Are you compliant with FDA requirements for cleaning validation? Today’s regulators are applying more fine-grained specifications and demanding more sophisticated procedures for planning, executing, and documenting your processes throughout a drug product’s lifecycle. This two-day intensive summit brings together industry leaders to help you exceed regulatory thresholds and avoid costly FDA inspection findings.
Featuring Representation From:
- Bristol-Myers Squibb
- ValSource
- Hospira
- Pharmatech Associates
- MedImmune
- Hyde Engineering
- Steris
- CPCI
- Astellas Pharma
Featuring Comprehensive Coverage On:
- Ensuring your Cleaning Program is FDA Audit Ready
- Cleaning Validation and Continued Process Verification
- Risk-Based Approaches to Cleaning Systems Design, Qualification and Ongoing Monitoring
- Cleaning Limits and Visual Inspection from the Analytical Perspectives
- Determine Cleanability and its Applications in Cleaning Validation
- Process Validation & Cleaning Strategies during Technology Transfer of Sterile Injectables
- EU GMP Changes and Its Impact on Cleaning Validation
- Quality by Design for Effective Cleaning Procedure
- Writing Cleaning Validation SOPs
- And Much More!
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