ComplianceOnline Announces Seminar on Preparing for Laboratory Inspections
Online, August 26, 2012 (Newswire.com) - ComplianceOnline, the leading governance, risk and compliance advisory network with over 500 experts in various regulatory subjects, today announced a seminar on Laboratory Inspections - Be Prepared, Be Validated and Avoid Observations. The two day long, in-person seminar, led by quality systems expert Dr. Richard Poser, will be held on August 23 and 24, 2012 in San Diego, CA.
The seminar will look at the laboratory inspection process (covering audits such as GLP, cGMP, GCP and EPA) from the perspective of the auditor and the auditee. The course has been pre-approved by RAPS and participants will be eligible to receive up to 12 RAC credits toward their certification on completion.
For more information or to register for the seminar, please click here.
Seminar instructor Dr. Richard Poser has been both receiving and conducting audits in drug, laboratory, device, software and manufacturing environments for over 25 years and teaches from personal experience. He has been Director of Laboratories in R&D, clinical phase and commercial operations in drugs and medical devices. Dr. Poser has been a consulting quality systems advisor or auditor to dozens of diagnostic, biologics, pharmaceutical and medical device manufacturers including many of the Fortune 500.
During this interactive seminar, Dr. Poser will explain what auditors look for, best practices and real life examples of how audits can go wrong. The two day session will include presentations, discussions, exercises, role playing and workshops so that attendees can experience what it is like to be an auditor and how to receive an audit.
This course will include overviews of the various regulations that affect laboratories and provide understanding on how they drive the audit, including 21CFR Part 11. Forms and templates used in conducting audits will be handed out and training given on when and how to utilize these tools. All aspects of laboratory operations will be explored, including test methods validation, notebooks, instrument and equipment qualification, training records and data systems that are subject to audit.
This course will benefit laboratory managers, quality assurance, quality control, laboratory analysts/chemists and auditors. Those working in analytical development, regulatory compliance, contract laboratories, contract research organizations and contract manufacturing organizations will also benefit from attending this seminar.