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USP Guidelines for Product Quality and Product Performance Tests

 
  July 21, 2009  
     
 
The Center for Professional Advancement, 90 Minute Accredited Online Training
September 24, 2009 at 11:00 a.m.–12:30 p.m. (EST)


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

 
 
Organized by: The Center for Professional Advancement
Invited Speakers: Dr. Nava Dayan, Skin Care Research Expert

Dr. Nava Dayan earned her Ph.D. in Pharmaceutics from the Hebrew University in Jerusalem specializing in skin delivery. She is an Associate Adjunct Professor in the Ernest Mario School of Pharmacy at Rutgers University. During her 20 years of experience she has specialized in a variety of areas related to skin treatment including:
  • The research and understanding of the interaction between topically applied compounds and the skin.
  • Findings in skin biochemistry and especially the upper layer of the skin- the stratum corneum
  • Delivery of active compounds into and through the skin and the development of delivery systems to facilitate transport, improve bio-availability and reduce toxicity
  • Design and development of topically applied formulations
  • Design of clinical studies to substantiate market claims and to assure safety
  • Academic teaching and lecturing
  • Industrial experience in both development of active compounds, delivery systems and finished formulations
  • Skin absorption studies in vivo and in vitro for safety/ efficacy assessment
  • In vitro methodologies for safety assessment of topically applied compounds
Dr. Dayan has received numerous awards of excellence for various papers she has authored. She is the author and coauthor of more then 80 publications. Dr. Dayan is a member of the Dermatopharmaceutics Focus Group, and the Abstract Review Committee for the American Association of Pharmaceutical Scientists (AAPS), and the Consumer Products Group of the International Controlled Release Society (CRS). She is also a member of the US Society of Cosmetic Chemists, and the chair of the Annual Cosmeceuticals Summit Symposium. Dr. Dayan teaches at Rutgers University and is the Director of several public and online courses at the Center for Professional Advancement.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: salbers@cfpa.com
 
   
 
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