahiro - Keynote Speaker, study Microbiology and Chemical Engineering in San Jose State College. He worked as a consultant of aseptic solutions for KMI and Genentech In a variety of positions for environmental control. He specializes in water systems, environmental, and aseptic processing. Matsuhiro He is a member and speaker of the PDA and other professional associations

Fenando Marcellan - Pall
Jim Polarine - Steris
Frank Haerterich - Bausch-Stroebel
Roberto Uchimure - Merck Group

Program Planning Committee

Rose Nascimento, Libbs
Deolinda Martins, West
Alexandre Terada, Allergan
Luís Wenzel, Allergan
Tathiane Castro, Amgen
Jorge Anselmo, MSD
Tereza Amaral, PDA Brazil
Wolfgang Löscher Filho, Libbs
Leonidas Orjuela, AudisisVale
Daniela Sanchez, Das Labor

Monday, November 12th

  • Introduction - PDA Brazil Board
  • Types of Aseptic Processing
  • Smoke Study Lecture
  • Computational Fluid Dynamics Studies
  • Environmental Monitoring
Tuesday, November 13th
  • International Speakers Sponsors lectures
  • Clean Room hands on training
Wednesday, November 14th
  • International Speakers Sponsors lectures
  • Clean Room hands on training
Thursday, November 15th
  • Gowning and Personnel Monitoring
  • Contamination Control and Aseptic Techniques
  • Risk Assessment
Friday, November 16th
  • Media Fill / Media Hold
  • Media Fill failure investigation
  • Reading Plates
  • Regulatory Perspective
  • Questions and Answers

Event price US $ 1.000,00

Pay by Credit Card using the "Register now Button"

Hotel Tribeca Buenos Aires Apart
Bartolomé Mitre 1265,
C1036AAW CABA,
Argentina

Event Sponsorship price: US $3,000.00

Follow this link to process sponsorship payment online.

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4583

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