Training On Selecting the Right Contract Lab using Risk Based Approach

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Category Pharma

Deadline: February 26, 2013 | Date: February 27, 2013

Venue/Country: Houstan, U.S.A

Updated: 2013-02-08 20:00:42 (GMT+9)

Call For Papers - CFP

Due to the economy, many large pharma companies are right-sizing and creating opportunities for smaller pharmaceutical companies. However, most of the small companies typically do not have resources and technical expertise to fully support projects when needed. Therefore, they usually turn to outsourcing to fill the gaps. Selecting a contract lab is critical as they will be an extension of your lab and could help or jeopardize your project. This session will bring up different quality systems to look for in a contract lab.

Description of the Webinar :

Outsourcing becomes crucial to pharmaceutical industry. With the volatility of the economy coupling with the stream of corporate mergers, companies are pressured to turn to outsourcing as an extension of their laboratory. Project management, technical capabilities, data collaborations, quality assurance are areas that might be affected. This session will discuss key factors to consider when selecting a CRO for your analytical projects, and how critical activities should be monitor to ensure quality and safety of pharmaceutical products in global development.

Areas Covered in the Session:

System based inspections

Selecting a Contract Lab

Perform a technical evaluation

Audit CRO for analytical testing

Establish SOP for operations

How to communicate expectations

How to monitor processes

Who will benefit: (Titles)

Pharmaceutical development and manufacturing

Manufacturers of raw material and ingredients

Analysts and lab managers

QA managers and personnel

Regulatory affairs

QC personnel and managers

Webinar Includes

-Q/A Session with the Expert to ask your question

-PDF print only copy of PowerPoint slides

-60 Minutes Live Presentation

-Certificate of Attendance

About Speaker

Kim Huynh-Ba: As the founder and technical director of Pharmalytik, Kim Huynh-Ba's expertise focusses in Analytical Development, Method Development/Validation/Transfer, Stability and Outsourcing Project management. She has over 20 years of experiences in various areas of pharmaceutical development working with Wyeth, DuPont Pharmaceuticals, Bristol-Myers Squibb, ICI Americas (currently Astra Zeneca). In 2002, she has started her consulting and training organization. Her current clients include various sizes of pharmaceutical companies including those are under Consent Decree.

Kim Huynh-Ba is an active member of ACS, AAPS, PSDG, ASQ, POMA and serves in the Governing Board of Eastern Analytical Symposium (EAS). She is the founder and past-chair of the AAPS Stability Focus Group, and was on the Steering Committee of AAPS CMC Focus Group. She also is chairing EAS 2008 Short Course Program and AAPS APQ Distance Learning Office.

Kim Huynh-Ba received the 2008 Leadership Award from APQ and the 2008 Recognition Award from AAPS Regulatory Sciences.

Speaker : Kim Huynh-Ba

Product ID : F62184

Schedule Date :

Wednesday, February 27, 2013

duration : 01:00 to 02:00 PM EST

https://compliance2go.com/index.php?option=com_training&speakerkey=51&productKey=211