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Course offering number:0910-705

Course ID:
2326
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USP Guidelines for Product Quality and Product Performance Tests
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT

Who Should Attend
Individuals in Pharmaceutical companies that are involved in product development of topical and transdermal delivery systems will find this course extremely beneficial. It will be especially valuable to personnel in the following areas:

  • Research
  • Analytics
  • Regulatory
  • Sales and marketing

Professionals in companies that produce skin care products will also benefit from this training.

Description
In its May- June 2009 Pharmacopeal Forum, the USP published a draft of general chapters 3 and 725 on topical and transdermal products. This chapter is key in understanding the progression of regulations in utilizing scientific methods and information for better product design. It is aimed to provide tools for the conductance of studies to assure quality and performance of these product categories.

This 90-minute accredited training course will discuss this initiative, its general concept and a few key details in study design.

Module 1:
  • The USP
  • USP-FDA
  • Topical and Transdermal product testing:
    – Product quality
    – Product Performance
  • Pharmacopeal forum May- June 2009
  • USP Workshop
  • What is between topical and transdermal

Module 2:
  • Topical Application–Implications on testing:
    Solution, Ointment, Collodion, Ophthalmic ointments,
    Creams, Pastes, Emulsion, Powders, Foams, Spray,
    Gels, Topical aerosols, Lotions, Topical suspension
  • Transdermal Delivery System

Module 3:
  • Product quality test
    –Topical
    –TDS
  • Product performance test
    –Topical
    –TDS

Summary and future direction
Question and Answer Session




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