Friday May 18, 2012 Friday May 18, 2012
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| Date:Tuesday, February 7, 2012 | |
| Registration Single Attendee: CAD $195.00 Group rates are available. (see below) All rates are subject to the Canadian 13% Harmonized Sales Tax (HST) |
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Time: 1:00 PM ET | 10:00 AM PT | Duration: 1.5 hours (15mins Q&A) |
This webinar will detail the recent issues in Dissolution Testing that are getting attention, including recent initiatives at USP. The activities of the new expert committee that takes the place of the previous Biopharmaceutics committee, called Pharmaceutical Dosage Forms will be discussed. First, there are many unresolved issues with the Two Tier testing allowed in <711> where enzyme is added to media when dissolution failures are observed with capsules shell/gelatin products. The new USP General Chapter <1094> Liquid Filled Capsules will be presented. Dietary Supplements have challenging aspects when dissolution testing is applied and what is the role of the rupture test? The talk will also explain the new Performance Verification Testing (PVT) criteria used for Apparatus 1 and 2. New general chapters about performance tests for topicals, transdermals, and chewing gums will be presented as well as proposed revisions to other chapters such as USP General Chapter <1092> Dissolution Procedure: Method Development and Validation and USP General Chapter <711> Dissolution.
Attendees would include Dissolution Analysts and Managers that are involved in all aspects of dissolution testing that are concerned with USP General Chapters on Dissolution topics. Companies that test Capsule products will find the information very useful, including the lab analyst, R and D management, manufacturing, and formulators. Those interested in the performance verification of the dissolution apparatus will benefit from the discussion of the new PVT acceptance criteria. Those involved in Topical and Transdermal products will find the webinar informative.
Vivian Gray has spent the last 35 years involved in all aspects of dissolution testing and evaluating new dissolution technology. In the 23 years she was at USP she was progressively a bench chemist, supervisor of method development, and then the liaison to the USP Biopharmaceutics Expert Committee. In 1997, Vivian joined the DuPont –Merck Pharmaceuticals Company as the Head of the Analytical R & D Dissolution Group. She now serves on the USP Pharmaceutical Dosage Form Expert Committees and is chair of the USP Expert Panel on Gelatin Capsule issues. She has lectured frequently, especially in the areas of calibration, dissolution equipment, method development and validation, setting specifications, GMP, and regulatory/filing issues.
In 2002, she began a consulting business in dissolution testing and related areas. The company name is V. A. Gray Consulting, Inc., www.vagrayconsulting.net. Vivian is also Managing Director of the publication of Dissolution Technologies, www.dissolutiontech.com, a quarterly, international peer-reviewed niche journal on dissolution and related topics. She recently co-authored a book titled “Handbook of Dissolution Testing”, Third Edition.
Single Attendee: CAD $195.00
Group of 5 or less per location: CAD $400.00
Group of 6 to 10 attendees per location: CAD $750.00
Group of 11 to 20 attendees per location: CAD $1250.00
Single attendee refers to single participant at a single computer/login.
Group rates only apply to candidates who wish to have more than one attendee, but will be attending the webinar from a single computer/login. If multiple candidates wish to login at different locations, it will be considered as a separate additional registration and will require more than one webinar login information. Also note that one login information will only be valid on one computer.
Please contact us at webinar@ipacanada.com for multiple-location group rates or any other enquiries.