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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
  • 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


2024 Course Dates

Spring Course: April 22 through 26
Fall Course: October 21 through 25

For advance registration, please contact Ms. Tyeasia Fields at or Harry Kochat at 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.



Who should attend?

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 and Location


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.


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.

Registration Fees

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 or Harry Kochat at

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
Transfer Policy
Paid registration is transferable once to any subsequent courses. If such transfers are coordinated with us more than 30 days prior to the course start-date, there will be no penalty. Any such course transfers within 30 days from the course start-date, there will be a penalty of 50% of the course fees.
Cancellation Policy
Any cancellation of registration outside 30-day window from the course start-date has no penalty. Unfortunately, there is no refund of paid registration  if attempt to cancel within 30-day window from the course start-date. However, you may substitute a colleague of your choice for the same course for which the participant originally registered with a nominal additional $250 processing fee. Under any unforeseen emergencies or unavoidable circumstances, if we have to cancel any schedules course prior to 30 days from the course start-date, The Plough Center shall notify all registered candidates promptly  with full refund of any paid registration. The Plough Center will not be responsible for airfare penalties or other costs incurred due to cancellation. Registrants are advised not to make travel arrangements more than 30 days in advance.


Feb 1, 2024