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Compliant GCP (Good Clinical Practice) Studies – Working with a CRO
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- Steps to meet the sponsors requirements.
- How to know - are GCPs being followed and is it documented.
- Know the “relationships” - QA, Clinical and the CRO.
- The Audit (aspects and specifics).
- How to do an audit follow-up.
- Post CRO Assessment - How
Objectionable Microorganisms: Considering the Risk
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- What is an Objectionable Microbe?
- Pathogens vs. Objectionables.
- Just how objectionable is it?
- Consider the risk.
- Performing a risk assessment.
Advanced Topics in Good Documentation for GXPs
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- The documentation practices that enhance study integrity, repeatability.
- How to prevent 483 items related to data documentation.
- The main documentation errors seen and cited by the FDA.
- Why GLP serves as a good foundation for clinical studies, GMP, and even research.
- Tips for documentation in lab notebooks.
- Undertanding Japanese culture in context of JPAL.
- Risk adversity in the MHLW, PMDA and filtering down to the MAH.
- Language: Translations, interpretations and resulting gaps.
- Technical differences - How to respond and persevere.
- Culture differences - Sometimes we just have to go along.
- Submission data - Best practices for common understanding.
Basics of testing associated with sterilization validation and routine processing
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- What are the appropriate types of tests during sterilization validation.
- What standards should be used for the testing.
- What type of samples and sample sizes should be used.
- What testing needs to be performed routinely.
- What frequency of testing is recommended.
- What methods can be used to reduce testing.
Source: ComplianceOnline
