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Live eLearning - PDA 539.1 Technical Report No. 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology

Aug 03, 2020
8:30 AM
-
4:00 PM
| Eastern Standard Time
Online
  • Virtual
  • Education
  • Online
Closed

Overview

This training course is designed to provide and evaluate recommendations specific to the operation of Blow-Fill-Seal (BFS) technology for the manufacture of sterile pharmaceuticals, e.g., injectable, ophthalmic, parenteral, and inhalation drugs and medical devices. Supplemental information to assist users with interpretation of international standards and regulatory guidance regarding BFS operations will also be provided.

Basic knowledge of aseptic fill/finish packaging, cGMP and regulatory requirements is desired.

For more options and/or related training courses, please visit the page(s) below.

PDA Parenteral Packaging Training Courses

Trainers

Andrew W. Goll
Andrew W. Goll
Weiler Engineering, Inc.
Martin   Haerer
Martin Haerer
Rommelag CMO
Tim Kram
Tim Kram
Rommelag USA, Inc.

Learning Objectives

  1. Describe the recommended requirements necessary to utilize blow-fill-seal (BFS) fill/finish technology
  2. Assess if BFS technology can be applied to new or existing pharma products
  3. Describe the basic principles of BFS: cleanroom facility design, environmental monitoring, and aseptic processing
  4. Explain the process of evaluating product contact materials, extractable profiles and leachable risk
  5. Evaluate the aseptic risk of BFS in comparison to other advanced aseptic fill/finish operations: isolators and closed RABS systems

Who Should Attend

This training course is intended for professionals who are involved in sterile drug manufacturing using blow-fill-seal processes.

Departments
  • Quality Control
  • Manufacturing
  • Quality Assurance Operations
  • Research and Development
  • Technical Operations
  • Packaging

Roles
  • Specialist
  • Analyst
  • Supervisor
  • Manager
  • Engineer
  • Scientist

Registration Fees

Closed
Registration Type Price
Member $500
Non-member $500
Gov't/Health Auth./Academic $500

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