Comprehensive Pharmaceutical Aseptic Course

The Comprehensive Industrial Course in the Preparation of Parenteral Products includes a comprehensive overview of the fundamental concepts utilized in the preparation of parenteral products. Participants work in small groups to prepare a small volume parenteral (SVP) product and perform relevant quality control tests and environmental evaluations. Emphasis is on principles of aseptic processes and current trends in quality.

Course key Objectives

During the course, participants will:

• Get hands-on experience with aseptic compounding and fill-finish
• Practice environmental monitoring and quality control techniques
• Learn the principles of cleaning and sanitization
• Understand regulatory trends in aseptic processing industry
• Interact with other participants, invited speakers and Plough Center personnel

Some of the key Topics:

• One and Only in True-Cleanroom Hands-on Training Program
• Hundreds of Satisfied Participants Globally and Several Repeats
• Excellent Coverage of Principles of cGMP and GXP
• cGMP Operations, Documentation and Policies  in Compliant with US-FDA
• Aseptic Compounding and Aseptic Processing
• Familiarizing with Sterile Manufacturing Process and Equipment
• Training Sterilization Principles and Processes
• Fundamentals of Quality Assurance and Quality Control
• GLP and GMP Testing  Principles and Developing Methods
• Principles and Procedures of DQ, IQ, OQ, PQ and CQ
• Analytical and Process Validations
• Discovery Formulation to Clinical Formulation
• Autoclave and Lyophilization Cycle Development
• Cleanroom Cleaning and Sanitization (EM Program)
• Site Inspection/ Audit Trend
• Cytotoxics, Biologics and Small Molecules: Sterile Facility Design to Patient Side
• Sterile injectable Drug Development: FDA expectations
• Trending FDA Inspection and Readiness for Various Types of Site Inspection

• Pharmaceutical Compounding USP<797> and USP<800> methods

For advance registration, please contact Ms. Tyeasia Fields at tfields5@uthsc.edu or Harry Kochat at hkochat@uthsc.edu. You can also call 901.448.1440.

*Advanced registration is required and to maximize interaction and allow for individualized instruction, the number of spots are limited. Please review the registration policies below and enroll using this link.