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PDA Brazil Chapter Webinar: Annex1 Manufacture of Sterile Products

Aug 03 - Aug 06, 2020
2:00 PM
-
5:00 PM
| E. South America Standard Time
Online
  • Chapter
  • Online

Overview

This month's webinar topics will focus discussions on:

  • Hot Topics from Annex 1
  • Comparison Annex 1- 2008/2017/2020
  • Evaluation of Annex 1 by PICs
  • IN35/2019 Implementation
  • Contamination Control Strategy
  • Viable and non-viable environmental and process monitoring
  • Quality Risk Management integrated into the product life cycle
  • Process Development and Validation
  • Installation and Equipment
  • Cleanroom and clean air equipment qualification
  • Utilities: Water Systems, vacuum, and gas
  • Personnel (skills, knowledge, and training) and Qualification of personnel
  • Rapid Methods
  • Isolators and RABS - Barrier Technologies
  • Summary of inspections for sterile products in Brazil

Event Panelists:

  • Andrea Geyer
  • Fritz Roeder
  • James Drinkwater
  • Jeanne Moldenhauer
  • Michael Miller
  • Walid El Azab

Download - Event Flyer

Registration Fees

Register Now
Registration Type Price (US Dollar)
PDA Member & Non-Member $300.00

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