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| Email |
rebecca@ipacanada.com
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| Category |
Health: Medicine
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| Category 2 |
Health: Professions
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| Category 3 |
Science: Biotechnology
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| Description |
A Two Day COMPREHENSIVE & INTERACTIVE COURSE with Workshops and Discussions On:
- GMP Guidelines and Expectations for Aseptic Processing
- FDA Aseptic Processing Guidance; EU Annex 1 Revisions
- Avoiding Common Problems in Sterile Filtration
- How to Establish a Sterility Sampling Program
- Setting Media Fill Requirements and Acceptance Criteria
- Conducting a Media Fill Failure Investigation
- Proper Incubation Methods and Issues
- Strategies for Investigating Sterility Failures
- Conducting Laboratory and Manufacturing OOS Investigations
- Using Corrective and Preventative Action Plan (CAPA)
- Cleanroom Design Criteria and Maintenance Programs
- Personnel Training and Operator Qualification
- Equipment and Process Qualification Requirements
- Designing the Cleaning Process in an Aseptic Environment
- Choosing Test Criteria for Markers supporting Cleaning Validation
- Document Control for the Cleaning Process
- Effectively Auditing Aseptic Processes and Facilities
- Vendor Selection and Documentation Requirements
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