Aseptic Processing & Annex 1 Training Course

Aseptic Processing & Annex 1 (T63) – New Course!

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 course will focus on aseptic processing and quality management around the most important pharmaceutical technology.

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

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
    Online Live
    - Online Live, United States
    13 - 16 Oct 2020

    Daily Schedule at a Glance

    Training times are listed in Eastern Standard Time (EST).
    Day 1
    0830 – 0845 Login & Registration
    0845 - 0900 Introductions
    0900 - 1030 Course Content & Exercise
    1030 - 1045 Break
    1045 - 1215 Course Content & Exercise
    1215 – 1230 Wrap-up, Questions & Discussions
    Day 2
    0830 – 0845 Login & Registration
    0845 - 0900 Recap
    0900 - 1030 Course Content & Exercise
    1030 - 1045 Break
    1045 - 1215 Course Content & Exercise
    1215 – 1230 Wrap-up, Questions & Discussions
    Day 3
    0830 – 0845 Login & Registration
    0845 - 0900 Recap
    0900 - 1030 Course Content & Exercise
    1030 - 1045 Break
    1045 - 1215 Course Content & Exercise
    1215 – 1230 Wrap-up, Questions & Discussions
    Day 4
    0830 – 0845 Login & Registration
    0845 - 0900 Recap
    0900 - 1030 Course Content & Exercise
    1030 - 1045 Break
    1045 - 1215 Course Content & Exercise
    1215 – 1230 Wrap-up, Questions & Discussions

    Featured Instructors

    Jörg Zimmermann

    Vice President, Vetter Development Service, External Affairs
    Vetter Pharma-Fertigung GmbH & Co.

    Registration Fee

    REGULAR
    Member US$ 1,785.00
    Nonmember   US$ 2,085.00
    Government / Academia US$ 550.00
    Student US$ 90.00

    Now Your Whole Team Can Participate in an ISPE 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.