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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 & 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
  • Sartorius-Stedim
  • STERIS Corp
  • SCHOTT
  • Waters Corporation
  • Veltek
  • PharmaSys (IQ/OQ/PQ)
  • Cleanroom Experts
  • Regulatory Experts
  • Drug Development Experts
  • KOLs from Pharma Industry

Lab Instructors:

  • Kimberly Stewart Carrie
  • Gwendolyn Stornes
  • Howard Nguyen
  • Bivash Mandal
  • Nivesh Mittal
  • Dileep Reddy Janagam






 

2018 Course Dates

Course 1: April 9-13
Course 2: June 11-15
Course 3: August 27-31
Course 4: November 12-16

Register Online

*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 & 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 and Location

Schedule

Monday – Thursday: 8:00 AM – 5:00 PM

Friday : 8:00 AM – 12:00 Noon

Hotel shuttle from designated hotel will start dropping participants to the Plough Center from 7:30 AM till 8:00 AM and take participants back when the days schedule is over. If you would like to drive please make sure you arrive by 8:00 AM. Parking details will be provided in the welcome packet sent 2 weeks prior to the course start date.

(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. The laboratory program will be held in the Plough Center Laboratories at 3 North Dunlap St., Memphis, TN 38163.

Hotels

A block of rooms has been reserved for course participants at the following hotels.  All participants are responsible for making their own hotel arrangements.  Room reservations should be made NO LATER THAN 21 days in advance.


DoubleTree by Hilton Hotel - Memphis Downtown
185 Union Avenue
Memphis, TN 38103
Phone: 901-528-1800

Doubletree registration website
[To receive discounted rate, please call and book rooms using the code “L-UOT”]

SpringHill Suites Memphis Downtown
85 West Court Avenue
Memphis TN, 38103
Phone 901-522-2100

For Course 1: Not available
For Course 2: Book your group rate for UT ASEPTIC TRAINING
For Course 3: Book your group rate for UT ASEPTIC TRAINING
For Course 4: Book your group rate for UT ASEPTIC TRAINING

Crowne Plaza Memphis Downtown
300 North Second Street
Memphis TN, 38105
Phone 901-312-2361

For Course 1: UT Aseptic Course Training - March
For Course 2: UT Aseptic Course Training - June
For Course 3: UT Aseptic Course Training - August
For Course 4: UT Aseptic Course Training - October

  • Registration Fees

Standard Participant: $4,400

Academic/Government Participant: $2,200

Additional group discounts are available up on request (Please contact the course coordinator, Dr. Bivash Mandal at bmandal@uthsc.edu for details)

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. Sheredith Fountain (Phone: (901) 448- 1791;
Email: sfounta1@uthsc.edu) or Dr. Bivash Mandal (Email: bmandal@uthsc.edu; Phone: (901) 448- 2905)

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
  • 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.

Last Published: Nov 8, 2017