Good Documentation and Record Keeping Best Practices (FDA & EMA)

Description

Good Documentation and Record Keeping Best Practices (FDA & EMA) is a webinar that covers topics such as: General Rules and Principles of GDP::

  • General Tips in GDP
  • Requirements of Records
  • Copying records
  • Signature / initial and the meaning
  • Recording the time and date
  • Document maintenance
  • Rounding rules
  • Correction of errors
  • Missing data
  • Back dating
  • Recreating / rewriting records
  • Voiding / cancelling records
  • Deviations

, Definition, Purpose, and Importance:: and Rules Governing Medicinal Products in the European Union (Vol. 4: Documentation)::

  • GDP Enforcement (examples from FDA warning letters)
  • What is new in the Latest Version?

Good Documentation and Record Keeping Best Practices (FDA & EMA) is intended for:

  • Research and Development Personnel (R&D) / Managers
  • Manufacturing & Production Personnel / Managers
  • Laboratory Personnel / Managers
  • Quality Assurance & Quality Control Personnel / Managers
  • Validation Specialists

Future Events

Good Documentation and Record Keeping Best Practices (FDA & EMA) 2020

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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