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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

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