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PDA EU00173 Best Practices and Points to Consider in Aseptic Processing

Oct 18 - Oct 19, 2021
2:00 PM
-
5:00 PM
| W. Europe Standard Time
Online
  • Virtual
  • Education
  • Europe
  • Online

Overview

Aim of this training course is to facilitate a deeper understanding and provide insights into the Aseptic Processing environment, and to go beyond what is commonly covered in books on that subject. A practical approach will enable participants to get actively involved, discussing guidelines and Warning Letters in addition to sharing perspectives and solutions to issues found in everyday job situations.

A kaleidoscope of hot topics such as Best Practices and Case Studies from different areas of Aseptic Processing, Sterile Production facilities, QA/ QC Microbiology Control, Shop Floor Mentoring and Oversight will be addressed. Training and Motivation of staff, use of Risk Assessments and Quality Culture are further relevant aspects.

Agenda

  • Day 1
  • Day 2
  • Monday, 18 October 2021

    Welcome and Collection of Expectations of Participants

    Important Aspects of Sterilization, Cleaning and Disinfection, Gowning Procedures

    Aspects of Clean Room Concepts and Good Aseptic Working Practices

  • Tuesday, 19 October 2021

    Best Practices in Aseptic Processing Simulation

    Effective Oversight at the Shop Floor, Good Training Methods

    Important Aspects in Environmental Monitoring

Trainers

Guenther Gapp
Guenther Gapp
Gapp Quality GmbH

Learning Objectives

  • Gain deeper knowledge and insights into specific topics like sterilization, training and motivation of shop-floor staff, correct aseptic working practices, media fill worst case criteria, effective environmental monitoring programs, good cleaning & disinfection practices, etc.
  • Understand key requirements and challenges in parenteral production
  • Understand the importance of a good quality culture within a company
  • Apply the executed and presented case studies and team exercises in her/his daily job
  • Get answers and interpretations about - potentially - unresolved questions and problems
  • Gain confidence for audits

Who Should Attend

Personnel involved in Aseptic Processing from sterile production departments such as:

  • Production Management and Shop Floor Supervisors
  • QA and QC Microbiologists
  • Qualified Persons
  • Personnel from technical department

A basic understanding of Aseptic Processing is a prerequisite.

Registration Fees

Register Now
Registration Type Price
All Participants €600

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