Overview regulatory frameworks and drug substance/drug product manufacturing requirements | Day 1 of the "mRNA intensive training" (10583)

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 1

Session 1: Introduction and Comprehensive Overview over Regulations
09/05/2023 at 08:30 - 10:00 CET - Fritz Röder

• Overview
• EMA Guidelines and pharmacopoeia
• ICH guidelines
• mRNA and ATMP
• mRNA and Biologics

Coffee Break

Session 2: Facility Layout, Personnel & Material Flow, Utilities
09/05/2023 at 10:15 - 11:30 CET - Fritz Röder

• Comparing production layouts
• Identifying critical aspects for mRNA in facility layouts
• Media supply considerations for mRNA

Coffee Break

Session 3: Manufacturing: Drug Substance and Drug Product
09/05/2023 at 11:45 - 12:45 CET - Fritz Röder

• Basic requirements for manufacture
• Starting and raw materials
• Manufacturing processes
• Critical parameters and critical aspects

Q&A
09/05/2023 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 1: 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 1, three parts per trained person will be deducted. For team training, please contact us.