Announcing Course 5512 in the Spring 2015 Semester:

Microbiological Conceptsin Pharmaceutical

Manufacturing

Quality Assurance and Regulatory Affairs Graduate Program

Temple University School of Pharmacy425 Commerce Drive, Suite 175Fort Washington, PA 19034

Phone: 267.468.8560Fax: 267.468.8565

Email: qara@temple.eduwww.temple.edu/pharmacy_QARA

Microbiological Concepts in Pharmaceutical ManufacturingThis course is a rare opportunity to learn about pharmaceutical microbiology, the principles of sterile process control, and what can go wrong if GMPs are not followed. This science-based and practical course will provide a strong foundation for sound technical judgments and risk management decisions regarding sterile products.

These topics will be covered from a microbiological perspective:

• Manufacturing technologies and techniques and the needto build quality into processes

• The importance of vigilant daily oversight of a sterile operation

• Influence of raw material quality on finished productqualification and validation studies conducted by drug firms

• Key microbiological tests performed at in-process and finished product stages.

The course stresses practical matters and includes case studies to prepare students with a strong scientific and risk-based foundation.

Includes a field trip to the Global Headquarters of the Parenteral Drug Association in Bethesda, MD.

8:30 am - 3:00 pm Sundays: Jan 25, Feb 8, 22, Mar 8, 22, Apr 12. Field trip to PDA on either March 22 or March 29 (TBA).

This elective course in the QA/RA graduate program is 3 semester hours and counts towards the Certificate in GMPs for the 21st Century

Rick Friedman is Associate Director in the Office of Manufacturing and Product Quality in CDER. Rick haswritten several papers and chapters on sterile drugs, andhas had significant experience in evaluating sterile facilitydesign and control, and microbiology lab practices.

Tamara Ely is a Senior Policy Advisor at CDER, Office ofCompliance, Office of Manufacturing and Product Qual-ity. Tamara is a 2005 Temple QA/RA program graduatewith 15 years of experience.

QA/RA Graduate Program • Temple University School of Pharmacy425 Commerce Drive, Suite 175 • Fort Washington, PA 19034Phone: 267.468.8560 • Fax: 267.468.8565Email: qara@temple.edu • www.temple.edu/pharmacy_QARA

The Instructors