Sterile filling, QC testing and process validation strategies | Day 2 of the "mRNA intensive training" (10584)

This training will give the participants a basic understanding of the world of mRNA manufacturing. It will comprise manufacturing topics concerning Drug Substance as well as Drug Product and Finished Product. Moreover, process control strategies, analytics, and storage and transport requirements will be discussed. The trainers have experience with several manufacturing sites in the mRNA business.

The participants will obtain detailed information about the manufacturing and quality characteristics from smaller scale to larger scale. In addition, facility layouts, material and personnel flows as well as utility requirements will be discussed.

The training is divided into nine sessions and well-suited for engineers, QA and QC representatives, manufacturing experts, regulatory, technical SMEs, Q&V specialists as well as chemical and microbiological laboratory representatives.

You can also book the days separately if you are interested.

Key aspects of the entire 9-part series:

• Regulatory topics
• Facility and utility requirements
• GMP aspects
• Manufacturing of mRNA: Drug Substance, Drug Product, Finished Product
• Sterile filling
• Validation strategies
• Qualification of materials
• How to set up a specification
• Analytical details and QTPP
• Scale-up and change management

Day 2

Session 4: Manufacturing: Finished Product, Warehousing, Transport
10/05/2023 at 08:30 - 10:00 CET - Fritz Röder

• Specific requirements for sterile filling
• How to carry out pharmaceutical packaging
• mRNA and packaging processes

Coffee Break

Session 5: Analytical Methods and Quality Testing
10/05/2023 at 10:15 - 11:30 CET - Dr. Felix Kern

• Development (R&D)
• Analytical methods
• Overview of QC requirements
• Batch release testing for mRNA medicinal products
• Detailed analytical discussion

Coffee Break

Session 6: Quality Profile and Validation
10/05/2023 at 11:45 - 12:45 CET - Dr. Felix Kern

• Basic requirements for process validation
• Stepwise requirements for process validation
• New validation concepts
• Specificities of mRNA production processes

Q&A
10/05/2023 at 12:45 - 13:00CET - Fritz Röder/ Dr. Felix Kern

• Answer of questions received from attendees before the training
• Answers of questions received via chat

Duration of day 2: approx. 4 hours

Duration of the series in total: approx. 12 hours
Lecture language: English | Slides: English

...more from your speaker Dr. Felix Kern
...more from your speaker Fritz Röder

We offer attractive special prices with special benefits for large groups - please contact us.

You cannot attend the live event? No problem. Please inform us at the time of booking that you would like to stream the webinar at a later date.

Note on quota call-off: When booking the day 2, three parts per trained person will be deducted. For team training, please contact us.