Tuesday, January 23, 2018
11:30 – 1:00 pm EST
Instructor: Marsha Steed (Hardiman)
Manufacturing of pharmaceutical, biopharmaceutical or medical device products via aseptic processing requires knowledge and understanding of the basic principles of Microbiology in order to manage the aseptic operations and produce sterile products. Lack of understanding about good aseptic technique, proper facility design, adequate cleaning and correct cleanroom behaviors can lead to contamination of product, time consuming investigations and rejection of production batches. In this course we will discuss:
In this course we will discuss:
- Fundamentals and importance of facility design plays in aseptic processing
- Basics of Microbiology related to aseptic processing
- Aseptic technique and clean room behaviors
- Importance of the clean room cleaning and sanitization program
- Role of environmental monitoring in aseptic processing
- Aseptic Simulations
- FDA expectations as well as other global regulations for aseptic processing
- Importance of application of risk management to aseptic processing
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-006