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Overview:
Many organizations, such as FDA, ISO, OSHA, and EPA, can conduct audits or inspections in a biotech company. Most people view these events as scary, but there are ways to make them less difficult. The first method is compliance with the applicable rules. After that, preparation is the key. We will focus on these preparatory techniques, for example, using internal auditing as a tool, developing an inspection procedure, educating employees, and conducting mock inspections. Participants will roll-play being auditors and auditees.

By the end of the course, participants will have gained:

  • Understanding of the role of an auditor
  • Ways to prepare for an audit or inspection
  • Method for conducting a mock inspection
  • Tips on communicating with inspectors and auditors

Course Outline:

  • Introduction to FDA inspections
  • Introduction to ISO audits
  • Overview of other regulatory inspections
  • Compare and contrast
  • Preparation tools and techniques
  • Communicating with inspectors/auditors
  • Resources

Who Should Attend:
Anyone working in a medical device or drug company! Specifically, managers, supervisors, and personnel in customer service, purchasing, engineering, manufacturing, quality assurance, or related disciplines.

Prerequisites:
No prerequisites.

Cost: Half-day class

Location: Location and driving directions will be emailed separately upon registration.