2009 New Brunswick Course Series

Design of Experiments for Efficient and Practical Assay Development and Validation

Fri, 19 Dec 2008 18:42:42 GMT

October 19, 2009
This course covers design of experiments (DOE as used for development and validation of assays. The DOE topics covered will include factorial and fractional factorial designs, response surface designs, as well as nested and split-unit designs.

Assessing Packaging and Processing Extractables/Leachables

Fri, 19 Dec 2008 18:17:09 GMT

October 19-20, 2009
This lecture and discussion based course will review guidances and other regulations regarding the reporting, identification, measurement, and toxicological qualification of extractables/leachables from packaging materials into pharmaceutical products. A detailed discussion of the sources of extractables from packaging materials, such as plastic, glass and rubber, will be included. Extractables from both packaging and processing materials will be discussed. This course will provide the attendee with a synopsis of the current regulations and provide a means to deal with the issues in a responsible, scientific and cost-effective manner.

Fundamentals of Lyophilization

Fri, 19 Dec 2008 18:33:03 GMT

October 19-20, 2009
This course is designed for participants to develop an understanding of the basic principles and practical aspects of lyophilization technology.

Pharmaceutical Water Systems Design and Validation

Fri, 19 Dec 2008 16:09:40 GMT

October 19-21, 2009
This course is structured to address the design, operation, maintenance, microbiology and validation of pharmaceutical water systems.

Root Cause Investigation for CAPA

Fri, 19 Dec 2008 19:10:22 GMT

October 20-21
This course utilizes a template to guide the participants through the CAPA investigation and suggest appropriate tools.

Quality and Regulatory Requirements and Development Strategy for Pre-filled Syringes, Pre-filled Drug Delivery Devices and Other Drug-Device Combination Products

Fri, 19 Dec 2008 19:27:28 GMT

October 21, 2009
This course will provide a discussion, review and interpretation of relevant laws, regulations and guidance for best practices for the design, development, manufacture, testing registration and marketing of Combination Products in the US and Borderline Products in Europe. The program also focuses on solving practical quality, regulatory problems and development problems involving drug prefilled delivery devices.

Applied Quality Systems

Fri, 19 Dec 2008 19:21:07 GMT

October 21, 2009
New Brunswick, NJ, This course is designed to assist the participants in applying systems thinking to their quality program. Most compliance problems occur as a result of poor integration within and between processes.

Contact

Fri, 13 Mar 2009 08:51:57 GMT

Stephanie Ko
PDA Training and Research Institute
Manager, Lecture Education
Tel: +1 (301) 656-5900 ext. 151
Email: ko@pda.org

Location/Lodging Information

Fri, 13 Mar 2009 08:57:14 GMT

THE HELDRICH
10 Livingston Avenue
New Brunswick, NJ 08901
+1 (732) 729-4670

Rate
$175 Single/Double
Cut-Off Date: September 25, 2009

Registrationform-New-Brunswick-Course-Series

Mon, 06 Apr 2009 15:08:08 GMT

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