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 & 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 & Several Repeats
- Excellent Coverage of Principles of cGMP and GXP
- cGMP Operations, Documentation & Policies in Compliant with US-FDA
- Aseptic Compounding & Aseptic Processing
- Familiarizing with Sterile Manufacturing Process & Equipment
- Training Sterilization Principles and Processes
- Fundamentals of Quality Assurance & Quality Control
- GLP & GMP Testing Principles and Developing Methods
- Principles & Procedures of DQ, IQ, OQ, PQ & 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 & 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> & 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
- Corey Newell
- PJ Pulliam
- Tunde Raji
- Kimberly Carrie Stewart
- Surekha Surendranathan
2023 Course Dates
Spring Course: April 24 through 28
Fall Course: October 23 through 27
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.
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 & Regulatory QA/QC Personnel
- Field Regulators/ Compliant Inspectors
- Drug Research & Development Scientists
- Cleanroom Operators Seeking Refresher Training
- Beginners Interested in Learning Sterile Operations
- Pharmacy Individuals Seeking Cleanroom Behaviors
- CMC & Medical Regulatory Writers
- Contract Sterile Manufacturing Personnel
- Regulatory Consultants
- Sterile Processing Engineers
- Pharmacy School Students/ Interns/ Faculties
Schedule
Monday – Thursday: 8:00 AM – 5:00 PM
Friday : 8:00 AM – 12:00 Noon
(All times are US Central Time)
Location
All courses will be held on the campus of the University of Tennessee Health Science Center in Memphis (208 S. Dudley, Memphis, TN 38163.) The laboratory program will be held in the Plough Center Laboratories at 3 North Dunlap St., Memphis, TN 38163.
Hotels
Call Sheredith Fountain, Administrative Assistant, for updated hotel information.
For Course 1: UT Aseptic Course Training
For Course 2: UT Aseptic Course Training
For Course 3: UT Aseptic Course Training
Standard Participant: $4,500
Academic/Government Participant: $2,500
Preferred payment of the course fees is online using credit card. We also accept cashier’s check payable to “The University of Tennessee Health Science Center”. Course fees must be paid in full at least two weeks prior the course start-date as we have to fulfill quite a few logistic pre-requisites. For any payment related queries, please contact Ms. Tyeasia Fields at tfields5@uthsc.edu or Harry Kochat at hkochat@uthsc.edu.
The course fee include free parking, tuition, cleanroom and laboratory supplies as needed for hands-on training, Wi-Fi, daily delicious, variety breakfast, lunch and all day refreshments.
Register Online