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: