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 course will focus on aseptic processing and quality management around the most important pharmaceutical technology.
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
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Online Live25 - 28 Jan 2021Daily Schedule at a Glance
Training course times are listed in Eastern Standard Time (EST). Find your personal viewing time on the World Clock.
0830 – 0845 Login 0845 - 0900 Introductions 0900 - 1030 Course Content & Exercise 1030 - 1045 Break 1045 - 1215 Course Content & Exercise 1215 - 1230 Wrap-up, Questions, Discussion 0830 – 0845 Login 0845 - 0900 Recap 0900 - 1030 Course Content & Exercise 1030 - 1045 Break 1045 - 1215 Course Content & Exercise 1215 - 1230 Wrap-up, Questions, Discussion 0830 – 0845 Login 0845 - 0900 Recap 0900 - 1030 Course Content & Exercise 1030 - 1045 Break 1045 - 1215 Course Content & Exercise 1215 - 1230 Wrap-up, Questions, Discussion 0830 – 0845 Login 0845 - 0900 Recap 0900 - 1030 Course Content & Exercise 1030 - 1045 Break 1045 - 1215 Course Content & Exercise 1215 - 1230 Wrap-up, Questions, Discussion Featured Instructors
Joerg Zimmermann
Vice President, Vetter Development Service, External AffairsVetter Pharma-Fertigung GmbH & Co.
Registration Fee
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.