2-day In-person Seminar: Laboratory Inspections – Be Prepared, Be Validated and Avoid Observations (Laboratory Complianc)

Venue: Sheraton San Diego Hotel and Marina

Location: San Diego, California, United States

Event Date/Time: Aug 23, 2012 End Date/Time: Aug 24, 2012
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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.

This seminar will include overviews of the various regulations that affect laboratories and understand how they drive the audit, including 21CFR Part 11 as so many modern laboratories rely on computer-based data acquisition and reporting. We will provide forms and templates used in conducting audits, and train on when and how to utilize these tools. Each participant will write an audit observation as an auditor, and separately respond as an auditee to an observation and design a corrective action plan. We will explore all the aspects of laboratory operations including test methods validation, notebooks, instrument and equipment qualification, training records and data systems that are subject to audit.

You will leave these two days of training ready to receive an inspection with confidence in your new skills. You will be better prepared than ever before to be part of a less stressful audit with fewer observations.

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.


1380 Harbor Island Drive
San Diego
United States