00S Investigations in a GMP environment (2 day)
Venue: Window Conference Venue
|Event Date/Time: Oct 23, 2012||End Date/Time: Sep 24, 2012|
|Registration Date: Oct 23, 2012|
|Early Registration Date: Aug 17, 2012|
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:
â€¢ What is an OOS?
â€¢ The importance of good quality support systems
â€¢ FDA audit observations and how they could have been avoided
â€¢ Case studies for OOS results
â€¢ A detailed guide to conducting Phase 1 and Phase II of the OOS investigation
â€¢ 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 â€œInvestigating Out-of-Specification (OOS) Test Results for
Pharmaceutical Productionâ€, 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:
â€¢ Quality Assurance
â€¢ Documentation and Technical Writing
â€¢ Quality Control Laboratory
â€¢ Regulatory Affairs
â€¢ Contract Laboratory
â€¢ Analytical Laboratory
â€¢ Project Management
Dr Pauline McGregor
Twenty years in the pharmaceutical industry has included working for pharmaceutical companies and Contract Testing Laboratories in Canada and the UK.
Pauline completed her honours degree in Scotland on a part time basis while employed full time. She left the industry to pursue her PhD in photo organic chemistry where she also taught analytical techniques to undergraduate students.
On completing her PhD in 1995, she travelled to UWO in London, Ontario, Canada to complete her post doctoral studies. She is an experienced trainer and has been delivering analytical R& D, method validation, GMP and related Quality Systems courses across Canada, in the US, the UK and China . She is a very highly rated
Throughout her career, Pauline has identified a lack of shared knowledge between Manufacturing, Quality Control, R & D and Quality Assurance sectors in the Healthcare Industries. She believes there is a need for cross education and training to allow the different disciplines to communicate with each other so that realistic objectives can be met by all in a timely manner with a harmonised understanding.