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.
Date: Thursday August 23rd & Friday August 24th 2012, 8:00 AM to 4:00 PM PDT
Venue: Sheraton San Diego Hotel and Marina, CA
Registration Cost: $1049 per registration
Early bird discounts: For discounts on early registrations, please click here.
Register by phone: Please call our customer service specialists at +1-650-620-3937 or email to customercare@
For more information on ComplianceOnline or to browse through our trainings, please visit our website.
ComplianceOnline is a leading provider of regulatory/compliance trainings for companies and professionals in regulated industries. ComplianceOnline has successfully trained over 20,000 professionals from 3,000 companies to comply with the requirements of regulatory agencies. ComplianceOnline is headquartered in Palo Alto, California and can be reached at http://www.complianceonline.com.
For more information please contact:
A Reuben Bernard
Manager of Program Marketing
2600 E Bayshore Rd
Palo Alto CA USA 94303