KENX CONFERENCE COURSES OPEN TO STUDENTS (Remember, you can take these courses On-Demand, fitting them around your schedule….) 5000. KENX Conference Topics (1.5 credits each) (007) crn: 11575 Expectations of Online Students. Use the Registration Form for Online Courses for this course. Refer to the RAQA website for different conference topics and meeting dates, including Cleaning Validation, Environmental Monitoring, Disinfection OR Laboratory, Analytical and Stability Issues AND more! Conferences may be attended in person, or lectures may be watched on-Demand over a 6-week period. 5459. Drug Development (990) crn: 2539 (ONLINE) Expectations of Online Students. Use the Registration Form for Online Courses for this course. This course will use PSI Services LLC’s RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to PSI via credit card at the start of the proctored exam. 6:00 pm – 9:00 pm Tuesdays: May 18, 25, June 1, 8, 15, 22, 29, July 6, 13, 20, 27, Aug 3. Meets 12 times plus final exam. Make-ups, if needed, Aug 10 and 17. Proctored exam: June 29 (RPNow) Faculty: J. Hayes Required text: Drugs: From Discovery to Approval, Ng, 3rd edition, 2015 (ISBN-13:978-1118907276 or ISBN-10: 1118907272) Optional texts: Either The Drug Hunters: The Improbable Quest to Discover New Medicines, Kirsch, Ogas, ISBN: 13:978-1628729863 OR Viruses, Plagues, and History: Past, Present, and Future, revised edition (Oldstone, MD) (ISBN-10:0195327314) (ISBN-10: 0195327314). Not open to students who have completed RAQA 459. 5472. Pharmaceutical Marketing (990) crn: 11589 (ONLINE) Expectations of Online Students. Use the Registration Form for Online Courses for this course. This course will use PSI Services LLC’s RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to PSI via credit card at the start of the proctored exam. 6:00 pm – 9:00 pm Tuesdays: May 18, 25, June 1, 8, 15, 22, 29, July 6, 13, 20, 27, Aug 3. Meets 12 times plus final exam. Make-ups, if needed, Aug 10 and 17. Proctored exam: tba Faculty: D. Hisey Tentative required text: (do not purchase until confirmed): Pharmaceutical Marketing, Rollins and Perri, (ISBN-13: 978-1-449697990 or ISNG-10:1449697992). Not open to students who have completed RAQA 482. 5498. Computerized Systems Validation (990) crn: 11568 (ONLINE) Expectations of Online Students. Use the Registration Form for Online Courses for this course. This course will use PSI RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to PSI via credit card at the start of the proctored exam. 12:00 pm - 1:00 pm Tuesdays and Thursdays plus 1 recording weekly (posted Friday) which students watch at their convenience prior to the following class. Meets: May 18, 20 - watch recording before May 25 May 25, 27 - watch recording before June 1 June 1, 3 - watch recording before June 8 June 8, 10 - watch recording before June 15 June 15, 17 - watch recording before Jun 22 June 22, 24 (proctored exam) - watch recording before June 29 June 29, July 1 - watch recording before July 6 July 6, 8 - watch recording before July 13 July 13, 15 - watch recording before July 20 July 20, 22 - watch recording before July 27 July 27, 29 – watch recording before Aug 3 Aug 3, 5 – (no recording) Aug 10 (last class) Make-ups, if needed, Aug 12, 17. Proctored exam: June 24 (RPNow) Faculty: T. Preziosi No required text. Not open to students who have completed RAQA 498. 5539. Global Clinical Drug Development (990) crn: 11591 (ONLINE) Expectations of Online Students. Use the Registration Form for Online Courses for this course. This course will use PSI RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to PSI via credit card at the start of the proctored exam. 6:00 pm – 9:00 pm Tuesdays: May 18, 25, June 1, 8, 15, 22, 29, July 6, 13, 20, 27, Aug 3. Meets 12 times plus final exam. Make-ups, if needed, Aug 10 and 17. Proctored exam: June 29 (RPNow) Faculty: K. Weiss Required text; Not open to students who have completed RAQA 539. 5547. Project Management for Clinical Trials (990) crn: 11572 (ONLINE) Expectations of Online Students. Use the Registration Form for Online Courses for this course. This course will use PSI Services LLC’s RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to PSI via credit card at the start of the proctored exam. 6:00 pm – 9:00 pm Tuesdays: May 18, 25, June 1, 8, 15, 22, 29, July 6, 13, 20, 27, Aug 3. Meets 12 times plus final exam. Make-ups, if needed, Aug 10 and 17. Proctored exam: June 22 (RPNow) Faculty: J. Sheldon Recommended text: Project Management for the Pharmaceutical Industry, June 2011, revised reprint. Available on the Temple University Charles Library website. 5592. Food and Drug Law (991) crn: 5886 (ONLINE) Expectations of Online Students. Use the Registration Form for Online Courses for this course. This course will use PSI Services LLC’s RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to PSI via credit card at the start of the proctored exam. 6:00 pm – 9:00 pm Tuesdays: May 18, 25, June 1, 8, 15, 22, 29, July 6, 13, 20, 27, Aug 3. Meets 12 times plus final exam. Make-ups, if needed, Aug 10 and 17. Proctored exam: June 22 (RPNow). Faculty: G. Pilgrim Required text: Food and Drug Law: Cases and Materials, 4th end, Hutt, et al, West Academic Publishing, (ISBN: 1609301757). Only purchase the 4th edition (and not earlier editions). Recommended text: Statutory Supplement, Hutt, West Academic Publishing, (ISBN: 9781634591904). Note: a 2012 edition or later of this text is acceptable. West Academic Publishing gives a 15% discount and free ground shipping to students ordering these texts. You must create an account, use promo code HESTUDENT, and place your order directly through www.westacademic.com Not open to students who have completed RAQA 592. 5622. Unit Operations (990) crn: 11590 (ONLINE) Expectations of Online Students. Use the Registration Form for Online Courses for this course. This course will use PSI Services LLC’s RPNow online proctoring. Students are responsible for paying a $15.00 fee directly to PSI via credit card at the start of the proctored exam. Prerequisites: Students are expected to have a strong science background, including familiarity with chemistry, biology, and physics. Students should also have a basic understanding of pharmaceutical manufacturing processes. In addition, students need an aptitude in basic mathematical principles, including the ability to do calculations. 6:00 pm – 9:00 pm Tuesdays: May 18, 25, June 1, 8, 22, 29, July 6, 13, 20, 27, Aug 3, 10. No class June 15. Meets 12 times plus final exam. Make-ups if needed, Aug 17 and 24. Proctored exam: (RPNow) Faculty: D. Lebo |