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Methods Development, Validation Procedures, and Conformity Assessment in the Analytical Laboratory

Type Course
Language English
Date April 5, 2008 to
April 6, 2008
Venue Doubletree New Orleans
300 Canal St
New Orleans, LA 70130
US
Chemistry Specialties
  • other
Chemistry Techniques
  • statistical analysis
  • other
Contact
ACS
1155 Sixteenth Street, NW
Washington, DC, 20036
US
1-800-227-5558 ext. 4508
202-872-6336
service@acs.org
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by Lilach Zuriel last modified 02-13-08 09:32 AM

Learn the fundamentals of quality assurance, quality control, and analytical methods validation and how to improve your FDA, WHO and OECD regulatory compliance directives for analytical data submissions. Key topics covered include: conformity assessment; analytical method optimization during development; case studies in the improvement of validation characteristics; data integrity and statistical evaluation of analytical data; and more.

Key Topics * Highlights of the guidelines derived from international standards-ISO 9000 and ISO 17025, GLP, GMP, etc. * Conformity assessment–what it is, how it is applied. * Analytical method optimization during development. * Case studies in the improvement of validation characteristics. * Method development and optimization in HPLC and wet chemistry. * ICH, AOAC, and USP guidelines for methods validation and other standards. * Regulatory submission packages for IND, NDA, ANDA and other phases of development.

Speakers

Shib Mookherjea, a globally acclaimed speaker and consultant, has extensive experience in R&D, quality assurance, and quality management.

Cost

Category - ACS Spring National Meeting – New Orleans, LA Note - The course fee includes all course materials and a continental breakfast each day. Member - $1095 Academic Member - $547.50 Note: This discount is only available if you register by fax, mail or phone and mention this discount and may not be combined with any other offer. Nonmember - $1,245 Early Registration - Register before March 3, 2008 for the ACS Spring National Meeting Short Courses and receive $100 off the standard member/nonmember fees. Late Registration - Registrations after March 31, 2008 for the ACS Spring National Meeting Short Courses will be assessed a $100 administrative fee. Group Rate - Five for Four! Register five people for one course, one person for five courses, or any combination in between and your fifth registration is free. Note: This discount is only available if you register by fax, mail or phone and mention this discount and may not be combined with any other offer.

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