Sunday January 29, 2012
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International Pharmaceutical Academy (IPA) is a progressive Canadian organization dedicated to be the primary provider of Quality Education and Training for the Pharmaceutical, Medical Devices, Biologics, Cosmetics, and Allied Industries.
We present experts from industry, academia and government agencies. Providing the best in educational instruction in short course formats together with carefully orchestrated workshops.
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February 27-29, 2012 - Washington, DC
March 7-8, 2012, March 27-29, 2012 - Toronto, Canada
Day 1 - Wednesday March 7, 2012
Finance for the Non-Financial Executive
Day 2 - Thursday March 8, 2012
Foundations of Project Management
Day 3 - Tuesday March 27, 2012
Strategic Planning
Day 4 - Wednesday March 28, 2012
Balanced Scorecard and Presentation Skills for Leaders
Day 5 - Thursday March 29, 2012
Marketing Management for Leaders
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February 15, 2012 - Ottawa, Canada
The new FDA Guidance defines process validation as the “collection and evaluation of data, from the process design stage through commercial production”. The Guidance has raised expectations for both planning and scientific study. As the FDA now states that process validation “involves a series of activities taking place over the lifecycle of the product”, we will determine which activities must necessarily occur during Phase 1, 2 and 3 clinical trials. Elements of the revamped 3-stage lifecycle approach include process design studies, proof of principle manufacturing and ongoing statistical analysis. This workshop will review the guidance and identify activities during clinical trials which are necessary to build the process validation package. We will address concepts such as:
The workshop will review how to employ tools such as PDA Technical Report 42, ICH Q8/Q9 QbD, Risk Management, Quality by Design, Process Analytical Technologies and Statistical Process Control for all 3 stages of process validation. Firms invest deeply in process validation, we will review how to stage activities in order to realize the cost benefits and value from process validation activities. Implementing stage-appropriate best practices, will result in an optimized and fine tuned manufacturing process with data and results that speed the path to product licensure.
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February 16, 2012 - Montréal, Canada
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April 24-26, 2012 - Orlando, Florida
WORKSHOPS:
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We would like to thank all who has participated in our
IPA Holiday 2011 Webinar Draw.
The following five winners will be receiving a free admission to any IPA Webinar in 2012.
Congratulations to all our winners. You will be contacted by an IPA staff.
Stefan Wietek
Karine Cinq-Mars
Roger Diamond
Dawn Jennemann
Catherine Mazzrillo
Happy New Year!