Watch Laboratory Investigation Out-of-Specific-ation Results Event Streaming Online

In this 90-minute training on laboratory Out-of-specification (OOS) investigations, you will learn what constitutes an OOS observation, what is the OOS investigation process described in the OOS guidance and steps to be taken in the laboratory in the event of an OOS observation. Why Should You Attend: Inadequate procedures for laboratory Out-of-specification (OOS) investigations remain high on the list of FDA observations. The FDA has issued a guidance on the topic. OOS procedures and investigations are still a topic of FDA Investigator review and findings. Areas Covered in the Seminar: * Regulations and Guidances that will be covered (FDA, EU, Canada, WHO, ICH, other). * US. * 21CFR211.160 * FDA Guidance to the Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production * ICH. * Q7; 11.1 * Canada. * C.02.015 Who Will Benefit: The following individuals or disciplines will benefit from attending this Webinar: * Quality Control Managers * Quality Control Supervisors * Quality Control Analysts * Quality Control Record Reviewers * Quality Assurance Managers * Quality Assurance Supervisors * Quality Assurance Record Reviewers Instructor Profile: John G. (Jerry) Lanese, PH.D. CMC is the President of The Lanese Group, Inc, an independent consulting service provider that specializes in Quality Systems and Laboratory Controls. Jerry has taught at the college level and worked in various Quality Control and Quality Assurance roles in small and large pharmaceutical firms. more