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DTSTART;TZID=America/Los_Angeles:20200723T130000
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DTSTAMP:20200716T160844Z
CREATED:20200706T180657Z
LAST-MODIFIED:20200716T160844Z
UID:10000207-1595509200-1595523600@www.otradi.org
SUMMARY:BioPro: Preparing for Regulatory Inspections
DESCRIPTION:Overview:\nMany 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. \nBy the end of the course\, participants will have gained: \nUnderstanding of the role of an auditor\nWays to prepare for an audit or inspection\nMethod for conducting a mock inspection\nTips on communicating with inspectors and auditors\nCourse Outline: \nIntroduction to FDA inspections\nIntroduction to ISO audits\nOverview of other regulatory inspections\nCompare and contrast\nPreparation tools and techniques\nCommunicating with inspectors/auditors\nResources \nWho Should Attend:\nAnyone working in a medical device or drug company! Specifically\, managers\, supervisors\, and personnel in customer service\, purchasing\, engineering\, manufacturing\, quality assurance\, or related disciplines. \nPrerequisites:\nNo prerequisites.
URL:https://www.otradi.org/event/preparing-for-regulatory-inspections/
LOCATION:OR\, United States
CATEGORIES:Partner Programs/Events
GEO:43.8041334;-120.5542012
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