Validation and Regulatory Affairs Graduate Certificate


Program Director
Richard Berkof

Many individuals work or aspire to work in the validation part of the industry, to test and confirm that equipment  and processes meet all specifications.  For those individuals, this graduate certificate provides more detailed studies of the general concepts, specific applications to computerized systems, compliance issues, and quality aspects of manufacturing.



Course #Course NameInstructor (s)Semester
MGT684 or PME542Regulation and Compliance in the Pharmaceutical IndustryElaine Lehecka-PrattFall-2009, Spring I-2010
PME/ME/CHE540Validation and Regulatory Affairs in Pharmaceutical ManufacturingAndrew Walsh, Louis Angelucci, Daniel WasserFall-2009, Spring I-2010
PME/ME/CHE541Validation of Computerized SystemsAndrew Walsh, Rodrigo Fernández, Anthony Arturi, Daniel WasserFall-2009
PME/ME/CHE560Quality in Pharmaceutical ManufacturingSandra Khalil, Elaine Lehecka-PrattFall-2009, Spring I-2010
PME640Contemporary Concepts in Pharmaceutical ValidationAndrew WalshFall-2009


General Information
Credits 3 Credits Per Course/12 Credits Per Certificate
Tuition per credit $1100 per credit
Current Schedule Click here
Semester information Long Range WebCampus Academic Calendar
Application Apply
Phone 201-216-5092
Toll Free 1-800-496-4935
FAX 201-216-5011
Email webcampus@stevens.edu
Mail WebCampus.Stevens
The Graduate School
Stevens Institute of Technology
Castle Point on the Hudson
Hoboken, NJ 07030
United States of America

A graduate certificate program from Stevens' Charles V. Schaefer School of Engineering available online. Co-sponsored by AACEI, ACM, AIChE, ASCE, IEEE, NECA, NSPE, and SNAME.

If you're a professional with a bachelor's degree, you can earn a graduate certificate in an outstanding online Validation and Regulatory Affairs program delivered by the same superior faculty who teach in conventional settings. You receive the finest professional education using rich Internet features -- threaded discussions, chat, bulletin boards, e-mail, file sharing, whiteboards, and workgroups for in-depth participation. You also have online library privileges, with instant search and retrieval of important databases.

The course discussion questions encouraged everyone to talk. I am surprised at the amount of similarities between everyone’s respective fields."
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