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
- EU Annex 1 Draft Version 2020 (and once approved; final version)
- 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 Live21 - 22 May 2024Daily Schedule at a Glance
Training course times are listed in Central European Time (CET). 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 - 1300 Lunch 1300 - 1430 Course Content & Exercise 1430 - 1445 Break 1445 - 1615 Course Content & Exercise 1615 - 1630 Wrap-up, Questions, Discussion 0830 – 0845 Login 0845 - 0900 Recap 0900 - 1030 Course Content & Exercise 1030 - 1045 Break 1045 - 1215 Course Content & Exercise 1215 - 1300 Lunch 1300 - 1430 Course Content & Exercise 1430 - 1445 Break 1445 - 1615 Course Content & Exercise 1615 - 1630 Wrap-up, Questions, Discussion Registration Fee
*ISPE Membership is required for these registration rates.
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.
Cancellations/Refunds
Cancellations must be made in writing. If cancellations are received by 60 days prior to event start date, a full refund, minus a $150 handling fee, will be issued. After that time, no refunds will be granted. Please be advised that if your payment or written cancellation notice is not received prior to the cancellation date, your credit card will be charged the prevailing rate. Refund requests must be in writing and emailed or faxed to +1 (813)-264-2816. (Telephone messages are not accepted). ISPE reserves the right to modify the material or presenters for this event without notice, or cancel an event. If an event must be canceled, registrants will be notified by ISPE. ISPE will not be responsible for airfare penalties or other costs incurred due to cancellation.