Managing Aseptic Processing Operations

Venue: Toronto

Location: Ontario, Canada

Event Date/Time: Aug 14, 2008 End Date/Time: Aug 15, 2008
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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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