Auditing API Facilities: A MUST to properly prepare for an FDA Regulatory API GMP Inspection 2019

  • 15 May 2019
  • Webinar

Description

Topics
  • What is the most critical understanding needed for success
  • Discusses what will be covered during this program
  • What and where to look
  • Suggested process to follow including: what to review before and during the audit
  • No Data Integrity Issues Observed
  • No smoking guns observed
  • How the Audit should Start and End
  • Review all appropriate areas including Critical Operations/Systems/Records
  • Opening/Ending/ and Follow-up Actions to the Audit
  • Where are the key areas and systems
Who should Attend
  • Manufacturing
  • Quality
  • Distribution
  • Engineering
  • Key personnel
  • Regulatory management

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Important

Please, check "Auditing API Facilities: A MUST to properly prepare for an FDA Regulatory API GMP Inspection" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Management, Quality assurance

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