Residual Solvents Testing:
Strategies to Meet the USP <467> Requirements
Industrial Short Course
November 3, 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 University of Wisconsin-Madison professional development course is designed to provide participants with an understanding of the global requirements for residual solvents testing and practical strategies to meet the requirements, using resource-sparing approaches when appropriate. It will include a review of the compendial analytical methods, and discussion on use of alternative methods. There will be ample opportunity to discuss questions and challenges from the participants. Upon completion of this course the learner should be able to:
- discuss the requirements for residual solvents in the US, EU and Japan;
- implement a testing program to assure compliance with the requirements, using compendial or alternative methods and
- apply strategies to minimize the testing and resources required to meet the requirements
Short Course Program General Information
Who should attend
Chemists (Research, Quality Control, CRO) involved with residual solvents testing and their managers, and regulatory affairs/CMC personnel responsible for documenting compliance with residual solvents requirements.
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) Regulatory Landscape
a. ICH, USP, EP and JP
b. Recent guidance from FDA
2) Practical implementation of the requirements
a. Classification of Solvents: Class 1, 2 and 3
b. Options for Compliance
c. Decision Tree
3) Analytical Methods
a. Compendial procedures
b. Alternative methods
4) Risk based strategies to minimize testing and resources
5) Common issues and practical solutions
a. Managing suppliers and CROs
6) Review of Course Contents
7) Interactive Session
a. Questions and Answers
b. Situations encountered by the audience
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.