PDA Brazil Chapter Webinar: Annex1 Manufacture of Sterile Products
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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
More information coming soon.
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