This training program is designed for people tasked with performing external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have quality management system responsibilities for making general improvements in their organization’s performance specifically related to equipment, processes and documentation. The various regulatory agencies have expectations that suppliers and vendors will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implemented what they have stated in written procedures and whether their people are doing what the organizations procedures state they will do. Areas Covered in the Session : Understand what a supplier and vendor audit is Understand the background and basics of supplier and vendor auditing Understand proper auditor conduct Communication Dress Punctuality Difficult situations Learn the necessary skills for conducting audits Understand how to prepare and plan for a supplier and vendor audit Understand and know how to properly perform an audit Opening meeting Touring the facility Questions Observations Close out meeting Learn proper questioning techniques Understand proper audit observation classification Learn to write an audit report Understand conducting a follow up audit Learn how to become lead auditor certified ASQ Certification ISO Certification Who Should Attend: Senior Quality Managers Quality Professionals Regulatory Professionals Compliance Professionals Production Supervisors Validation Engineers Manufacturing Engineers Production Engineers Design Engineers Process Owners Quality Engineers Quality Auditors Document Control Specialists


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Areas Covered in the Session :

  • Review the current regulatory requirements and guidances (CFR, EU GMPs, ISO, etc.) for environmental monitoring.
  • Discuss issues of sampling methods, selection of sampling sites and the justifications for them.
  • Review the issue of contamination control as an important aspect of EM programs.
  • Discuss the issue of action and alert limits, trending of data and the handling of excursions.
  • What are the most common deficiencies cited by regulatory auditors when auditing environmental monitoring programs?
  • Attendee question and answer period.

Who Should Attend:

  • QA/QC Teams
  • Manufacturing Teams
  • Engineering Teams
  • Validation Teams
  • Regulatory affairs Teams
  • Management Teams
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