Preparing for Regulatory Inspections

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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.

No prerequisites.

Cost: Half-day class

Location: Oregon Bio Virtual Classroom


July 11
8:00 am - 12:00 pm
$200.00 – $250.00
Event Categories:
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Portland State Business Accelerator – Mt. Hood Room
2828 S. Corbett Ave.
Portland, OR 97201 United States
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Prep for Inspections - Member
Employees of Oregon Bioscience Association member companies receive discounts on BioPro classes. Visit the Membership Directory for a list of current member companies.
$ 200.00
Prep for Inspections - Non Member
$ 250.00