Developing and Troubleshooting Dissolution Methods
Industrial Short Course
November 2, 2009
Doubletree Somerset Hotel & Executive Meeting Center
200 Atrium Drive
Somerset, NJ
Short Courses for the Pharmaceutical Industry
Registration
Your registration options are as follows:
The registration is $950.00 and Early bird discounts ($750) are offered to individuals registering prior to October 18, 2009.
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Register Online. Login in using your user account. If you don't have a user account creating one is free & easy. |
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Download the registration form, complete & mail to: Pharmacy Short Courses |
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By phone at 608.262.3130 or toll-free at 877-947-4255 using a credit card for payment. |
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Download the registration form, complete & fax to 608.262.2431 using a credit card for payment. |
Goals & Objectives
Goals and Objectives
This interactive professional development course presented by the University of Wisconsin-Madison is designed to provide practical tools for those developing dissolution methods at various stages (including biorelevant methods), and to provide an understanding of the development process for managers, formulators and regulatory affairs/CMC personnel Building on the history of dissolution, learner is presented with a systematic approach to develop dissolution methods. The course emphasizes troubleshooting methods when changes in dissolution profiles are observed, and understanding the causes for those changes, including opportunities to discuss real or hypothetical situations. The topics of biorelevant dissolution, setting specifications and integration of Quality by Design principles are introduced in a manner than facilitates practical implementation. Finally, several key regulatory and compendial documents are discussed to assist the learners in connecting regulatory expectations with their methods. Upon completion of this course the learner should be able to:
- develop a dissolution method for a pharmaceutical dosage form, using the target product profile and drug substance solubility data;
- evaluate changes in dissolution profiles and determine probable root causes and potential solutions;
- describe the principles and application of biorelevant dissolution, setting specifications and Quality by Design principles to dissolution methodology; and list the appropriate regulatory or compendial documents which may be pertinent to the situation under evaluation.
Short Course Program General Information
Who should attend
Chemists (Research, Quality Control, CRO) involved with dissolution method development or testing and their managers, formulators who rely on dissolution data and regulatory affairs/CMC personnel responsible for filings involving dissolution.
Location
Doubletree Somerset Hotel & Executive Meeting Center
200 Atrium Drive
Somerset, NJ 08873
(732) 469-2600
The day begins (8:00am) with a continental breakfast and includes lunch and break service throughout the day. All classes will begin at 8:30am and end at approximately 5:00pm.
Accommodations
Blocks of hotel rooms have been reserved at the DoubleTree Hotel at the rate of $99.00 per night. Reservations should be made directly with the hotel at (800) 222-TREE and request University of Wisconsin Short Courses block. To guarantee this special room rate, reservations must be made by October 16.
Enrollment & Fees
One-day Short Course (any of the six other programs) $ 950
Payment received prior to October 18, 2009: $ 750
Contents
1) History of Dissolution and the Compendial Apparatus
2) A Practical Approach to Method Development
3) Validation of Dissolution Methods
4) Method Troubleshooting
a. Method Robustness
b. Differences Among Potencies
c. Impact of Stability
d. Lot-to-Lot Variability
5) Biorelevant Dissolution
6) Setting Specifications
7) Dissolution and Quality by Design
8) Regulatory Reference Documents
9) Compendial Chapters
Instructor
Gregory P. Martin, M.S.
President
Complectors Consulting LLC, Pottstown, PA
Mr. Martin has over 29 years experience in the Pharmaceutical industry. He is President of Complectors Consulting, which specializes in Pharmaceutical Analytical Chemistry, including dissolution, impurities and residual solvents, HPLC method development and validation and cGMP/USP/ICH topics. He is currently Vice Chair of the USP General Chapters Expert Committee and was previously Director of Pharmaceutical Analytical Chemistry at Merck Research Laboratories.
For More Information
James E. De Muth, Ph.D., Conference Director
Extension Services in Pharmacy
777 Highland Avenue
Madison, WI 53705
(608) 262-3130
FAX (608) 262-2431
Send Email
Special Offer for Academic Institutions
Extension Services in Pharmacy at the University of Wisconsin School of Pharmacy has instituted a new policy for industrial professional development programs to encourage greater participation by faculty, graduate students and post doctoral students at academic institutions. Programs will be offered at a significantly reduced price, based on space availability. For information about any specific course please contact Dr. James E. De Muth by email.
