Laboratory Inspections – Be Prepared, Be Validated and Avoid Observations - Seminar By ComplianceOnline

Course Description:

In every laboratory inspection there are always two teams – the auditors and the auditees. Whether you are performing the audit or receiving the audit, there are rules, techniques and tips that will make your job more effective and reduce audit observations. This interactive and exciting seminar will look at various laboratory audits (GLP, cGMP, GCP, EPA) from both perspectives. You learn what auditor s look for, see examples of best practices and also hear war stories of things gone wrong as you get to experience both sides of the process. We will use presentation, discussion, exercises, role playing and workshops so that you experience what it is like to be an auditor and how to receive an audit. 

Course Objectives:

• Be prepared to receive both internal and external audits.
• Reduce the anxiety, costs and observations of audits.
• Know what to say and show, and what Not to say and show.
• Understand how auditors think and what they are looking for.
• Write responses, audit observations, corrective actions and remediation plans.
• Learn the best practices for test method validation, instrument qualification and data system validation to avoid observations (“483s”).
• Know when to do what to meet audit requirements economically.
• Have the answers to the auditors' questions.