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Comprehensive Pharmaceutical Aseptic Course - June

: 10 Jun 2019 - 14 Jun 2019

: Memphis, United States

Sector: Pharmaceutical

Type: Training


Course key Objectives

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

Find out more / register here:

Venue

Memphis
TN
United States


Organizer

The University of Tennesse - Health Science Center
Phone: 901.448.1440
Email: hkochat@uthsc.edu
Visit: https://www.uthsc.edu


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