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  Events - October 2012

00S Investigations in a GMP environment

23 Oct 2012 - 24 Oct 2012 - London, UK

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This course is designed to provide essential training for conducting Out of Specification (OOS) investigations in a GMP environment. A background discussion of the associated GMP documentation required to support the OOS investigation is included but the majority of time is spent detailing the who, what, when, how and why of the investigation, determining the extent of the investigation during Phase I and Phase II, documenting findings determining root causes and assigning corrective and preventative actions. An introduction to OOT (Out of Trend) results and an overview of the different types and how they are typically handled is also discussed using industry examples in the first session of this course. This course is presented in a dynamic environment created by a power point presentation, interactive exercises, case studies and group discussion. Participants are welcome to bring their own examples for group discussion sessions.

The workshop emphasizes practical issues such as:

• What is an OOT?
• The importance of good quality support systems
• FDA audit observations and how they could have been avoided
• Case studies for OOS results
• A detailed guide to conducting Phase 1 and Phase II of the OOS investigation
• Reporting and evaluating passing and failing results
The course provides ample opportunities for group discussions, case studies and
exercises. It enables participants to gain the skills and knowledge necessary to
meet current regulatory expectations. The course material is based on the
FDA guideline “Investigating Out-of-Specification (OOS) Test Results for
Pharmaceutical Production”, October 2006
Who should attend
This Two-day course is valuable for Directors, Managers, Supervisors, Laboratory
Analysts and Associates working in a GMP environment in the Pharmaceutical and
related industries with daily responsibilities in the following areas:
• Quality Assurance
• Documentation and Technical Writing
• Quality Control Laboratory
• Regulatory Affairs
• Contract Laboratory
• Analytical Laboratory
• Project Management
• Training
Course Speaker

Dr Pauline McGregor
Twenty years in the pharmaceutical industry has included working for pharmaceutical companies and Contract Testing Laboratories in Canada and the UK

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