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Compliant GCP (Good Clinical Practice) Studies – Working with a CRO

Learn here

• 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

Learn here

• 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

Learn here

• 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.

Japanese PAL – JPAL Technical, cultural and language challenges when dealing with MAH, PMDA, Distributors and Customers

Learn here

• 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

Learn here

• 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