Microbial / viral contamination and product cross-contamination are two of the major challenges faced by manufacturing companies within GMP regulated industries. Contamination will affect the drug product's safety, identity, strength, quality and purity. The adulterated drug product will pose significant risk to patient safety.
An effective preventive measure is to design an effective cleaning process, and also understand various causes of contamination and the strategies for remediation and preventive measures.
Key take away from this seminar are the understanding of the regulations related to cleaning, important elements of cleaning process design, strategies of remediation of biofilm and rouge formation in water system / process equipment.
The common cleaning challenges encountered in GMP manufacturing are also discussed, including the strategies of remediation.
Senior Technical Service Manager
Life Sciences, Formulated Chemistries
STERIS Corporation (read more)
Technical Service Manager
Life Sciences, Formulated Chemistries
STERIS Corporation (read more)
08.30 - 09.00 am |
Registration |
09.00 - 10.15 am |
Cleaning Process Design Considerations |
10.15 - 10.45 am |
Tea Break |
10.45 - 12.00 pm |
Cleaning Process Design Considerations |
12.00 - 01.00 pm |
Lunch Break |
01.00 - 02.00 pm |
Microbial contamination and remediation in water system / process equipment |
02.00 - 03.00 pm |
Strategies for remediation and prevention of rouge |
03.00 - 03.30 pm |
Tea Break |
03.30 - 04.00 pm |
Virus safety of cleaned surfaces |
04.00 - 04.30 pm |
Cleaning challenges and how to overcome them |
04.30 - 05.00 pm |
Q&A |
*Early Bird rates valid for registrations before 10 May 2019