Aseptic Processing and Annex 1 Online Live Training

ISPE Learning Solution - Online Live Training Online Live

Overview

Driven by biopharmaceuticals but also prominent in small molecules drug manufacturing as well as for APIs, aseptic processing will undergo a technology jump start driven by the new EC GMP Guide Annex 1. Globally supplying companies, which deliver drugs to Europe, must comply with this new regulatory requirement. There is an impact for all stakeholders of manufacturing, across hierarchy levels and various functions at manufacturers. Also, suppliers have to consider Annex 1 when supplying new equipment or installing new production facilities. This 2-day online course will focus on aseptic processing and quality management around the most important pharmaceutical technology.

Supporting Documents:

  • EC GMP Guide Annex 1, 2018
  • FDA CFR 210 and 211

View Dates


What You Will Learn

  • Upon completing this course, you will be able to:
  • Understand the new EC GMP Guide Annex 1 and its impact on future aseptic processing
  • Determine the current industry standards for manufacturing and environmental control
  • Engage in critical topics discussion in regulators inspections

Resources and Activities

  • Pre-Course Work Materials
  • Interactive Exercises
  • Learning Assessments

Online Live Course Modules

  • Introduction to the Regulatory Framework
  • Hot Topics from Annex 1 Draft
  • Interaction of Process and Aseptic Fill/Finish Operations
  • Principles of Aseptic Processing
  • Process Development and Validation
  • Quality Risk Management
  • Training Systems
  • Interactive Session/Case-Based Learning
  • How to Prepare for Regulatory Inspections

Who Should Attend

  • Managers of production and quality assurance
  • Process engineers
  • Engineers responsible for infrastructure and maintenance
  • Quality managers
  • Shop floor supervisors
  • Middle management
  • Department heads
  • Suppliers for equipment and infrastructure of aseptic manufacturing plants

Daily Schedule and Pricing

  • Online Live
    16 - 17 July

    Daily Schedule at a Glance

    Day 1
    0900 – 0915 Login & Registration
    0915 - 0930 Introductions
    0930 - 1045 Course Content & Exercise
    1045 - 1100 Break
    1100 - 1215 Course Content & Exercise
    1215 - 1245 Lunch
    1245 - 1430 Course Content & Exercise
    1430 - 1445 Break
    1445 - 1615 Course Content & Exercise
    1615 - 1630 Questions & Discussions
    All times for this training course date are displayed in CET.
    Day 2
    0900 Login
    0915 - 1030 Course Content & Exercise
    1030 - 1045 Break
    1045 - 1145 Course Content & Exercise
    1145 - 1200 Questions & Wrap-up
    All times for this training course date are displayed in CET.

    Registration Fee

    EARLY

    On or Before 9 July 

    Member US$1,495 
    Nonmember US$1,695   
    Government/Academia US$550
    Student US$90
    LATE

    On or After 10 July

    Member US$1,595   
    Nonmember   US$1,795   
    Government/Academia US$550
    Student US$98

    Mail or Fax Registration

    Not paying by credit card? Use the registration form to pay by mail or by fax.


    Now Your Whole Team Can Participate in an ISPE Online Live Learning Experience

    • 3 - 5 participants - Save 10%
    • 6 - or more participants - Save 20%

    Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, ask@ispe.org.


    Instructor

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