Pauline has over twenty years experience in analytical chemistry. Eighteen years in the pharmaceutical industry has given her the opportunity to work for Companies such as Syntex, Pfizer and Novocol . She also has experience working in Contract 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 at Napier University in Edinburgh where she also taught analytical techniques to undergraduate students.
On completing her Ph.D in 1995, she came to UWO in London, Ontario to complete her post doctoral studies. Her project involved the analysis of beer in collaboration with Labatt.
Since then she has worked as a validation specialist at Pfizer, a consultant to the pharmaceutical industry and taught analytical and organic chemistry courses.
Pauline spent three years at SGS Life Science Services as the Manager of Research, Development and Validation. She currently works as a Training Specialist with PMcG Consulting. Recent training courses have included a 5 day training session in China on Method qualification of company and compendial methods.
Presentation Materials, Luncheon, Refreshment and Free Parking
Note: Please indicate any special Dietary requirements when registering for the course
April 19, 2012
9:00 a.m. – 5:00 p.m.
CAD $885.00 + HST
AAPS Training Center
200 Consumers Road, Suite 200, Toronto, Ontario, M2J 4R4
Tel: 416-502-2277
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 and following up on corrective and preventative action plans.
This course is presented in a dynamic environment created by a power point presentation, interactive exercises, case studies and group discussion.
The workshop emphasizes practical issues such as:
The course provides ample opportunities for group discussions, case studies and exercises. It enables participants to gain the skills and knowledge necessary to meet the FDA, Health Canada’s and other regulatory agencies’ current expectations.
How actual OOS observations could have been prevented
Performing an OOS investigation
Creating an investigation check list
Individual and group case studies
Applying learned techniques to a specific task (note participants are asked to come with a specific topic in mind for this exercise)
This two-day course is valuable for Directors, Managers, Supervisors, Associates in the Pharmaceutical, Biopharmaceutical, Vitamins, Herbals, Medical Devices and allied industries with daily responsibilities in the following areas:
|
Join our social network.   
Academy of Applied Pharmaceutical Sciences (AAPS) Inc. |