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
*Distinguished Lectures From:
- Plough Center for Sterile Drug Delivery Solutions
- Amgen
- EMD Millipore
- Kimberly-Clark
- STERIS Corp
- SCHOTT
- Waters Corporation
- Cleanroom Experts
- Regulatory Experts
- Drug Development Experts
- KOLs from Pharma Industry
- SP Scientific
- Saint Gobain
- Millipore Sigma
- Particle Measuring Systems (PMS)
*Industry speakers based on their availability
Lab Instructors:
- Jon Chapman
- Julia Davis
- Victor Francis Helmy
- Peter Hunter
- Jeri Mosby
- PJ Pulliam
- Tunde Raji
- Kimberly Carrie Stewart
2025 Course Dates
Spring Course: April 21st - 25th 2025
Fall Course: October 20th - 24th 2025.
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.
Our thoughtful design of the course after extensive research and analysis made the course suitable for graduate students seeking pharmaceutical career, pharmaceutical professionals who are involved in sterile manufacturing or have been recently reassigned to it and for science loving personnel who wish to make a career change or transformation. In summary, tour course content is designed to accommodate personnel with various levels of experience. Our attendee list generally includes the following:
- Sterile Compounding Pharmacists
- Aseptic Manufacturing Personnel
- CMC and Regulatory QA/QC Personnel
- Field Regulators/ Compliant Inspectors
- Drug Research and Development Scientists
- Cleanroom Operators Seeking Refresher Training
- Beginners Interested in Learning Sterile Operations
- Pharmacy Individuals Seeking Cleanroom Behaviors
- CMC and Medical Regulatory Writers
- Contract Sterile Manufacturing Personnel
- Regulatory Consultants
- Sterile Processing Engineers
- Pharmacy School Students/ Interns/ Faculties
Schedule
All times are US Central Time
Monday – Thursday: 8:00 am – 5:00 pm
Friday : 8:00 am – 12:00 Noon
**Please note, due to the shortened day on Friday, lunch will not be provided.
Location
All courses will be held on the campus of the University of Tennessee Health Science Center in Memphis. The Plough Center is located at 208 South Dudley, Memphis, TN 38163.
Standard Participant: $5,000
Academic Participant: $1,750
Government Participant: $3,500
UT Health Science Center Student Participant: Complimentary
Preferred payment of the course fee is online using credit card. Course fees must be paid in full at least two weeks prior the course start-date. For any payment related queries, please contact Ms. Tyeasia Fields at tfields5@uthsc.edu or Harry Kochat at hkochat@uthsc.edu.
The course fee includes tuition, parking, daily breakfast and lunch, cleanroom and laboratory supplies, and Wi-Fi. All-day refreshments will also be available.
Register Online